Sleep Disorders, Intrinsic, Sleep Initiation and Maintenance Disorders
Conditions
Keywords
Sleep, Exercise, 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.
Interventions
BEHAVIORALModerate-Intensity Aerobic Physical Activity
Moderate-Intensity Aerobic Physical Activity. 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity
BEHAVIORALHealth Education Class
2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
Sponsors
National Institute of Mental Health (NIMH)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline | baseline, 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Sleep Disturbances | 12 months | 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 | 12 months | Peak oxygen consumption measured during symptom limited treadmill exercise stress test |
Countries
United States
Participant flow
Recruitment details
Participants recruited through radio and newspaper advertisement, direct mailings to local addresses.
Pre-assignment details
Overnight pulse oximetry for 1 night to rule out sleep apnea
Participants by arm
| Arm | Count |
|---|---|
| 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 | 36 |
| 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 | 30 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Exercise Group | Attention-Control (Health Education) Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 30 Participants | 66 Participants |
| Sex: Female, Male Female | 24 Participants | 20 Participants | 44 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 0 / 30 |
| serious Total, serious adverse events | 0 / 36 | 0 / 30 |
Outcome results
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).
Time frame: baseline, 12 months
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Group | % Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline | 53.7 percentage of sleep time | Standard Deviation 9.6 |
| Attention-Control (Health Education) Group | % Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline | 51.0 percentage of sleep time | Standard Deviation 9.8 |
Secondary
Peak Exercise Oxygen Consumption
Peak oxygen consumption measured during symptom limited treadmill exercise stress test
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Group | Peak Exercise Oxygen Consumption | 24.7 mL of 02 per Kg per minute | Standard Deviation 2.2 |
| Attention-Control (Health Education) Group | Peak Exercise Oxygen Consumption | 23.1 mL of 02 per Kg per minute | Standard Deviation 2.3 |
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.
Time frame: 12 months
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Group | Sleep Disturbances | 1.3 units on a scale | Standard Deviation 0.47 |
| Attention-Control (Health Education) Group | Sleep Disturbances | 1.6 units on a scale | Standard Deviation 0.5 |