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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00149747
First received: September 6, 2005
Last updated: January 6, 2009
Last verified: February 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promoting Exercise, Sleep and Well-Being in Older Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Total wake time at night, wake time after sleep onset, sleep latency, and percent of total sleep in stages 1, 2, 3, 4 and rapid eye movement as measured by in-home polysomnography collected at baseline, 6 months, and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective sleep quality, sleep duration, and sleep-onset latency as measured by the Pittsburgh Sleep Quality Index; [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Physical performance as measured by symptom-limited treadmill exercise testing; all measures collected at baseline, 6 months, and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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: 1
Regular, aerobic endurance physical activity
 Behavioral: 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
Weekly general health education classes
 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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149747

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

Additional Information:
Click here for a description of the study.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Abby C. King, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00149747     History of Changes
Other Study ID Numbers: R01 MH58853, DAHBR HB-C
Study First Received: September 6, 2005
Last Updated: January 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Sleep
Exercise
Older Adults

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

ClinicalTrials.gov processed this record on May 23, 2013