TCPT: Tai Chi and Physical Therapy for Knee Osteoarthritis

• Sponsor: Tufts Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01258985
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 204
• Location: 1
• Arms: 2
• Duration (Months): 42.1
• Patients Per Site Per Month: 4.9

Study Details

Study Description

Brief Summary

We will conduct a large randomized controlled trial comparing the effectiveness and cost-effectiveness of Tai Chi mind-body exercise and standard-of-care Physical Therapy for Knee Osteoarthritis.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Behavioral: Tai Chi; Behavioral: Physical Therapy	N/A

Detailed Description

Osteoarthritis (OA) causes pain and long-term disability, and the public health impact will increase as the population ages. In addition to inconsistent effectiveness, current treatments such as nonsteroidal anti-inflammatory drugs, knee replacement, and physical therapy may be expensive, result in serious adverse effects, reduce physical function, and fail to improve mental well-being. Finding effective treatments to maintain function and quality of life in OA patients is one of the national priorities identified this year by the Institute of Medicine.

We propose to conduct the first comparative effectiveness and cost-effectiveness trial of Tai Chi vs. physical therapy (PT) in a large symptomatic Knee OA population. A single-blind, randomized, controlled trial of Tai Chi vs. Physical Therapy will be conducted in 180 patients who meet the American College of Rheumatology criteria for Knee OA. Patients will be randomized to 12 weeks of treatment with Tai Chi (2x/week) or Standard Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorous supervised home exercise) with 24 and 52 week follow-ups.

Study Design

• Study Type: Interventional
• Actual Enrollment: 204 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Tai Chi and Physical Therapy for Knee Osteoarthritis
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tai Chi 12 weeks of Tai Chi classes	Behavioral: Tai Chi; 12 weeks of Tai Chi
Active Comparator: Physical Therapy 6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise	Behavioral: Physical Therapy; 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

Outcome Measures

Primary Outcome Measures

1. Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks [From Week 0 to Week 12]

   The WOMAC (version: Visual Analog Scale 3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.

Secondary Outcome Measures

1. Change in Medical Outcomes Short Form-36 PCS [From Week 0, to Week 12, or to week 24, or to week 52]

   The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) is the summary score for the physical quality-of-life components (range, 0 to 100, with higher scores indicating better health status)

2. Change in 6 Minute Walk [From Week 0, to Week 12, or to week 24, or to week 52]

   The 6 minute Walk Test is a measure of functional exercise capacity. Participants are asked to walk as far as possible within a six-minute period, and the distance covered at the end is noted and recorded.

3. Change in 20 Meter Walk Test [From Week 0, to Week 12, or to week 24, or to week 52]

   the 20-meter walk test is a performance measurement of walking ability (measured as the total number of seconds it takes to walk 20 meters); lower scores indicate improved walking ability

4. Change in Patient Global VAS [From Week 0, to Week 12, or to week 24, or to week 52]

   Patients' global assessment score (Patient Global VAS) was assessed separately by the participant, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).

5. Change in Beck II Depression Inventory [From Week 0, to Week 12, or to week 24, or to week 52]

   Beck II Depression Inventory (BDI), second edition, is a 21-question, validated, self-report instrument that measures the severity of depressive symptoms. Total scores range from 0-63, and higher scores reflect greater depressive symptoms. BDI scores ranging from 0-13 represent minimal depressive symptoms; scores from 14-19 are mild; scores from 20-28 are moderate; and scores from 29-63 represent severe depressive symptoms.

6. Change in Arthritis Self-Efficacy Scale [From Week 0, to Week 12, or to week 24, or to week 52]

   The Arthritis Self-Efficacy Scale is a self-report score measuring self-efficacy with respect to arthritis (range, 1 to 10, with higher scores indicating greater self-efficacy).

7. Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS) [From Week 0, to Week 12, or to week 24, or to week 52]

   The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component Score (MCS) is the summary score for the mental quality-of-life components (range, 0 to 100, with higher scores indicating better health status)

8. Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function [From Week 0, to Week 12, or to week 24, or to week 52]

   The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.

9. Outcome Expectation Scale [Week 0]

   The Outcome Expectations for Exercise Scale (range, 1 to 5, with 1 indicating no expectations for exercise and 5 the highest expectations for exercise) is a self-report measure of outcome expectations for exercise.

10. Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale [From Week 0, to week 24 or to week 52]

    The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 40 years and older

• American College of Rheumatology criteria for symptomatic Knee OA: Pain on more than half the days of the past month during at least one of the following activities: walking, going up or down stairs, standing upright, or lying in bed at night;101 radiographic evidence of grade I-III tibiofemoral or patellofemoral OA: defined as the presence of osteophytes in the tibiofemoral compartment and /or the patellofemoral compartment, as assessed on standing anterior/posterior and lateral views101

• WOMAC pain subscale score >= 40 (visual analog version) on at least 1 of 5 questions (range 0 to 100 each)

• Clinical examination confirming knee pain or discomfort or instability referable to the knee joint

• Physically able to participate in both the Tai Chi and Standard PT programs

• Willing to undergo testing and intervention procedures and 1.willing to abstain from Tai Chi until completion of the program, if randomized to Standard PT regimen. 2. willing to abstain from Standard PT regimen until completion of the program, if randomized to Tai Chi

Exclusion Criteria:

• Prior experience with physical therapy, Tai Chi or other similar types of Complementary and Alternative Medicine in the past 1 year such as Qi gong and yoga since these share some of the principles of Tai Chi.

• Serious medical conditions limiting the ability and safety to participate in either the Tai Chi or Standard PT regimen programs as determined by primary care physicians; these include dementia, neurological disease, symptomatic heart or vascular disease (angina, peripheral vascular disease, congestive heart failure), severe hypertension, recent stroke, severe insulin-dependent diabetes mellitus, psychiatric disease, renal disease, liver disease, active cancer and anemia

• Any intra-articular steroid injections in the previous 3 months or reconstructive surgery on the affected knee

• Any intra-articular Synvisc or Hyalgan injections in the previous 6 months

• Inability to pass the Mini-Mental Status examination (with a score below 24)102

• Inability to walk without a cane or other assistive device 100% of the time during the baseline assessments

• Enrollment in any other clinical trial within the last 30 days

• Plan to permanently relocate from the region during the trial period

• Positive pregnancy test or planning pregnancy within the study period

• Not English-Speaking

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts Medical Center	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

• Tufts Medical Center
• National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Chenchen Wang, MD, MSc, Tufts Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• Reid KF, Price LL, Harvey WF, Driban JB, Hau C, Fielding RA, Wang C. Muscle Power Is an Independent Determinant of Pain and Quality of Life in Knee Osteoarthritis. Arthritis Rheumatol. 2015 Dec;67(12):3166-73. doi: 10.1002/art.39336.
• Wang C, Collet JP, Lau J. The effect of Tai Chi on health outcomes in patients with chronic conditions: a systematic review. Arch Intern Med. 2004 Mar 8;164(5):493-501. Review.
• Wang C, Roubenoff R, Lau J, Kalish R, Schmid CH, Tighiouart H, Rones R, Hibberd PL. Effect of Tai Chi in adults with rheumatoid arthritis. Rheumatology (Oxford). 2005 May;44(5):685-7. Epub 2005 Mar 1.
• Wang C, Schmid CH, Hibberd PL, Kalish R, Roubenoff R, Rones R, McAlindon T. Tai Chi is effective in treating knee osteoarthritis: a randomized controlled trial. Arthritis Rheum. 2009 Nov 15;61(11):1545-53. doi: 10.1002/art.24832.
• Wang C, Schmid CH, Hibberd PL, Kalish R, Roubenoff R, Rones R, Okparavero A, McAlindon T. Tai Chi for treating knee osteoarthritis: designing a long-term follow up randomized controlled trial. BMC Musculoskelet Disord. 2008 Jul 29;9:108. doi: 10.1186/1471-2474-9-108.
• Wang C, Schmid CH, Rones R, Kalish R, Yinh J, Goldenberg DL, Lee Y, McAlindon T. A randomized trial of tai chi for fibromyalgia. N Engl J Med. 2010 Aug 19;363(8):743-54. doi: 10.1056/NEJMoa0912611.
• Wang C. Tai Chi improves pain and functional status in adults with rheumatoid arthritis: results of a pilot single-blinded randomized controlled trial. Med Sport Sci. 2008;52:218-229. doi: 10.1159/000134302.

