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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149747
First Posted: September 8, 2005
Last Update Posted: May 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Abby C King, Stanford University
  Purpose
This study will evaluate the effect of regular aerobic exercise on improving sleep in older adults with moderate difficulty sleeping.

Condition Intervention Phase
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Behavioral: Moderate-Intensity Aerobic Physical Activity Behavioral: Health Education Class Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promoting Exercise, Sleep and Well-Being in Older Adults

Resource links provided by NLM:


Further study details as provided by Abby C King, Stanford University:

Primary Outcome Measures:
  • % 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 Outcome Measures:
  • 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.


  • Peak Exercise Oxygen Consumption [ Time Frame: 12 months ]
    Peak oxygen consumption measured during symptom limited treadmill exercise stress test


Enrollment: 66
Study Start Date: August 1999
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise training
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.
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
Other Name: Comprehensive fitness class
Placebo Comparator: 2
Attention-control of exposure to study staff. Weekly general health education classes conducted in group sessions.
Behavioral: Health Education Class
2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
Other Name: Healthy Aging Workshops

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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149747


Locations
United States, California
Stanford Prevention Research Center
Stanford, California, United States, 94305-5705
Sponsors and Collaborators
Stanford University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Abby C King, PhD Stanford University
  More Information

Publications:
Responsible Party: Abby C King, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00149747     History of Changes
Other Study ID Numbers: R01MH058853 ( U.S. NIH Grant/Contract )
DAHBR HB-C
First Submitted: September 6, 2005
First Posted: September 8, 2005
Results First Submitted: June 18, 2013
Results First Posted: May 1, 2014
Last Update Posted: May 24, 2016
Last Verified: April 2016

Keywords provided by Abby C King, Stanford University:
Sleep
Exercise
Older Adults

Additional relevant MeSH terms:
Disease
Sleep Wake Disorders
Parasomnias
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Dyssomnias