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Clinical Trials/NCT00149747
NCT00149747
Completed
Phase 2

Promoting Exercise, Sleep and Well-Being in Older Adults

Stanford University1 site in 1 country66 target enrollmentAugust 1999

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Sleep Initiation and Maintenance Disorders
Sponsor
Stanford University
Enrollment
66
Locations
1
Primary Endpoint
% Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1999
End Date
September 2003
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Abby C King

Professor

Stanford University

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

Outcomes

Primary Outcomes

% Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline

Time Frame: 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 Outcomes

  • Sleep Disturbances(12 months)
  • Peak Exercise Oxygen Consumption(12 months)

Study Sites (1)

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