40 Participants Needed

Physical Activity Program for Dementia and Chronic Pain

BS
AN
Overseen ByAnnalisa Na, PT, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Drexel University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you have had recent changes to pain or psychotropic medications in the last 60 days, you may not be eligible to participate.

What data supports the effectiveness of the treatment Tailored Physical Activity Program for dementia and chronic pain?

Research shows that physical activity can improve behavior and reduce pain in people with dementia. Studies have found that tailored exercise programs can enhance physical performance and increase activity levels in individuals with dementia, suggesting potential benefits for managing symptoms.12345

Is a physical activity program safe for people with dementia and chronic pain?

Research on exercise programs for people with dementia, including high-intensity functional exercises, shows they are generally safe, with attention to adverse events and individual health conditions. These programs are often well-tolerated, but it's important to monitor participants for any negative reactions.12367

How does the Tailored Physical Activity Program treatment differ from other treatments for dementia and chronic pain?

The Tailored Physical Activity Program is unique because it focuses on personalized exercise routines to improve physical activity, which can positively impact cognition and behavior in dementia patients. Unlike standard treatments that may not address physical inactivity, this program is designed to be adaptable to individual needs, enhancing engagement and enjoyment while potentially reducing pain and neuropsychiatric symptoms.12368

Research Team

AN

Annalisa Na, PT, PhD

Principal Investigator

Drexel University

Eligibility Criteria

This trial is for community-dwelling adults aged 60 or older with memory issues and knee pain, not living in nursing homes. It's also for their care partners and clinicians experienced with this demographic. Participants must be able to complete an interview about their experiences.

Inclusion Criteria

I am 60 years old or older.
I have been diagnosed with mild or very mild dementia.
Speaks English
See 2 more

Exclusion Criteria

I am currently in Phase 2 rehabilitation.
I do not have a care partner willing to join the study with me.
Has a condition that contraindicates exercise (Phase 2 only)
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person or virtual)

Treatment

Participants engage in a tailored physical activity program for knee osteoarthritis pain management

8 weeks
Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person or virtual)

Treatment Details

Interventions

  • Tailored Physical Activity Program
Trial OverviewThe study aims to create a tailored physical activity program specifically designed for older adults with both knee osteoarthritis and cognitive impairments. The effectiveness of the developed program will be tested in the second part of the study.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Tailored Physical Activity Program for PainExperimental Treatment1 Intervention
Specific characteristics of the intervention delivered in Phase 2 will be based on the information gathered from stakeholders in Phase 1.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials
160
Recruited
48,600+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

A high-intensity functional exercise program was successfully implemented in nursing homes for 93 people with dementia, achieving a median attendance rate of 82.5% and high exercise intensity during sessions.
While the program was generally safe with only minor adverse events reported, factors like low motivation and behavioral symptoms of dementia were identified as barriers to participation and intensity, highlighting the need for strategies to enhance engagement in exercise among this population.
The Applicability of a High-Intensity Functional Exercise Program Among Older People With Dementia Living in Nursing Homes.Sondell, A., Rosendahl, E., Gustafson, Y., et al.[2020]
The Seniors Exercise Park program was found to be safe and feasible for older adults living with dementia, with 88% of participants completing the 12-week program and no adverse events reported.
Participants reported high levels of engagement, enjoyment, and positive mood throughout the program, indicating that individualized communication and adjustments were effective in maintaining motivation and participation.
Exercise interveNtion outdoor proJect in the cOmmunitY - results from the ENJOY program for independence in dementia: a feasibility pilot randomised controlled trial.Levinger, P., Goh, AMY., Dunn, J., et al.[2023]

References

[Pain and physical (in)activity in relation to cognition and behaviour in dementia]. [2022]
Effect of Exercise on Behavioral Symptoms and Pain in Patients With Dementia Living in Nursing Homes. [2020]
Physical inactivity in aging and dementia: a review of its relationship to pain. [2018]
Feasibility and Effectiveness of a Biography-Based Physical Activity Intervention in Institutionalized People With Dementia: Quantitative and Qualitative Results From a Randomized Controlled Trial. [2022]
Increasing Physical Activity in Persons With Dementia: A Randomized Controlled Trial. [2023]
The Applicability of a High-Intensity Functional Exercise Program Among Older People With Dementia Living in Nursing Homes. [2020]
The effects of strEngth aNd BaLance exercise on Executive function in people living with Dementia (ENABLED): Study protocol for a pilot randomized controlled trial. [2023]
Exercise interveNtion outdoor proJect in the cOmmunitY - results from the ENJOY program for independence in dementia: a feasibility pilot randomised controlled trial. [2023]