• Responsible Party: Tufts Medical Center
• ClinicalTrials.gov Identifier: NCT01258985
• Other Study ID Numbers: 1R01AT005521-01A1; R01AT005521; UL1TR000073; UL1TR001064
• First Posted: Dec 13, 2010
• Last Update Posted: Aug 4, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Tufts Medical Center: Knee; Knee osteoarthritis; osteoarthritis; Knee pain; Tai Chi; Physical Therapy; mind-body exercise
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

Participant Flow

Arm/Group Title	Tai Chi	Physical Therapy
Arm/Group Description	12 weeks of Tai Chi classes Tai Chi: 12 weeks of Tai Chi	6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise
Period Title: Overall Study
STARTED	106	98
COMPLETED	106	98
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Tai Chi	Physical Therapy	Total
Arm/Group Description	12 weeks of Tai Chi classes Tai Chi: 12 weeks of Tai Chi	6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise	Total of all reporting groups
Overall Participants	106	98	204
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.3 (10.5)	60.1 (10.5)	60.2 (10.5)
Sex: Female, Male (Count of Participants)
Female	75 70.8%	68 69.4%	143 70.1%
Male	31 29.2%	30 30.6%	61 29.9%
Race/Ethnicity, Customized (participants) [Number]
White	54 50.9%	54 55.1%	108 52.9%
Black	41 38.7%	31 31.6%	72 35.3%
Asian	4 3.8%	2 2%	6 2.9%
Other	7 6.6%	11 11.2%	18 8.8%
Region of Enrollment (participants) [Number]
United States	106 100%	98 100%	204 100%

Outcome Measures

1. Primary Outcome

Title	Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks
Description	The WOMAC (version: Visual Analog Scale 3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.
Time Frame	From Week 0 to Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi	Physical Therapy
Arm/Group Description	12 weeks of Tai Chi classes Tai Chi: 12 weeks of Tai Chi	6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise
Measure Participants	106	98
Mean (95% Confidence Interval) [units on a scale]	-167.2	-143

2. Secondary Outcome

Title	Change in Medical Outcomes Short Form-36 PCS
Description	The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) is the summary score for the physical quality-of-life components (range, 0 to 100, with higher scores indicating better health status)
Time Frame	From Week 0, to Week 12, or to week 24, or to week 52

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi	Physical Therapy
Arm/Group Description	12 weeks of Tai Chi classes Tai Chi: 12 weeks of Tai Chi	6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise
Measure Participants	106	98
week 12	6.3	3.1
24 weeks	7.1	3.4
52 weeks	6.3	4.3

3. Secondary Outcome

Title	Change in 6 Minute Walk
Description	The 6 minute Walk Test is a measure of functional exercise capacity. Participants are asked to walk as far as possible within a six-minute period, and the distance covered at the end is noted and recorded.
Time Frame	From Week 0, to Week 12, or to week 24, or to week 52

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi	Physical Therapy
Arm/Group Description	12 weeks of Tai Chi classes Tai Chi: 12 weeks of Tai Chi	6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise
Measure Participants	106	98
Week 12	28.6	26.1
Week 24	28.9	24.5
Week 52	27.1	22.8

4. Secondary Outcome

Title	Change in 20 Meter Walk Test
Description	the 20-meter walk test is a performance measurement of walking ability (measured as the total number of seconds it takes to walk 20 meters); lower scores indicate improved walking ability
Time Frame	From Week 0, to Week 12, or to week 24, or to week 52

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi	Physical Therapy
Arm/Group Description	12 weeks of Tai Chi classes Tai Chi: 12 weeks of Tai Chi	6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise
Measure Participants	106	98
12 weeks	-1.6	-1.1
24 weeks	-2.4	-1.2
52 weeks	-2.4	-1.0

5. Secondary Outcome

Title	Change in Patient Global VAS
Description	Patients' global assessment score (Patient Global VAS) was assessed separately by the participant, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).
Time Frame	From Week 0, to Week 12, or to week 24, or to week 52

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi	Physical Therapy
Arm/Group Description	12 weeks of Tai Chi classes Tai Chi: 12 weeks of Tai Chi	6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise
Measure Participants	106	98
12 weeks	-0.3	-0.2
24 weeks	-2.4	-1.73
52 weeks	-1.84	-1.31

