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Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00486525
Collaborator
National Cancer Institute (NCI) (NIH)
200
Enrollment
1
Location
2
Arms
67
Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer survivors.

PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving physical activity, inflammation, fatigue, and distress in female breast cancer survivors.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Yoga Therapy
 N/A

Detailed Description

OBJECTIVES:

Primary

  • To determine if the yoga intervention will decrease inflammation, fatigue, and depressive symptoms relative to the waiting-list controls in women who are stage 0-IIIa breast cancer survivors.

OUTLINE: Patients are stratified according to stage of cancer (stage 0 vs stage I vs stage II and stage IIIA) and prior radiation therapy (yes vs no). Patients are randomized to 1 of 2 intervention arms.

  • Arm I (waiting-list control): Patients are encouraged to perform usual activities, but asked to refrain from any yoga practice or other related activities. After a six-month observation period, patients undergo yoga intervention as described in arm II .

  • Arm II (yoga intervention): Patients participate in a Hatha yoga intervention session comprising body postures and breath control techniques for 1.5 hours twice a week for 12 weeks. Patients are encouraged to practice Hatha yoga at home. Patients complete daily diaries on home Hatha yoga practices and submit them at each session.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress
Study Start Date :
Aug 1, 2007
Actual Primary Completion Date :
Nov 1, 2012
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I: Yoga Therapy

Patients participate in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients are also encouraged to practice yoga at home using the appropriate DVD/video segments for the month.

Procedure: Yoga Therapy
Patients will undergo yoga therapy
Other Names:
  • Yoga

    		•
    No Intervention: Arm II: Wait-List

    Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.

    Outcome Measures

    Primary Outcome Measures

    1. Stimulated ln (TNF-a) [Immediately post-treatment and 3 months post-treatment]

      log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)

    2. Stimulated ln (IL-6) [Immediately post-treatment and 3 months post-treatment]

      log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)

    3. Stimulated ln (IL-1b) [Immediately post-treatment and 3 months post-treatment]

      log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)

    4. MFSI-SF Fatigue [Immediately post-treatment and 3 months post-treatment]

      The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue. Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue.

    5. Vitality, SF-36 [Immediately post-treatment and 3 months post-treatment]

      The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month. Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue.

    6. CES-D [Immediately post-treatment and 3 months post-treatment]

      The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale. Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Stage 0-IIIA breast cancer survivor

    • Completed cancer treatment within the past 36 months (except for tamoxifen/aromatase inhibitors)

    • At least 2 months since prior surgery, adjuvant therapy, or radiotherapy, whichever occurred last

    • Women who are not currently practicing yoga and have not participated in any of the following activities:

    • Meditation, tai chi, or related activities

    • Yoga or tai chi within the past 6 months

    • Had classes for or practiced yoga for more than 3 months

    • Women who typically engage in a total of 5 or more hours of vigorous physical activity per week are not eligible

    • No inflammatory breast cancer

    PATIENT CHARACTERISTICS:
    Inclusion criteria:

    • Hemoglobin ≥ 10 g/dL (patients with a hemoglobin of < 10 g/dL may be retested in 6 weeks after treatment of anemia and allowed to participate in study if blood counts recovered)

    • Physically able to fully participate in yoga intervention

    Exclusion criteria:

    • Inability to comfortably get up and down from the floor 2-3 times in a session

    • Breathing problems requiring use of oxygen

    • Problems walking without a cane or walker assistance

    • Prior knee or hip replacement with limited movement in the joint

    • Inability to comfortably lie on the stomach

    • Alcohol, or drug abuse

    • Diagnosis of any of the following conditions:

    • Diabetes

    • Chronic obstructive pulmonary disease

    • Uncontrolled hypertension

    • Evidence of liver or kidney failure

    • Symptomatic ischemic heart disease

    • Significant visual or auditory problems

    • Mental disorder or cognitive impairment

    • Notable serious cardiovascular history (e.g., prior life-threatening abnormal heart rhythms)

    • Other medical conditions involving the immune system such as autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis

