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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH058853 | U.S. NIH Grant/Contract | View source | |
| DAHBR HB-C |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will evaluate the effect of regular aerobic exercise on improving sleep in older adults with moderate difficulty sleeping.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise training | Experimental | 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. |
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| 2 | Placebo Comparator | Attention-control of exposure to study staff. Weekly general health education classes conducted in group sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate-Intensity Aerobic Physical Activity | Behavioral | Moderate-Intensity Aerobic Physical Activity. 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity |
| Measure | Description | Time Frame |
|---|---|---|
| % 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). | baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abby C King, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Prevention Research Center | Stanford | California | 94305-5705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8980207 | Background | 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. | |
| 1738856 | Background | 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. |
| Label | URL |
|---|---|
| Click here for a description of the study. | View source |
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Overnight pulse oximetry for 1 night to rule out sleep apnea
Participants recruited through radio and newspaper advertisement, direct mailings to local addresses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Group | Regular, aerobic endurance physical activity Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity |
| FG001 | Attention-Control (Health Education) Group | Weekly general health education classes Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise Group | Regular, aerobic endurance physical activity Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity |
| BG001 | Attention-Control (Health Education) Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | % 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). | Intent to Treat | Posted | Mean | Standard Deviation | percentage of sleep time | baseline, 12 months |
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Adverse events were collected over a 4-year period
Adverse events were collected by blinded study staff during scheduled clinical measurements (baseline, 6month and 12 month)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise Group | Regular, aerobic endurance physical activity Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abby C. King | Stanford Prevention Research Center | 6507252826 | king@stanford.edu |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| Health Education Class | Behavioral | 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity |
|
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| 12 months |
| Peak Exercise Oxygen Consumption | Peak oxygen consumption measured during symptom limited treadmill exercise stress test | 12 months |
| 18840807 | Result | 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. |
Weekly general health education classes Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | 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. | Intent to treat | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| Secondary | Peak Exercise Oxygen Consumption | Peak oxygen consumption measured during symptom limited treadmill exercise stress test | Posted | Mean | Standard Deviation | mL of 02 per Kg per minute | 12 months |
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| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Attention-Control (Health Education) Group | Weekly general health education classes Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity | 0 | 30 | 0 | 30 |
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| D001519 |
| Behavior |