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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cynthia Marie Castro, Stanford University
ClinicalTrials.gov Identifier:
NCT00149747
First received: September 6, 2005
Last updated: April 1, 2014
Last verified: April 2014
  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:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • % Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]
    Percent of total sleep time spent in Stage 2 sleep at 12 months after adjusting for baseline level of Stage 2 sleep.


Secondary Outcome Measures:
  • Sleep Disturbances [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Stanford University
Investigators
Principal Investigator: Abby C King, PhD Stanford University
  More Information

Additional Information:
Publications:
Responsible Party: Cynthia Marie Castro, Senior Research Scholar, Stanford University
ClinicalTrials.gov Identifier: NCT00149747     History of Changes
Other Study ID Numbers: R01 MH58853, R01MH058853, DAHBR HB-C
Study First Received: September 6, 2005
Results First Received: June 18, 2013
Last Updated: April 1, 2014
Health Authority: United States: Federal Government

Keywords provided by Stanford University:
Sleep
Exercise
Older Adults

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

ClinicalTrials.gov processed this record on October 19, 2014