    • History of breast or any other cancer, except basal or squamous cell skin cancer

    PRIOR CONCURRENT THERAPY:

    • See Disease Characteristics

    • No regular use of medications with major immunological consequences (e.g., steroids)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210-1240

    Sponsors and Collaborators

    • Ohio State University Comprehensive Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Janice Kiecolt-Glaser, PhD, Ohio State University Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Janice Kiecolt-Glaser, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00486525
    Other Study ID Numbers:
    • OSU-06137
    • NCI-2012-00564
    • R01CA126857
    • NCT00526526
    First Posted:
    Jun 14, 2007
    Last Update Posted:
    May 5, 2014
    Last Verified:
    Apr 1, 2014
    Keywords provided by Janice Kiecolt-Glaser, Principal Investigator, Ohio State University Comprehensive Cancer Center
    fatigue
    depression
    pain
    cancer survivor
    stage IA breast cancer
    stage IB breast cancer
    stage II breast cancer
    stage IIIA breast cancer
    breast cancer in situ
    Additional relevant MeSH terms:
    Breast Neoplasms
    Inflammation
    Fatigue
    Depression

    Study Results

    Participant Flow

    Recruitment Details We enrolled a sample of 200 breast cancer survivors with respect to age, stage of cancer, and treatment modalities between October 2007 and April 2012 in the Ohio State University Medical Center. Women were recruited through oncologists' referrals, community print and web-based announcements, and breast cancer groups and events.
    Pre-assignment Detail We assessed functional limitations during the screening session. Those who had mobility/functional limitations were dropped out before randomization.
    Arm/Group Title Arm I: Yoga Therapy Arm II: Wait-List
    Arm/Group Description Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs. Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
    Period Title: Overall Study
    STARTED 100 100
    COMPLETED 94 87
    NOT COMPLETED 6 13

