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

Primary Purpose

Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Moderate-Intensity Aerobic Physical Activity
Health Education Class
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring Sleep, Exercise, Older Adults

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Stanford Prevention Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Exercise training

2

Arm 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.

Attention-control of exposure to study staff. Weekly general health education classes conducted in group sessions.

Outcomes

Primary Outcome Measures

% Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline
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
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
Peak oxygen consumption measured during symptom limited treadmill exercise stress test

Full Information

First Posted
September 6, 2005
Last Updated
April 25, 2016
Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00149747
Brief Title
The Effectiveness of Regular Exercise on Improving Sleep in Older Adults
Acronym
RTC
Official Title
Promoting Exercise, Sleep and Well-Being in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic
Keywords
Sleep, Exercise, Older Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training
Arm Type
Experimental
Arm 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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Attention-control of exposure to study staff. Weekly general health education classes conducted in group sessions.
Intervention Type
Behavioral
Intervention Name(s)
Moderate-Intensity Aerobic Physical Activity
Other Intervention Name(s)
Comprehensive fitness class
Intervention Description
Moderate-Intensity Aerobic Physical Activity. 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity
Intervention Type
Behavioral
Intervention Name(s)
Health Education Class
Other Intervention Name(s)
Healthy Aging Workshops
Intervention Description
2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
Primary Outcome Measure Information:
Title
% Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline
Description
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).
Time Frame
baseline, 12 months
Secondary Outcome Measure Information:
Title
Sleep Disturbances
Description
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.
Time Frame
12 months
Title
Peak Exercise Oxygen Consumption
Description
Peak oxygen consumption measured during symptom limited treadmill exercise stress test
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abby C King, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Prevention Research Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8980207
Citation
King AC, Oman RF, Brassington GS, Bliwise DL, Haskell WL. Moderate-intensity exercise and self-rated quality of sleep in older adults. A randomized controlled trial. JAMA. 1997 Jan 1;277(1):32-7.
Results Reference
background
PubMed Identifier
1738856
Citation
Bliwise DL, King AC, Harris RB, Haskell WL. Prevalence of self-reported poor sleep in a healthy population aged 50-65. Soc Sci Med. 1992 Jan;34(1):49-55. doi: 10.1016/0277-9536(92)90066-y.
Results Reference
background
PubMed Identifier
18840807
Citation
King AC, Pruitt LA, Woo S, Castro CM, Ahn DK, Vitiello MV, Woodward SH, Bliwise DL. Effects of moderate-intensity exercise on polysomnographic and subjective sleep quality in older adults with mild to moderate sleep complaints. J Gerontol A Biol Sci Med Sci. 2008 Sep;63(9):997-1004. doi: 10.1093/gerona/63.9.997.
Results Reference
result

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The Effectiveness of Regular Exercise on Improving Sleep in Older Adults

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