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NCT03959202 · ClinicalTrials.gov registry record · Phase 1
A Personalized Behavioral Intervention to Improve Physical Activity, Sleep and Cognition in Sedentary Older Adults
A Phase 1 study of Sleep, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 129
- Enrollment target
- 1
- Study location
NCT03959202 is a Phase 1 study of Sleep that has completed, run by Johns Hopkins University. The registered enrollment target is 129 participants, below the 4,165-participant average among 151 other Sleep trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03959202, a Phase 1 study of Sleep, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 129 participants
- Enrollment target
- 1
- Study location
Study Summary
Cognitive decline and sleep complaints are prevalent in older adults and severely affect older adults' physical health and quality of life. Sedentary lifestyle, which is reported by 90% of older Americans, is an important risk factor for both cognitive decline and sleep disturbances. Although promoting physical activity has benefits to older adults' health, including sleep and cognition, traditional interventions to increase activity are challenging due to extensive staffing requirements and low adherence. Electronic activity monitors, such as wrist-worn accelerometers, can track heart rate, activity, and sleep to allow individuals to work towards personal activity and sleep goals. These appealing features make these devices ideal for interventions that aim to change behaviors and improve health outcomes. However, the efficacy of using electronic activity monitors to promote physical activity and health in older adults has not been examined. The investigators will conduct a randomized controlled trial in a cohort of older adults (without dementia) with both sedentary lifestyle and nocturnal sleep complaints to examine the effectiveness of a personalized behavioral intervention (compared to a control group) embedded within a smart watch application in older adults. 94 cognitively intact elders and 21 older adults with mild cognitive impairment will be enrolled and randomly allocated to the intervention or control group. Participants in the intervention arm will receive in person exercise training sessions, and personalized, self-monitor physical activity, receive interactive prompts, biweekly phone consultation with the research team, and financial incentives for achieving weekly physical activity goals. The control group will receive general education on physical activity in older adults and continue the routine daily activity during the intervention period. The intervention for older adults without cognitive impairment is 24 weeks and for older adults with mild co
Conditions Studied
Interventions
- OTHER Control
- BEHAVIORAL ELDERFITNESS
Study Locations (1)
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2019-07-11 |
| Est. Completion | 2023-02-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03959202
The ClinicalTrials.gov registry entry for NCT03959202 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,165-participant average among 151 other Sleep trials with a reported enrollment target (97% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Sleep appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.
NCT03959202 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03959202 about?
NCT03959202 is a clinical study titled "A Personalized Behavioral Intervention to Improve Physical Activity, Sleep and Cognition in Sedentary Older Adults". Cognitive decline and sleep complaints are prevalent in older adults and severely affect older adults' physical health and quality of life. Sedentary lifestyle, which is reported by 90% of older Americans, is an important risk factor for both cognitive decline and sleep disturbances. Although promot...
What is the current status of trial NCT03959202?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 129 participants. The study started on 2019-07-11. Estimated completion is 2023-02-28.
What conditions does trial NCT03959202 study?
This clinical trial studies the following conditions: Sleep.
What interventions are being tested in trial NCT03959202?
The interventions under investigation include: Control (OTHER), ELDERFITNESS (BEHAVIORAL).
Who is sponsoring clinical trial NCT03959202?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03959202 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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