Paired Integrative Home Exercise for Seniors With Dementia and Their Caregivers (PairedPLIE)
Public ClinicalTrials.gov record NCT02403752. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Paired Integrative Home Exercise for Seniors With Dementia and Their Caregivers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02403752
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2015
- Primary completion
- Jun 30, 2018
- Completion
- Jun 30, 2018
- Last update posted
- Dec 18, 2018
2015 – 2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCaliforniaSF | San Francisco | California | 94115 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02403752, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 18, 2018 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02403752 live on ClinicalTrials.gov.