Pain, ChronicNCT06264362
Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia
A study testing Tailored Physical Activity Program in people with Pain, Chronic and Dementia, Mild, run by Drexel University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pain, Chronic, Dementia, Mild, Mobility Limitation
- What is being tested?
- Tailored Physical Activity Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Drexel University
Philadelphia, Pennsylvania, 19104
Annalisa Na, PT, PhD, 267-359-5889, an838@drexel.edu
Ben Senderling, MS, 2673595655, bms422@drexel.edu
About this study
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:
Read more
- Individuals aged 60 years or older who do not live in a nursing home and have both memory issues and knee pain.
- Care partners of people with knee pain and memory issues. A care partner can be a family member or friend who helps regularly.
- 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.
Read the detailed description
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.
- Conditions
- Pain, Chronic, Dementia, Mild, Mobility Limitation, Physical Disability, Osteo Arthritis Knee, Mild Cognitive Impairment
- Being tested
- Tailored Physical Activity Program
- Keywords
- pain, dementia, cognitive impairment, osteoarthritis, knee pain, memory
- Medical subject headings
- Chronic Pain, Dementia, Lymphoma, Follicular, Mobility Limitation, Cognitive Dysfunction, Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Physical Activity ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Tailored Physical Activity Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program parameters
Qualitative interviews to determine preferred program parameters.
Measured: Day 1
Program parameters
Focus groups of clinicians to determine preferred program parameters.
Measured: 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.
Measured: 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
Measured: At study completion, an average of 8 weeks
Secondary outcomes (2)
Numeric Pain Score
A self-reported pain measurement ranging from 0 (no pain) to 10 (worst pain). A high score indicates more pain.
Measured: Through study completion, an average of 8 weeks.
Zarit Burden Interview-Short Form
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.
Measured: At study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start2 Jun 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (89)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Annalisa Na, PT, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264362
- Sponsor's protocol ID
- K23AG081547
- Other IDs
- 1K23AG081547-01
- Status last verified
- Mar 2025
- First submitted
- 14 Dec 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32333589Hunt 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.
PubMed 26200445Sverdrup 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.
PubMed 32060802Tanaka 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.
PubMed 31883310APTA 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.
PubMed 34928240Gitlin 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.
PubMed 29192967Whitlock 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.
PubMed 28586818Hodgson N, Gitlin LN, Huang J. The influence of sleep disruption and pain perception on indicators of quality of life in individuals living with dementia at home. Geriatr Nurs. 2014 Sep-Oct;35(5):394-8. doi: 10.1016/j.gerinurse.2014.08.005. Epub 2014 Sep 2.
PubMed 25193739Monroe TB, Misra SK, Habermann RC, Dietrich MS, Cowan RL, Simmons SF. Pain reports and pain medication treatment in nursing home residents with and without dementia. Geriatr Gerontol Int. 2014 Jul;14(3):541-8. doi: 10.1111/ggi.12130. Epub 2013 Sep 11.
PubMed 24020433Rundell SD, Phelan EA, Patel KV, Jones BL, Marcum ZA. Longitudinal Patterns of Pain Reporting Among Community-dwelling Older Adults. Clin J Pain. 2020 Dec;36(12):912-922. doi: 10.1097/AJP.0000000000000874.
PubMed 328419702020 Alzheimer's disease facts and figures. Alzheimers Dement. 2020 Mar 10. doi: 10.1002/alz.12068. Online ahead of print.
PubMed 32157811AGS clinical practice guidelines: the management of chronic pain in older persons. Geriatrics. 1998 Oct;53 Suppl 3:S6-7. No abstract available.
PubMed 9826951Bullock L, Bedson J, Jordan JL, Bartlam B, Chew-Graham CA, Campbell P. Pain assessment and pain treatment for community-dwelling people with dementia: A systematic review and narrative synthesis. Int J Geriatr Psychiatry. 2019 Jun;34(6):807-821. doi: 10.1002/gps.5078. Epub 2019 Apr 8.
