Paired Integrative Home Exercise for Seniors With Dementia and Their Caregivers (PairedPLIE)

Completed · Not applicable

Conditions studied: Dementia, Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT02403752

Run by

University of California, San Francisco

People needed

20

Starts

2015-03-01

Expected to finish

2018-07-01

Last updated by the study team

2018-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Affected individuals: dementia diagnosis (any type, mild to moderate severity [defined as independent in at least 1 basic ADL])
• Ambulatory and able to take 2 steps without cane or walker
• Living in the community in a private home or apartment
• English language fluency.
• Caregiver/care partner: lives with affected individual
• Motivated to practice regularly (4-5 times per week) at home
• Able to answer study questions related to the affected individual's functional status, mood, behaviors, quality of life and their own feelings regarding caregiving
• English language fluency.

You may not qualify if…

• Affected Individuals: behavioral or physical issues that would be disruptive or dangerous to themselves or others (e.g., active psychosis, drug abuse, severe behavioral issues)
• Planning to move to a facility before the end of the study period
• Terminal illness (life expectancy < 1 year)
• Non-stable dementia medication dose
• Current participation in another research study.
• Caregiver/care partner: planning to place affected individual in an institutional setting during the study period
• Terminal illness (life expectancy < 1 year)
• Behavioral or physical issues that are disruptive or dangerous.

Where it is running

• UCaliforniaSF — San Francisco, California, United States

Full record on ClinicalTrials.gov

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