The Effectiveness of Regular Exercise on Improving Sleep in Older Adults

Sleep Initiation and Maintenance Disorders Clinical Trial

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Official title:

Promoting Exercise, Sleep and Well-Being in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149747
• Other study ID #: R01MH058853
• Secondary ID: R01MH058853DAHBR
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 6, 2005
• Last updated: December 8, 2015
• Start date: August 1999
• Est. completion date: September 2003

Study information

• Verified date: December 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Parasomnias
• Sleep Disorders
• Sleep Disorders, Intrinsic
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Stanford Prevention Research Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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 S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline	Percent of total sleep time spent in Stage 2 sleep at 12 months after adjusting for baseline level of Stage 2 sleep.	baseline, 12 months	No
Secondary	Sleep Disturbances	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.	12 months	No
Secondary	Peak Exercise Oxygen Consumption	Peak oxygen consumption measured during symptom limited treadmill exercise stress test	12 months	No