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NCT Number: NCT06264362

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

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.

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Key information

Conditions

Pain, Chronic Arthritis Brain Diseases Central Nervous System Diseases Chronic Pain Cognition Disorders Cognitive Dysfunction Dementia Dementia, Mild Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Joint Diseases Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Mild Cognitive Impairment Mobility Limitation Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Osteo Arthritis Knee Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Physical Disability Rheumatic Diseases Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Chronic musculoskeletal pain, specifically osteoarthritis (OA) of the knee, is common among community-dwelling people living with memory issues and associated with cascading negative consequences on physical function limitations, quality of life decline, and caregiver burden; however, few beneficial and appropriate treatment options exist. This study seeks to use evidence, theory, and stakeholder input to design an exercise-based intervention for knee OA pain management tailored to the interests, preserved abilities, and biopsychosocial-environmental needs of community-dwelling older adults with mild to very mild dementia. Findings from K23 research will yield a nonpharmacological intervention prototype and delivery parameters that will inform a future efficacy study and have a strong potential for preserving or improving the quality of life of community-dwelling older adults with dementia and OA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for people living with dementia:

  • Age 60 or older
  • Speaks English
  • Mild/Very Mild dementia
  • Knee pain lasting ≥ 3 months, potentially related to arthritis
  • Knee pain is at least 2 out of 10 on average.

Exclusion criteria

for people living with dementia:

  • Reside in long term care facility
  • Unable or unwilling to consent
  • Has a condition with a life expectancy of less than 1-year
  • No care partner who is also willing to participate
  • Recent changes to pain or psychotropic medications in the last 60 days
  • Recent knee surgery in the last 1-year
  • Has a condition that contraindicates exercise (Phase 2 only)
  • Currently receiving rehab services (Phase 2 only)

For care partners:

  • No sex, gender, or age criteria
  • Has known person living with dementia ≥ 1 year
  • Speaks English
  • Able and willing to consent, including being recorded

For clinicians:

  • No sex, gender, or age criteria
  • Speaks English
  • Has ≥ 2 years of experience working with community-dwelling people with dementia and pain
  • Able and willing to consent, including being recorded

Treatment and study plan

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.

Primary outcomes

  1. Program parameters

    Time frame: Day 1

    Qualitative interviews to determine preferred program parameters.

  2. Program parameters

    Time frame: Day 1

    Focus groups of clinicians to determine preferred program parameters.

  3. Feasibility of Intervention Measure

    Time frame: At study completion, an average of 8 weeks

    The Feasibility of Intervention Measure is a standardized 4-question self-reported outcome measure to assess feasibility. Each item is scored on a 5-point scale, where 1 = completely disagree, 2 = disagree, 3 = neither agree or disagree, 4 = agree, 5 = completely agree. The responses are summed and range between 5 to 20, with higher scores indicating greater feasibility. A score of 16 or greater suggests the program is feasible, 15 to 9 indicates the program may be feasible, and a score of 8 or less suggests the program is not feasible.

  4. Perception of program

    Time frame: At study completion, an average of 8 weeks

    Qualitative Interview of all who participated in the program to determine components of the intervention prototype that needs revising

Secondary outcomes

  1. Numeric Pain Score

    Time frame: Through study completion, an average of 8 weeks.

    A self-reported pain measurement ranging from 0 (no pain) to 10 (worst pain). A high score indicates more pain.

  2. Zarit Burden Interview-Short Form

    Time frame: At study completion, an average of 8 weeks

    Zarit Burden Interview-Short Form is a12-item questionnaire to assess the burden of caregiving using a 5-point scale where 0 (never) to 4 (almost always). Scores are summed, ranging from 0-48, where a higher score indicates a greater caregiver burden.

Study contacts

Contact information is provided by the study sponsor or research team.

Annalisa Na, PT, PhD

CONTACT

[email protected]

2673595889

Ben Senderling

CONTACT

[email protected]

2673595655

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2024
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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