    Baseline Characteristics

    Arm/Group Title Arm I: Yoga Therapy Arm II: Wait-List Total
    Arm/Group Description Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs. Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes. Total of all reporting groups
    Overall Participants 100 100 200
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    51.8
    (9.8)
    51.3
    (8.7)
    51.6
    (9.2)
    Sex: Female, Male (Count of Participants)
    Female
    100
    100%
    100
    100%
    200
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    BMI (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    27.9
    (5.3)
    27.6
    (6.0)
    27.8
    (5.7)
    SAD (cm) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [cm]
    20.7
    (3.3)
    21.0
    (3.6)
    20.8
    (3.4)
    Ethnicity (participants) [Number]
    Asian
    3
    3%
    2
    2%
    5
    2.5%
    Black or African American
    8
    8%
    10
    10%
    18
    9%
    White
    88
    88%
    88
    88%
    176
    88%
    Not Reported
    1
    1%
    0
    0%
    1
    0.5%
    CES-D depressive symptoms (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    10.2
    (8.2)
    11.2
    (8.2)
    10.7
    (8.2)
    Usage of Cardiac Medication (participants) [Number]
    Number [participants]
    17
    17%
    16
    16%
    33
    16.5%
    CHAMPS activity (total hours/week) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [total hours/week]
    6.8
    (6.3)
    5.8
    (5.1)
    6.3
    (5.7)
    MFSI-SF Fatigue (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    14.3
    (19.6)
    17.3
    (20.5)
    15.8
    (20.1)
    SF-36 Vitality (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    48.6
    (20.2)
    44.4
    (20.9)
    46.5
    (20.6)
    Marital Status (participants) [Number]
    Single
    18
    18%
    8
    8%
    26
    13%
    Married
    68
    68%
    72
    72%
    140
    70%
    Separated/Divorced
    14
    14%
    15
    15%
    29
    14.5%
    Widowed
    0
    0%
    5
    5%
    5
    2.5%
    Education level (participants) [Number]
    High School or Less
    5
    5%
    7
    7%
    12
    6%
    Some College
    27
    27%
    22
    22%
    49
    24.5%
    College Grad
    29
    29%
    33
    33%
    62
    31%
    Postgraduate
    39
    39%
    38
    38%
    77
    38.5%
    Employment Status (participants) [Number]
    Employed full or part time
    71
    71%
    66
    66%
    137
    68.5%
    Unemployed
    15
    15%
    20
    20%
    35
    17.5%
    Retired
    14
    14%
    14
    14%
    28
    14%
    Income level (participants) [Number]
    $0-$25,000
    3
    3%
    7
    7%
    10
    5%
    $25,000-$50,000
    18
    18%
    15
    15%
    33
    16.5%
    $50,000-$75,000
    17
    17%
    18
    18%
    35
    17.5%
    $75,000-$100,000
    23
    23%
    23
    23%
    46
    23%
    >$100,000
    30
    30%
    29
    29%
    59
    29.5%
    No report
    9
    9%
    8
    8%
    17
    8.5%
    Type of Treatment (participants) [Number]
    Surgery Only
    13
    13%
    13
    13%
    26
    13%
    Surgery + Radiation
    28
    28%
    24
    24%
    52
    26%
    Surgery + Chemotherapy
    23
    23%
    23
    23%
    46
    23%
    Surgery + Radiation + Chemotherapy
    36
    36%
    40
    40%
    76
    38%
    Cancer Stage (participants) [Number]
    Stage 0
    9
    9%
    9
    9%
    18
    9%
    Stage I
    46
    46%
    43
    43%
    89
    44.5%
    Stage IIA
    27
    27%
    25
    25%
    52
    26%
    Stage IIB
    10
    10%
    13
    13%
    23
    11.5%
    Stage IIIA
    8
    8%
    10
    10%
    18
    9%
    HER2 Receptor Status (participants) [Number]
    Positive
    18
    18%
    17
    17%
    35
    17.5%
    Negative
    74
    74%
    72
    72%
    146
    73%
    Unknown
    8
    8%
    11
    11%
    19
    9.5%
    Progesterone Receptor Status (participants) [Number]
    Positive
    73
    73%
    69
    69%
    142
    71%
    Negative
    23
    23%
    26
    26%
    49
    24.5%
    Unknown
    4
    4%
    5
    5%
    9
    4.5%
    Estrogen Receptor Status (participants) [Number]
    Positive
    81
    81%
    78
    78%
    159
    79.5%
    Negative
    15
    15%
    17
    17%
    32
    16%
    Unknown
    4
    4%
    5
    5%
    9
    4.5%
    Usage of Tamoxifen/Aromatase Inhibitors (participants) [Number]
    Number [participants]
    72
    72%
    71
    71%
    143
    71.5%
    Post-menopausal (participants) [Number]
    Number [participants]
    76
    76%
    77
    77%
    153
    76.5%
    Time since diagnosis (months) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [months]
    16.3
    (7.5)
    18.4
    (8.5)
    17.3
    (8.1)
    Time since treatment (months) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [months]
    9.9
    (7.1)
    11.8
    (8.5)
    10.9
    (7.9)

    Outcome Measures

    1. Primary Outcome
    Title Stimulated ln (TNF-a)
    Description log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)
    Time Frame Immediately post-treatment and 3 months post-treatment

    Outcome Measure Data

    Analysis Population Description
    Any subjects who do not have any measurements post-baseline are excluded from analyses.
    Arm/Group Title Arm I: Yoga Therapy Arm II: Wait-List
    Arm/Group Description Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs. Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
    Measure Participants 92 84
    Immediately post-treatment
    8.31
    (0.041)
    8.39
    (0.040)
    3 months post-treatment
    8.31
    (0.042)
    8.44
    (0.043)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.20
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.075
    Confidence Interval (2-Sided) 95%
    -0.19 to 0.039
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.058
    Estimation Comments Yoga minus Control immediately post-treatment
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.027
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.13
    Confidence Interval (2-Sided) 95%
    -0.25 to -0.015
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.06
    Estimation Comments Yoga minus Control 3 months post-treatment
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Secondary analysis on change of ln (TNF-a) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.28
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.021
    Confidence Interval (2-Sided) 95%
    -0.060 to 0.018
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.02
    Estimation Comments Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Secondary analysis on change of ln (TNF-a) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.063
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.038
    Confidence Interval (2-Sided) 95%
    -0.079 to 0.0021
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.02
    Estimation Comments Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.
    2. Primary Outcome
    Title Stimulated ln (IL-6)
    Description log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)
    Time Frame Immediately post-treatment and 3 months post-treatment