6. Secondary Outcome

Title	Change in Beck II Depression Inventory
Description	Beck II Depression Inventory (BDI), second edition, is a 21-question, validated, self-report instrument that measures the severity of depressive symptoms. Total scores range from 0-63, and higher scores reflect greater depressive symptoms. BDI scores ranging from 0-13 represent minimal depressive symptoms; scores from 14-19 are mild; scores from 20-28 are moderate; and scores from 29-63 represent severe depressive symptoms.
Time Frame	From Week 0, to Week 12, or to week 24, or to week 52

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi	Physical Therapy
Arm/Group Description	12 weeks of Tai Chi classes Tai Chi: 12 weeks of Tai Chi	6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise
Measure Participants	106	98
12 weeks	-2.2	0.5
24 weeks	-1.7	0.2
52 weeks	-1.1	-0.003

7. Secondary Outcome

Title	Change in Arthritis Self-Efficacy Scale
Description	The Arthritis Self-Efficacy Scale is a self-report score measuring self-efficacy with respect to arthritis (range, 1 to 10, with higher scores indicating greater self-efficacy).
Time Frame	From Week 0, to Week 12, or to week 24, or to week 52

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi	Physical Therapy
Arm/Group Description	12 weeks of Tai Chi classes Tai Chi: 12 weeks of Tai Chi	6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise
Measure Participants	106	98
12 weeks	1.3	0.8
24 weeks	0.9	0.9
52 weeks	1.0	0.7

8. Secondary Outcome

Title	Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS)
Description	The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component Score (MCS) is the summary score for the mental quality-of-life components (range, 0 to 100, with higher scores indicating better health status)
Time Frame	From Week 0, to Week 12, or to week 24, or to week 52

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi	Physical Therapy
Arm/Group Description	12 weeks of Tai Chi classes Tai Chi: 12 weeks of Tai Chi	6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise
Measure Participants	106	98
12 weeks	1.6	-0.03
24 weeks	0.4	-0.7
52 weeks	-0.1	-1.5

9. Secondary Outcome

Title	Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function
Description	The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.
Time Frame	From Week 0, to Week 12, or to week 24, or to week 52

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi	Physical Therapy
Arm/Group Description	12 weeks of Tai Chi classes Tai Chi: 12 weeks of Tai Chi	6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise
Measure Participants	106	98
12 weeks	-608.3	-114.1
24 weeks	-586.8	-455.7
52 weeks	-532.3	-444.0

10. Secondary Outcome

Title	Outcome Expectation Scale
Description	The Outcome Expectations for Exercise Scale (range, 1 to 5, with 1 indicating no expectations for exercise and 5 the highest expectations for exercise) is a self-report measure of outcome expectations for exercise.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi	Physical Therapy
Arm/Group Description	12 weeks of Tai Chi classes Tai Chi: 12 weeks of Tai Chi	6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise
Measure Participants	106	98
Mean (Standard Deviation) [units on a scale]	3.9 (0.5)	3.9 (0.6)

11. Secondary Outcome

Title	Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale
Description	The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.
Time Frame	From Week 0, to week 24 or to week 52

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi	Physical Therapy
Arm/Group Description	12 weeks of Tai Chi classes Tai Chi: 12 weeks of Tai Chi	6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise
Measure Participants	106	98
24 weeks	-158.6	-124.3
52 weeks	-138.8	-121.0

Adverse Events

Time Frame	12 weeks
Adverse Event Reporting Description	participants are monitored weekly during intervention for adverse events. All are recorded on a case report form and evaluated according to Institutional Review Board mandated criteria. No systematic ascertainment of adverse events is undertaken after the intervention period based on the principle that all would be unrelated to the intervention.
Arm/Group Title	Tai Chi		Physical Therapy
Arm/Group Description	12 weeks of Tai Chi classes Tai Chi: 12 weeks of Tai Chi		6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise
All Cause Mortality
	Tai Chi		Physical Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Tai Chi		Physical Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/106 (0%)		0/98 (0%)
Other (Not Including Serious) Adverse Events
	Tai Chi		Physical Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/106 (0%)		0/98 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.