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NCT02403752 · ClinicalTrials.gov registry record · NA
Paired Integrative Home Exercise for Seniors With Dementia and Their Caregivers (PairedPLIE)
A NA study of Dementia and Alzheimers Disease, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT02403752: Completed NA study of Dementia and Alzheimers Disease, sponsored by University of California, San Francisco.
NCT02403752 is a NA study of Dementia and Alzheimers Disease that has completed, run by University of California, San Francisco. The registered enrollment target is 20 participants, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02403752, a NA study of Dementia and Alzheimers Disease, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Specific Aim 1: To determine feasibility of a 20-minute dyadic exercise program for ambulatory individuals with dementia and caregivers living at home based on recruitment, adherence and retention. Investigators will conduct a pilot randomized controlled trial (RCT) with 20 dyads (total N = 40) in groups of 5 randomized to 16-week group exercise classes and regular home practice or wait list in a cross-over design. Investigators will assess feasibility of enrollment and retention, the proportion of completed outcome measures, and adherence by class attendance logs, caregiver-reported home practice logs and qualitative interviews to assess ease of implementation in the home environment. Investigators will explore feasibility of weekly phone calls to (potentially overwhelmed) caregivers and Fit-bit accelerometers as a measure for tracking home practice. Specific Aim 2: To collect preliminary effect size data for sample size calculation for a larger trial. Investigators will assess standard outcomes (such as the Short Physical Performance Battery and Alzheimer's Disease Assessment Scale - cognitive subscale as primary outcomes for affected individuals; and Caregiver Burden Inventory for caregivers) commonly used in pharmacological studies of individuals with dementia at baseline, 16 and 32 weeks and calculate effect sizes (Cohen's d) for between-group differences in outcome changes in the 20 dyads of the RCT described in Specific Aim 1. Specific Aim 3: To explore the feasibility of using non-invasive Near-Infrared Spectroscopy (NIRS) to assess regional cortical brain oxygenation and its sensitivity to change. Investigators will compare brain oxygenation variations before and after the exercise intervention during a memory task for the seniors with dementia.
Primary Outcome
We will perform a variety of standard measures in all participants and caregivers. Assessments will occur at baseline, after the 4 months of intervention, and at 8 months after follow-up of 4 months. Outcomes will primarily be utilized to assess feasibility and logistics of data collection procedures.
Conditions Studied
Interventions
- BEHAVIORAL Paired PLIE Program
Study Locations (1)
California
- UCaliforniaSF - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-03 |
| Est. Completion | 2018-07 |
| Phase | NA |
What the finished NCT02403752 record still lists
NCT02403752 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Dementia appearing as the primary indexed condition, and to 1 intervention - of which Paired PLIE Program is the first listed.
NCT02403752 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02403752 about?
NCT02403752 is a clinical study titled "Paired Integrative Home Exercise for Seniors With Dementia and Their Caregivers (PairedPLIE)". Specific Aim 1: To determine feasibility of a 20-minute dyadic exercise program for ambulatory individuals with dementia and caregivers living at home based on recruitment, adherence and retention. Investigators will conduct a pilot randomized controlled trial (RCT) with 20 dyads (total N = 40) in g...
What is the current status of trial NCT02403752?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2015-03. Estimated completion is 2018-07.
What conditions does trial NCT02403752 study?
This clinical trial studies the following conditions: Dementia, Alzheimers Disease.
What interventions are being tested in trial NCT02403752?
The interventions under investigation include: Paired PLIE Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT02403752?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02403752 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dementia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02403752's enrollment target sits among peer trials
20 180th of 199 higher than 12 of 199 other Dementia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dementia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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