    Outcome Measure Data

    Analysis Population Description
    Any subjects who do not have any measurements post-baseline are excluded from analyses.
    Arm/Group Title Arm I: Yoga Therapy Arm II: Wait-List
    Arm/Group Description Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs. Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
    Measure Participants 92 84
    Immediately post-treatment
    9.68
    (0.043)
    9.76
    (0.044)
    3 months post-treatment
    9.69
    (0.044)
    9.85
    (0.047)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.079
    Confidence Interval (2-Sided) 95%
    -0.2 to -0.042
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.062
    Estimation Comments Yoga minus Control immediately post-treatment
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.015
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.16
    Confidence Interval (2-Sided) 95%
    -0.28 to -0.031
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.064
    Estimation Comments Yoga minus Control 3 months post-treatment
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.022
    Confidence Interval (2-Sided) 95%
    -0.063 to 0.019
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.021
    Estimation Comments Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.01
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.056
    Confidence Interval (2-Sided) 95%
    -0.098 to -0.013
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.022
    Estimation Comments Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.
    3. Primary Outcome
    Title Stimulated ln (IL-1b)
    Description log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)
    Time Frame Immediately post-treatment and 3 months post-treatment

    Outcome Measure Data

    Analysis Population Description
    Any subjects who do not have any measurements post-baseline are excluded from analyses.
    Arm/Group Title Arm I: Yoga Therapy Arm II: Wait-List
    Arm/Group Description Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs. Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
    Measure Participants 92 84
    Immediately post-treatment
    8.31
    (0.077)
    8.42
    (0.071)
    3 months post-treatment
    8.32
    (0.079)
    8.55
    (0.074)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.33
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.10
    Confidence Interval (2-Sided) 95%
    -0.31 to 0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.11
    Estimation Comments Yoga minus Control immediately post-treatment
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.037
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.23
    Confidence Interval (2-Sided) 95%
    -0.44 to -0.014
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.11
    Estimation Comments Yoga minus Control 3 months post-treatment
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.33
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.034
    Confidence Interval (2-Sided) 95%
    -0.10 to 0.035
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.0235
    Estimation Comments Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.03
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.078
    Confidence Interval (2-Sided) 95%
    -0.15 to -0.0074
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.036
    Estimation Comments Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.
    4. Primary Outcome
    Title MFSI-SF Fatigue
    Description The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue. Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue.
    Time Frame Immediately post-treatment and 3 months post-treatment

    Outcome Measure Data

    Analysis Population Description
    Any subjects who do not have any measurements post-baseline are excluded from analyses.
    Arm/Group Title Arm I: Yoga Therapy Arm II: Wait-List
    Arm/Group Description Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs. Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
    Measure Participants 96 90
    Immediately post-treatment
    6.1
    (1.7)
    10.3
    (1.4)
    3 months post-treatment
    5.4
    (1.7)
    12.4
    (1.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.058
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -4.2
    Confidence Interval (2-Sided) 95%
    -8.5 to 0.15
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.2
    Estimation Comments Yoga minus Control immediately post-treatment
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -7.0
    Confidence Interval (2-Sided) 95%
    -11.4 to -2.7
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.2
    Estimation Comments Yoga minus Control 3 months post-treatment
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Secondary analysis on change of MFSI-SF Fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.019
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Slope
    Estimated Value -1.7
    Confidence Interval (2-Sided) 95%
    -3.1 to -0.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.70
    Estimation Comments Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Secondary analysis on change of MFSI-SF fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Slope
    Estimated Value -2.8
    Confidence Interval (2-Sided) 95%
    -4.2 to -1.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.71
    Estimation Comments Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.
    5. Primary Outcome
    Title Vitality, SF-36
    Description The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month. Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue.
    Time Frame Immediately post-treatment and 3 months post-treatment