PubMed 30724409Bullock L, Chew-Graham CA, Bedson J, Bartlam B, Campbell P. The challenge of pain identification, assessment, and management in people with dementia: a qualitative study. BJGP Open. 2020 Jun 23;4(2):bjgpopen20X101040. doi: 10.3399/bjgpopen20X101040. Print 2020.
PubMed 32457099Corbett A, Nunez KM, Smeaton E, Testad I, Thomas AJ, Closs SJ, Briggs M, Clifton L, Gjestsen MT, Lawrence V. The landscape of pain management in people with dementia living in care homes: a mixed methods study. Int J Geriatr Psychiatry. 2016 Dec;31(12):1354-1370. doi: 10.1002/gps.4445. Epub 2016 Feb 21.
PubMed 26898542
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia
- ClinicalTrials.gov ID
- NCT06264362
- Acronym / sponsor ID
- K23AG081547
- Conditions
- Pain, Chronic, Dementia, Mild, Mobility Limitation, Physical Disability, Osteo Arthritis Knee, Mild Cognitive Impairment
- Keywords
- pain, dementia, cognitive impairment, osteoarthritis, knee pain, memory
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Jun 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Individuals aged 60 years or older who do not live in a nursing home and have both memory issues and knee pain.
- Care partners of people with knee pain and memory issues. A care partner can be a family member or friend who helps regularly.
- 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tailored Physical Activity Program for Pain | Experimental | Behavioral: Tailored Physical Activity ProgramSpecific characteristics of the intervention delivered in Phase 2 will be based on the information gathered from stakeholders in Phase 1. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored Physical Activity ProgramAdaptation 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. | Behavioural | Tailored Physical Activity Program for Pain |
Primary outcome
Program parameters
Time frame: Day 1
Qualitative interviews to determine preferred program parameters.
Program parameters
Time frame: Day 1
Focus groups of clinicians to determine preferred program parameters.
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.
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
2 secondary outcomes
Numeric Pain Score
Time frame: Through study completion, an average of 8 weeks.
Zarit Burden Interview-Short Form
Time frame: At study completion, an average of 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Background: PubMed 32333589Innes 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.
- Background: PubMed 26200445Hunt 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.
- Background: PubMed 32060802Sverdrup 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.
- Background: PubMed 31883310Tanaka 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.
- Background: PubMed 34928240APTA 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.
- Background: PubMed 29192967Gitlin 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.
- Background: PubMed 28586818Whitlock 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.
- Background: PubMed 25193739Hodgson N, Gitlin LN, Huang J. The influence of sleep disruption and pain perception on indicators of quality of life in individuals living with dementia at home. Geriatr Nurs. 2014 Sep-Oct;35(5):394-8. doi: 10.1016/j.gerinurse.2014.08.005. Epub 2014 Sep 2.
- Background: PubMed 24020433Monroe TB, Misra SK, Habermann RC, Dietrich MS, Cowan RL, Simmons SF. Pain reports and pain medication treatment in nursing home residents with and without dementia. Geriatr Gerontol Int. 2014 Jul;14(3):541-8. doi: 10.1111/ggi.12130. Epub 2013 Sep 11.
- Background: PubMed 32841970Rundell SD, Phelan EA, Patel KV, Jones BL, Marcum ZA. Longitudinal Patterns of Pain Reporting Among Community-dwelling Older Adults. Clin J Pain. 2020 Dec;36(12):912-922. doi: 10.1097/AJP.0000000000000874.
- Background: PubMed 321578112020 Alzheimer's disease facts and figures. Alzheimers Dement. 2020 Mar 10. doi: 10.1002/alz.12068. Online ahead of print.
- Background: PubMed 9826951AGS clinical practice guidelines: the management of chronic pain in older persons. Geriatrics. 1998 Oct;53 Suppl 3:S6-7. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annalisa Na, PT, PhD principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Physical Activity Program in people with Pain, Chronic and Dementia, Mild, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annalisa Na, PT, PhD (2673595889, an838@drexel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program parameters (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06264362, which also lists 89 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.