At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 66 enrolled
Drug / intervention
Moderate-Intensity Aerobic Physical Activity +1 morebehavioral
Likely dose
Moderate-intensity aerobic physical activity 4+ days per week, 60+ minutes per dayAI-extracted
Key inclusion· 3
- ✓Moderate difficulty sleeping, unrelated to physical illness or psychopathology
- ✓Not currently physically active on a regular basis
- ✓BMI less than 38
Key exclusion· 7
- ✕Diagnosed with a clinically significant sleep disorder
- ✕Mild or no sleep complaints
- ✕Unstable on medications
- ✕Current smoker
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Promoting Exercise, Sleep and Well-Being in Older Adults
In Brief
A Phase 3 clinical trial evaluating Moderate-Intensity Aerobic Physical Activity and Health Education Class for Sleep Initiation and Maintenance Disorders and Sleep Disorders, Intrinsic. Completed, enrolled 66 participants across 1 site.
Detailed Summary
This study will evaluate the effect of regular aerobic exercise on improving sleep in older adults with moderate difficulty sleeping.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)
Timeline
Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 1999
Primary CompletionSep 2003
First PostedSep 2005
TodayJul 2026
First PostedSep 8, 2005
Enrollment StartAug 1, 1999
Primary CompletionSep 1, 2003
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.8 years ago
Interventions
Moderate-Intensity Aerobic Physical Activitybehavioral
Moderate-Intensity Aerobic Physical Activity. 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity
Health Education Classbehavioral
2 classes a week, 90+minutes per class, general health education, excluding information on physical activity