The Effectiveness of Regular Exercise on Improving Sleep in Older Adults

NCT ID: NCT00149747

Last Updated: 2016-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-08-31
• Study Completion Date: 2003-09-30

Brief Summary

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

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.

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Moderate-Intensity Aerobic Physical Activity

Intervention Type: BEHAVIORAL

Moderate-Intensity Aerobic Physical Activity. 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity

2

Attention-control of exposure to study staff. Weekly general health education classes conducted in group sessions.

Group Type: PLACEBO_COMPARATOR

Health Education Class

Intervention Type: BEHAVIORAL

2 classes a week, 90+minutes per class, general health education, excluding information on physical activity

Interventions

Moderate-Intensity Aerobic Physical Activity

Moderate-Intensity Aerobic Physical Activity. 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity

Intervention Type: BEHAVIORAL

Health Education Class

2 classes a week, 90+minutes per class, general health education, excluding information on physical activity

Intervention Type: BEHAVIORAL

Other Intervention Names

Comprehensive fitness class; Healthy Aging Workshops

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Abby C King

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abby C King, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Prevention Research Center

Stanford, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 8980207 (View on PubMed)

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. doi: 10.1016/0277-9536(92)90066-y.

Reference Type: BACKGROUND

PMID: 1738856 (View on PubMed)

King AC, Pruitt LA, Woo S, Castro CM, Ahn DK, Vitiello MV, Woodward SH, Bliwise DL. Effects of moderate-intensity exercise on polysomnographic and subjective sleep quality in older adults with mild to moderate sleep complaints. J Gerontol A Biol Sci Med Sci. 2008 Sep;63(9):997-1004. doi: 10.1093/gerona/63.9.997.

Reference Type: RESULT

PMID: 18840807 (View on PubMed)

Other Identifiers

R01MH058853

Identifier Type: NIH

Identifier Source: secondary_id

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DAHBR HB-C

Identifier Type: -

Identifier Source: secondary_id

R01MH058853

Identifier Type: NIH

Identifier Source: org_study_id

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