Clinical trial NCT00149747: The Effectiveness of Regular Exercise on Improving Sleep in Older Adults
Official title: Promoting Exercise, Sleep and Well-Being in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Keywords: Sleep
Exercise
Older Adults
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-08
Enrollment: 66
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: % Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline
timeFrame: baseline, 12 months
Secondary outcomes:
measure: Sleep Disturbances
timeFrame: 12 months
measure: Peak Exercise Oxygen Consumption
timeFrame: 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Prevention Research Center
state: California
Study officials:
affiliation: Stanford University
name: Abby C King, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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 Sci. 2008 Sep;63(9):997-1004. doi: 10.1093/gerona/63.9.997.