    Outcome Measure Data

    Analysis Population Description
    Any subjects who do not have any measurements post-baseline are excluded from analyses.
    Arm/Group Title Arm I: Yoga Therapy Arm II: Wait-List
    Arm/Group Description Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs. Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
    Measure Participants 96 90
    Immediately post-treatment
    58.7
    (1.9)
    52.3
    (1.7)
    3 months post-treatment
    58.1
    (1.9)
    51.6
    (1.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.01
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.4
    Confidence Interval (2-Sided) 95%
    1.4 to 11.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.5
    Estimation Comments Yoga minus Control immediately post-treatment
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.01
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 6.6
    Confidence Interval (2-Sided) 95%
    1.5 to 11.6
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.5
    Estimation Comments Yoga minus Control 3 months post-treatment
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.016
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Slope
    Estimated Value 2.1
    Confidence Interval (2-Sided) 95%
    0.40 to 3.75
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.85
    Estimation Comments Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0045
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Slope
    Estimated Value 2.5
    Confidence Interval (2-Sided) 95%
    0.77 to 4.14
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.85
    Estimation Comments Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.
    6. Primary Outcome
    Title CES-D
    Description The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale. Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms.
    Time Frame Immediately post-treatment and 3 months post-treatment

    Outcome Measure Data

    Analysis Population Description
    Any subjects who do not have any measurements post-baseline are excluded from analyses.
    Arm/Group Title Arm I: Yoga Therapy Arm II: Wait-List
    Arm/Group Description Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs. Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
    Measure Participants 96 90
    Immediately post-treatment
    8.1
    (0.69)
    9.2
    (0.70)
    3 months post-treatment
    8.5
    (0.69)
    9.7
    (0.71)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.28
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -3.0 to 0.88
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.98
    Estimation Comments Yoga minus Control immediately post-treatment
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.21
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.3
    Confidence Interval (2-Sided) 95%
    -3.2 to 0.69
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.99
    Estimation Comments Yoga minus Control 3 months post-treatment
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Secondary analysis on change of CES-D for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.051
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.66
    Confidence Interval (2-Sided) 95%
    -1.3 to 0.0039
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.34
    Estimation Comments Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Arm I: Yoga Therapy, Arm II: Wait-List
    Comments Secondary analysis on change of CESD for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.098
    Comments
    Method Mixed Models Analysis
    Comments The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.56
    Confidence Interval (2-Sided) 95%
    -1.2 to 0.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.34
    Estimation Comments Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.

    Adverse Events

    Time Frame Post-intervention
    Adverse Event Reporting Description
    Arm/Group Title Arm I: Yoga Therapy Arm II: Wait-List
    Arm/Group Description Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs. Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
    All Cause Mortality
    Arm I: Yoga Therapy Arm II: Wait-List
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Arm I: Yoga Therapy Arm II: Wait-List
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/100 (0%) 0/100 (0%)
    Other (Not Including Serious) Adverse Events
    Arm I: Yoga Therapy Arm II: Wait-List
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/100 (2%) 0/100 (0%)
    Musculoskeletal and connective tissue disorders
    Recurrence of chronic back and/or shoulder problems 2/100 (2%) 0/100 (0%)

    Limitations/Caveats

    We did not compare yoga to an active control group; Fatigue and depressive symptoms were not used as part of the inclusion criteria. Accordingly, our data may underestimate yoga's potential benefit.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Janice Kiecolt-Glaser, Principal Investigator
    Organization Ohio State University Comprehensive Cancer Center
    Phone 614-293-3499
    Email Janice.Kiecolt-Glaser@osumc.edu
    Responsible Party:
    Janice Kiecolt-Glaser, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00486525
    Other Study ID Numbers:
    • OSU-06137
    • NCI-2012-00564
    • R01CA126857
    • NCT00526526
    First Posted:
    Jun 14, 2007
    Last Update Posted:
    May 5, 2014
    Last Verified:
    Apr 1, 2014