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Completed

NCT Number: NCT00149747

The Effectiveness of Regular Exercise on Improving Sleep in Older Adults

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

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Stanford Prevention Research Center

Stanford, California, 94305-5705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate-Intensity Aerobic Physical Activity

Behavioral

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

Other names: Comprehensive fitness class

Health Education Class

Behavioral

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

Other names: Healthy Aging Workshops

Primary outcomes

  1. % 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

  1. Sleep Disturbances

    Time frame: 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

    Time frame: 12 months

    Peak oxygen consumption measured during symptom limited treadmill exercise stress test

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Promoting Exercise, Sleep and Well-Being in Older Adults

Acronym: RTC

Important dates

Study start
1999
Primary completion
2003
Study completion
2003
First posted
Sep 8, 2005
Registry last updated
May 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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