RTC: The Effectiveness of Regular Exercise on Improving Sleep in Older Adults

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00149747
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 66
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

This study will evaluate the effect of regular aerobic exercise on improving sleep in older adults with moderate difficulty sleeping.

Condition or Disease	Intervention/Treatment	Phase
Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic	Behavioral: Moderate-Intensity Aerobic Physical Activity; Behavioral: Health Education Class	Phase 2/Phase 3

Detailed Description

Sleep deprivation is a common problem among older adults. It is often at the root of increased mortality and some psychiatric disorders. Regular participation in a medium-intensity exercise regimen may help people sleep better. This study will assess the effectiveness of a regular exercise program on improving sleep in older adults with moderate difficulty sleeping.

Participants will be randomly assigned to one of two conditions. One group will partake in a moderate-intensity physical activity training regimen. The other group will act as a non-exercise attention-control comparison group. Each group will undergo its assigned treatment for 12 months. Sleep quantity and quality will be measured objectively using in-home polysomnography. Subjective sleep quality and health-related quality of life measures will be evaluated with questionnaires. All measurements will be performed at the beginning of the study, Month 6, and Month 12.

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Promoting Exercise, Sleep and Well-Being in Older Adults
• Study Start Date: Aug 1, 1999
• Actual Primary Completion Date: Sep 1, 2003
• Actual Study Completion Date: Sep 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise training Group based exercise training. Two weekly classes including aerobic endurance physical activity and strength and flexibility training, and up to three home-based sessions of similar composition of aerobic endurance, strength and flexibility training.	Behavioral: Moderate-Intensity Aerobic Physical Activity; Moderate-Intensity Aerobic Physical Activity. 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity; Other Names: Comprehensive fitness class
Placebo Comparator: 2 Attention-control of exposure to study staff. Weekly general health education classes conducted in group sessions.	Behavioral: Health Education Class; 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity; Other Names: Healthy Aging Workshops

Outcome Measures

Primary Outcome Measures

1. % Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline [baseline, 12 months]

   Percent of total sleep time spent in Stage 2 sleep at 12 months after adjusting for baseline level of Stage 2 sleep (i.e., baseline value included as a covariate in regression models conducted).

Secondary Outcome Measures

1. Sleep Disturbances [12 months]

   Self-reported sleep disturbance subscale on Pittsburgh Sleep Quality Index Subscale consists of 9 items scored on a range of 0 to 3, 0 indicating no disturbance and 3 indicating frequent disturbance. All 9 items are summed, and the summary scores is captured by 1 of 4 categories ranging from 0 to 3, with 0 indicating less frequent disturbances and 3 indicating greater frequency of disturbances.

2. Peak Exercise Oxygen Consumption [12 months]

   Peak oxygen consumption measured during symptom limited treadmill exercise stress test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Moderate difficulty sleeping unrelated to a physical illness or psychopathology (determined by the Sleep Questionnaire and Assessment of Wakefulness)

• Currently not physically active on a regular basis

• Body mass index less than 38

Exclusion Criteria:

• Currently physically active on a regular basis

• Diagnosed with a clinically significant sleep disorder

• Mild or no sleep complaints (determined by the Sleep Questionnaire and Assessment of Wakefulness)

• Unstable on medications

• Current smoker

• Consumes more than three alcoholic beverages per day

• Medical condition that may limit participation in moderate-intensity exercise

• Diagnosed with clinical psychopathology

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Prevention Research Center	Stanford	California	United States	94305-5705

Sponsors and Collaborators

• Stanford University
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Abby C King, PhD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bliwise DL, King AC, Harris RB, Haskell WL. Prevalence of self-reported poor sleep in a healthy population aged 50-65. Soc Sci Med. 1992 Jan;34(1):49-55.
• King AC, Oman RF, Brassington GS, Bliwise DL, Haskell WL. Moderate-intensity exercise and self-rated quality of sleep in older adults. A randomized controlled trial. JAMA. 1997 Jan 1;277(1):32-7.

• Responsible Party: Abby C King, Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT00149747
• Other Study ID Numbers: R01MH058853; R01MH058853; DAHBR HB-C
• First Posted: Sep 8, 2005
• Last Update Posted: May 24, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Abby C King, Professor, Stanford University: Sleep; Exercise; Older Adults
• Additional relevant MeSH terms: Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Disease

Study Results

Participant Flow

Recruitment Details	Participants recruited through radio and newspaper advertisement, direct mailings to local addresses.
Pre-assignment Detail	Overnight pulse oximetry for 1 night to rule out sleep apnea

Arm/Group Title	Exercise Group	Attention-Control (Health Education) Group
Arm/Group Description	Regular, aerobic endurance physical activity Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity	Weekly general health education classes Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
Period Title: Overall Study
STARTED	36	30
COMPLETED	32	27
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Exercise Group	Attention-Control (Health Education) Group	Total
Arm/Group Description	Regular, aerobic endurance physical activity Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity	Weekly general health education classes Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity	Total of all reporting groups
Overall Participants	36	30	66
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	36 100%	30 100%	66 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	24 66.7%	20 66.7%	44 66.7%
Male	12 33.3%	10 33.3%	22 33.3%

Outcome Measures

1. Primary Outcome

Title	% Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline
Description	Percent of total sleep time spent in Stage 2 sleep at 12 months after adjusting for baseline level of Stage 2 sleep (i.e., baseline value included as a covariate in regression models conducted).
Time Frame	baseline, 12 months

Outcome Measure Data

Analysis Population Description

Intent to Treat

Arm/Group Title	Exercise Group	Attention-Control (Health Education) Group
Arm/Group Description	Regular, aerobic endurance physical activity Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity	Weekly general health education classes Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
Measure Participants	35	30
Mean (Standard Deviation) [percentage of sleep time]	53.7 (9.6)	51.0 (9.8)

2. Secondary Outcome

Title	Sleep Disturbances
Description	Self-reported sleep disturbance subscale on Pittsburgh Sleep Quality Index Subscale consists of 9 items scored on a range of 0 to 3, 0 indicating no disturbance and 3 indicating frequent disturbance. All 9 items are summed, and the summary scores is captured by 1 of 4 categories ranging from 0 to 3, with 0 indicating less frequent disturbances and 3 indicating greater frequency of disturbances.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	Exercise Group	Attention-Control (Health Education) Group
Arm/Group Description	Regular, aerobic endurance physical activity Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity	Weekly general health education classes Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
Measure Participants	35	30
Mean (Standard Deviation) [units on a scale]	1.3 (.47)	1.6 (.5)

3. Secondary Outcome

Title	Peak Exercise Oxygen Consumption
Description	Peak oxygen consumption measured during symptom limited treadmill exercise stress test
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise Group	Attention-Control (Health Education) Group
Arm/Group Description	Regular, aerobic endurance physical activity Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity	Weekly general health education classes Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
Measure Participants	35	30
Mean (Standard Deviation) [mL of 02 per Kg per minute]	24.7 (2.2)	23.1 (2.3)

Adverse Events

Time Frame	Adverse events were collected over a 4-year period
Adverse Event Reporting Description	Adverse events were collected by blinded study staff during scheduled clinical measurements (baseline, 6month and 12 month)
Arm/Group Title	Exercise Group		Attention-Control (Health Education) Group
Arm/Group Description	Regular, aerobic endurance physical activity Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity		Weekly general health education classes Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
All Cause Mortality
	Exercise Group		Attention-Control (Health Education) Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Exercise Group		Attention-Control (Health Education) Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Exercise Group		Attention-Control (Health Education) Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

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.