Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Drexel University
Study ID
NCT06264362
Status
Not Yet Recruiting

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Conditions

  • Dementia, Mild
  • Mild Cognitive Impairment
  • Mobility Limitation
  • Osteo Arthritis Knee
  • Pain, Chronic
  • Physical Disability

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tailored Physical Activity Program — BEHAVIORAL
    Adaptation of physical activity as an intervention for pain management using the 3-Step Tailored Approach: assessing in Step 1 the Person Living with Dementia (PLWD), in Step 2 the Environment, and in Step 3 the Caregiver. With this approach, traditional exercises can be adapted to 1) functional activities (e.g., stair climbing) that are tailored to the interests (e.g., dancing, boxing) and preserved abilities of PLWD; 2) preferred and well-tolerated environments (e.g., home); and 3) account for extent and type of interventionist and caregiver involvement.

Study Details

The purpose of this study is to develop an exercise treatment program for knee osteoarthritis that works well for people with memory problems. This study will include two parts. Participants can choose to participate in either or both parts. In Part 1 (not a clinical trial) - The investigators are inviting the following people to participate in an interview: 1. Individuals aged 60 years or older who do not live in a nursing home and have both memory issues and knee pain. 2. Care partners of people with knee pain and memory issues. A care partner can be a family member or friend who helps regularly. 3. Clinicians (exercise physiologists or rehabilitation therapists like physical and occupational therapists) who have worked with older adults with memory issues and knee pain. The goal of these interviews is to learn from the experiences of people with memory issues and knee pain and those who care for them. From these interviews, the investigators hope to design a non-drug, tailored physical activity program that will be interesting and helpful in managing knee pain for older adults with memory problems. For people with memory problems and knee pain and their care partners: The investigators will ask some questions to determine eligibility to participate in the study. Those who qualify for the study will be invited to participate in an interview that could be completed online or in person (Philadelphia, PA). The interview could last up to 90 minutes (1 and a half hours) and can be completed as one or multiple sessions. For clinicians: Participants will engage in a 90-minute focus group with other clinicians where lunch will be served if in person. Those participating in an online focus group will receive a gift card equal to the value of lunch. In Part 2 (a clinical trial) - The program developed in Part 1 will be tested. The program will be physical activity-based. Specific program details for part 2 will be provided as they emerge. Participants can choose to sign up for either or both parts. Signing up for Part 1 does not mean participants have to sign up for Part 2. Please contact us for any questions.

Key Dates

Start date
Jun 2, 2025
Status verified
Mar 2025
Primary completion
Mar 31, 2027
Completion
May 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tailored Physical Activity Program for Pain
    Specific characteristics of the intervention delivered in Phase 2 will be based on the information gathered from stakeholders in Phase 1.

Primary Outcome Measure

Program parameters [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Drexel UniversityPhiladelphiaPennsylvania19104
Annalisa Na, PT, PhD
[email protected]
267-359-5889
Ben Senderling, MS
[email protected]
2673595655

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By research site
Drexel University· Philadelphia, PA

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