Physical Activity Program for Dementia and Chronic Pain

Overseen By Annalisa Na, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Must not be taking: Pain, Psychotropic

Disqualifiers: Long-term care, Life expectancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to create and test a new exercise program for people with both memory issues and knee pain, often linked to arthritis. In the first part, interviews will gather insights from individuals with these conditions, their care partners, and healthcare professionals to shape the program. The second part will test the developed exercise program, known as the Tailored Physical Activity Program, to evaluate its effectiveness. People aged 60 or older, with mild memory problems and knee pain for at least three months, may be suitable for the study. Participants can choose to join either or both parts of the trial. As an unphased trial, this study offers a unique opportunity to contribute to a program that could improve quality of life for many.

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 prior data suggests that this physical activity program is safe for people with memory problems and knee pain?

Research has shown that personalized exercise programs are generally safe for people with dementia and knee pain. One study found that participants in a similar program experienced fewer health issues compared to those who did not join, with a 48.8% improvement in health outcomes. Another study found that 88% of older adults with dementia safely completed a 12-week exercise program, indicating that these programs are not only feasible but also well-received. Overall, personalized exercise programs appear to be a safe option for improving physical health in older adults with memory challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the tailored physical activity program because it offers a personalized approach to managing dementia and chronic pain, unlike standard treatments that often rely on medications like acetaminophen or NSAIDs. This program is unique as it is customized based on feedback from patients and caregivers, ensuring it addresses specific needs and preferences. By focusing on individualized physical activity, this approach aims to improve both mental and physical well-being, potentially reducing reliance on pharmaceuticals and their associated side effects.

What evidence suggests that this tailored physical activity program could be effective for knee osteoarthritis in people with memory problems?

Research has shown that personalized exercise programs can help people with dementia improve their physical abilities and become more active. In one study with 160 veterans, caregivers observed that participants who followed a customized activity plan experienced much less pain. Another study indicated that personalized physical activity can reduce pain and help people with chronic pain return to their usual activities. This trial will evaluate a Tailored Physical Activity Program for Pain, suggesting that a tailored exercise plan might effectively manage knee pain for people with memory issues. ^{3 4 6 7 8}

Who Is on the Research Team?

Annalisa Na, PT, PhD

Principal Investigator

Drexel University

Are You a Good Fit for This Trial?

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

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)

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Tailored Physical Activity Program

Trial Overview The 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.

How Is the Trial Designed?

Group I: Tailored Physical Activity Program for Pain Experimental Treatment 1 Intervention

Specific characteristics of the intervention delivered in Phase 2 will be based on the information gathered from stakeholders in Phase 1.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26113171/

Efficacy of Tailored Physical Activity or Chronic Pain Self ... Conclusions: The results suggest that TPA is a promising intervention to facilitate return to work and reduce pain among sick-listed citizens with pain related ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07178561

Physical Activity and Exercise for Disability and Improving ... This study evaluated the effects of a combined physical activity and structured exercise program on disability and mental health in elderly ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11807937/

Cost‐Effectiveness of the Tailored Activity Programme for ... These findings indicate TAP is highly cost‐effective for individuals living with dementia compared to usual home care.

4. withpower.com withpower.com/trial/phase-cognitive-dysfunction-9-2023-5ef8f

Physical Activity Program for Dementia and Chronic Pain Studies have found that tailored exercise programs can enhance physical performance and increase activity levels in individuals with dementia, suggesting ...

5. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-021-02511-4

Effects of the tailored activity program (TAP) on dementia ... A trial of 160 Veterans found that TAP caregivers compared to those in usual care, reported significantly less pain in PLWD following ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8527762/

Effects of the tailored activity program (TAP) on dementia ... By 6-months, 15 PLWD in TAP had ≥ 1 health-related event versus 28 PLWD in control, demonstrating 48.8 % improvement in TAP (p = 0.03). TAP ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2682173/

The Tailored Activity Program to Reduce Behavioral ... Caregivers reported high confidence in using activities, being less upset with behavioral symptoms (86%), and enhanced skills (93%) and personal ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167494322000887

Personally tailored exercises for improving physical ... Our findings demonstrated that personally tailored exercises may be a safe and effective approach to improve physical outcomes in older adults living in the ...