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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AG081547-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored Physical Activity Program for Pain | Experimental | Specific characteristics of the intervention delivered in Phase 2 will be based on the information gathered from stakeholders in Phase 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Program parameters | Qualitative interviews to determine preferred program parameters. | Day 1 |
| Program parameters | Focus groups of clinicians to determine preferred program parameters. | Day 1 |
| Feasibility of Intervention Measure | 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. | At study completion, an average of 8 weeks |
| Perception of program | Qualitative Interview of all who participated in the program to determine components of the intervention prototype that needs revising | At study completion, an average of 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Score | A self-reported pain measurement ranging from 0 (no pain) to 10 (worst pain). A high score indicates more pain. | Through study completion, an average of 8 weeks. |
| Zarit Burden Interview-Short Form |
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Inclusion Criteria for people living with dementia:
Exclusion Criteria for people living with dementia:
For care partners:
For clinicians:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annalisa Na, PT, PhD | Contact | 2673595889 | an838@drexel.edu | |
| Ben Senderling | Contact | 2673595655 | bms322@drexel.edu |
| Name | Affiliation | Role |
|---|---|---|
| Annalisa Na, PT, PhD | Drexel University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drexel University | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32333589 | Background | Innes KE, Sambamoorthi U. The Association of Osteoarthritis and Related Pain Burden to Incident Alzheimer's Disease and Related Dementias: A Retrospective Cohort Study of U.S. Medicare Beneficiaries. J Alzheimers Dis. 2020;75(3):789-805. doi: 10.3233/JAD-191311. | |
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In Phase 1 (not a clinical trial), 15 dyads and 15 clinicians will be interviewed (a dyad equals one person living with mild to very mild dementia and their care partner) to inform design of the intervention. In Phase 2 (a clinical trial), 20 people living with mild to very mild dementia will be treated with the new intervention. Their care partners may be involved in treatment.
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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.
| At study completion, an average of 8 weeks |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D003704 | Dementia |
| D008224 | Lymphoma, Follicular |
| D051346 | Mobility Limitation |
| D060825 | Cognitive Dysfunction |
| D010146 | Pain |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D003072 | Cognition Disorders |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided