The Effectiveness of Regular Exercise on Improving Sleep in Older Adults - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 6, 2005

Last Updated Date

January 6, 2009

Start Date ^†

August 1999

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00149747 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Subjective sleep quality, sleep duration, and sleep-onset latency as measured by the Pittsburgh Sleep Quality Index;
Physical performance as measured by symptom-limited treadmill exercise testing; all measures collected at baseline, 6 months, and 12 months

Descriptive Information

Brief Title ^†

The Effectiveness of Regular Exercise on Improving Sleep in Older Adults

Official Title ^†

Promoting Exercise, Sleep and Well-Being in Older Adults

Brief Summary

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

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.

Study Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic

Intervention ^†

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

Study Arms / Comparison Groups

Experimental: Regular, aerobic endurance physical activity
Placebo Comparator: Weekly general health education classes

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

September 2003

Primary Completion Date

September 2003 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

55 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00149747

Responsible Party

Abby C. King, Principal Investigator, Stanford University

Secondary IDs ^††

DAHBR HB-C

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:

Abby C King, PhD

Stanford University

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

February 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.