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The Effectiveness of Regular Exercise on Improving Sleep in Older Adults (RTC)

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Stanford University

Status and phase

Completed
Phase 3
Phase 2

Conditions

Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic

Treatments

Behavioral: Health Education Class
Behavioral: Moderate-Intensity Aerobic Physical Activity

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00149747
DAHBR HB-C
R01MH058853 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

66 patients

Sex

All

Ages

55+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

66 participants in 2 patient groups, including a placebo group

Exercise training
Experimental group
Description:
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.
Treatment:
Behavioral: Moderate-Intensity Aerobic Physical Activity
2
Placebo Comparator group
Description:
Attention-control of exposure to study staff. Weekly general health education classes conducted in group sessions.
Treatment:
Behavioral: Health Education Class

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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