Clinical trial · Interventional
Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dementia, Mild | — | UNRESOLVED | — |
| Mild Cognitive Impairment | — | UNRESOLVED | — |
| Mobility Limitation | — | UNRESOLVED | — |
| Osteo Arthritis Knee | — | UNRESOLVED | — |
| Pain, Chronic | — | UNRESOLVED | — |
| Physical Disability | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tailored Physical Activity Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tailored Physical Activity Program for Pain
- description
- Specific characteristics of the intervention delivered in Phase 2 will be based on the information gathered from stakeholders in Phase 1.
- interventionNames
- Behavioral: Tailored Physical Activity Program
Primary outcomes (4)
- measure
- Program parameters
- timeFrame
- Day 1
- description
- Qualitative interviews to determine preferred program parameters.
- measure
- Program parameters
- timeFrame
- Day 1
- description
- Focus groups of clinicians to determine preferred program parameters.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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
References
Publications (89)
- BACKGROUNDInnes 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. PMID 32333589
- BACKGROUNDHunt LJ, Covinsky KE, Yaffe K, Stephens CE, Miao Y, Boscardin WJ, Smith AK. Pain in Community-Dwelling Older Adults with Dementia: Results from the National Health and Aging Trends Study. J Am Geriatr Soc. 2015 Aug;63(8):1503-11. doi: 10.1111/jgs.13536. Epub 2015 Jul 22. PMID 26200445
- BACKGROUNDSverdrup K, Bergh S, Selbaek G, Benth JS, Roen IM, Husebo B, Tangen GG. Trajectories of physical performance in nursing home residents with dementia. Aging Clin Exp Res. 2020 Dec;32(12):2603-2610. doi: 10.1007/s40520-020-01499-y. Epub 2020 Feb 14. PMID 32060802
- BACKGROUNDTanaka H, Nagata Y, Ishimaru D, Ogawa Y, Fukuhara K, Nishikawa T. Clinical factors associated with activities of daily living and their decline in patients with severe dementia. Psychogeriatrics. 2020 May;20(3):327-336. doi: 10.1111/psyg.12502. Epub 2019 Dec 28. PMID 31883310
- BACKGROUNDAPTA Geriatrics Combined Sections Meeting 2022 Poster Abstracts. J Geriatr Phys Ther. 2022 Jan-Mar 01;45(1):E16-E77. doi: 10.1519/JPT.0000000000000336. No abstract available. PMID 34928240
- BACKGROUNDGitlin LN, Arthur P, Piersol C, Hessels V, Wu SS, Dai Y, Mann WC. Targeting Behavioral Symptoms and Functional Decline in Dementia: A Randomized Clinical Trial. J Am Geriatr Soc. 2018 Feb;66(2):339-345. doi: 10.1111/jgs.15194. Epub 2017 Nov 28. PMID 29192967
- BACKGROUNDWhitlock EL, Diaz-Ramirez LG, Glymour MM, Boscardin WJ, Covinsky KE, Smith AK. Association Between Persistent Pain and Memory Decline and Dementia in a Longitudinal Cohort of Elders. JAMA Intern Med. 2017 Aug 1;177(8):1146-1153. doi: 10.1001/jamainternmed.2017.1622.