Osteoarthritis,KneeCoach2MoveNCT07806318
Coach2Move: Physical Therapy to Improve Physical Activity in Individuals With Chronic MSK Conditions
An observational study of Osteoarthritis,Knee and Osteoarthritis Knees Both, run by University of Utah at 1 site in United States.
Trial summary
Chronic musculoskeletal conditions (chronic low back pain, knee osteoarthritis, hip osteoarthritis) are the most common causes of long-term disability resulting in a loss of quality-of life for affected individuals and high costs for society. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis,Knee, Osteoarthritis Knees Both, Osteoarthritis Hip
- What is being tested?
- motivational enhancement and planning
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2022to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients schedule for physical therapy.
Who may be able to join
- Scheduled for physical therapy with a Coach2Move trained physical therapist for chronic hip, knee, or back pain (3 months or more).
- Able to walk around home independently.
- Current hip, knee, or back pain is limiting physical activity
Who cannot join
- Medical provider determines increasing physical activity is not appropriate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leveraging Physical Therapy to Improve Physical Activity in Older Adults With Chronic MSK Conditions.
Chronic musculoskeletal conditions (chronic low back pain, knee osteoarthritis, hip osteoarthritis) are the most common causes of long-term disability resulting in a loss of quality-of life for affected individuals and high costs for society. Regular physical activity can reduce disability and improve quality-of-life but can be challenging in the presence of pain and impaired function. This proposal addresses an urgent need for interventions that support physical activity in this population by leveraging the physical therapy intervention to address symptoms of chronic musculoskeletal conditions and support long-term physical activity engagement.
Read the detailed description
Coach2Move is a patient-centered physical therapy intervention that has demonstrated success in changing physical activity in adults with chronic medical conditions. Coach2Move has only been delivered in the Netherlands with older adults at risk of frailty. It is unclear if it is feasible to deliver this intervention within a U.S. health system and if it would be effective for older adults with chronic MSK conditions. The objective of this research is to adapt and implement the Coach2Move intervention among mid-life and older adults with chronic MSK conditions in a U.S. health care system.
The investigators will do this through the following specific aims:
Aim 1: Adapt the Coach2Move intervention for mid-life and older adults with chronic MSK conditions.
Using a systematic process, intervention mapping, investigators will adapt the Coach2Move training, patient and provider materials to incorporate best evidence for chronic low back pain, and hip/knee osteoarthritis. The investigators will use the logic model from the original Coach2Move program to identify changes necessary for delivery to this population and in the U.S. health system. The adaptation team will include the Coach2Move developers, 2 physical therapists and 2 patient-representatives.
Aim 2: Assess the impact of implementing Coach2Move on patient-level physical activity and function.
With a single group clinical cohort of 104 patients, investigators will examine the impact of the adapted Coach2Move on PA and function 6-months after initiating PT. Investigators will measure implementation with fidelity, dose and reach. Investigators will examine the association between Coach2Move fidelity and dose on PA using regression models and examine reach descriptively across clinics and patient demographics.
Aim 3: Identify Coach2Move implementation barriers and facilitators from both clinician and patient perspectives.
Investigators will evaluate patient and clinician experiences with Coach2Move through semi-structured patient interviews and a clinician focus group. Using interviews with 30 patients receiving the Coach2Move intervention, we will explore the patient experience, perceived burden of the program, and health beliefs. With clinician interviews we will examine barriers and facilitators to implementing Coach2Move.
- Conditions
- Osteoarthritis,Knee, Osteoarthritis Knees Both, Osteoarthritis Hip, Low Back Pain, Chronic Pain, Hip Pain Chronic
- Being tested
- motivational enhancement and planning
- Keywords
- physical therapy, physical activity, motivation, arthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Low Back Pain, Chronic Pain, Motor Activity, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational enhancement and planningBehavioural
Patients will work with physical therapists to identify motivation for physical activity and related goals. Together the patient and the physical therapists will identify ways to address the patient\'s medical condition and how to adapt physical activity if needed given their medical condition(s). Physical therapists will work with a person-centered approach tailoring rehabilitation to the individual patient goals, medical condition, social support, and self-efficacy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported physical activity: International Physical Activity Questionnaire
moderate-vigorous minutes of physical activity per week
Measured: 6 months
Secondary outcomes (5)
Physical activity as measured by accelerometer (Fitbit)
moderate-vigorous minutes of physical activity per week
Measured: 6 months
PROMIS Physical Function
Computer adaptive version 2.0; self-reported physical function
Measured: 6 months
PROMIS Pain Interference
Computer adaptive version 1.1; self-reported activity limitations due to pain
Measured: 6 months
Physical activity self-regulation
Self-reported ability to work through potential barriers to physical activity
Measured: 6 months
PROMIS Self-Efficacy to Manage Symptoms
Computer adaptive version 1.0; self-reported confidence in managing symptoms of chronic conditions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start17 Feb 2022
- Primary completion5 Apr 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis,KneeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Principal investigator, Anne Thackeray, University of Utah
- Investigators
- Anne Thackeray, PhD, MPH, PT, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806318
- Sponsor's protocol ID
- 00174554
- Other IDs
- 1K01HS026518
- Acronym
- Coach2Move
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thackeray A, Waring J, Hoogeboom TJ, Nijhuis-van Der Sanden MWG, Hess R, Fritz JM, Conroy MB, Fernandez ME. Implementing a Dutch Physical Therapy Intervention Into a U.S. Health System: Selecting Strategies Using Implementation Mapping. Front Public Health. 2022 Jul 11;10:908484. doi: 10.3389/fpubh.2022.908484. eCollection 2022.
PubMed 35899163
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Physical Therapy to Improve Physical Activity in Older Adults With Chronic MSK Conditions.
- ClinicalTrials.gov ID
- NCT07806318
- Acronym / sponsor ID
- Coach2Move / 00174554
- Conditions
- Osteoarthritis,Knee, Osteoarthritis Knees Both, Osteoarthritis Hip, Low Back Pain, Chronic Pain, Hip Pain Chronic
- Keywords
- physical therapy, physical activity, motivation, arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 8 Sep 2026 (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.
Chronic musculoskeletal conditions (chronic low back pain, knee osteoarthritis, hip osteoarthritis) are the most common causes of long-term disability resulting in a loss of quality-of life for affected individuals and high costs for society. Regular physical activity can reduce disability and improve quality-of-life but can be challenging in the presence of pain and impaired function. This proposal addresses an urgent need for interventions that support physical activity in this population by leveraging the physical therapy intervention to address symptoms of chronic musculoskeletal conditions and support long-term physical activity engagement.
Detailed description
Coach2Move is a patient-centered physical therapy intervention that has demonstrated success in changing physical activity in adults with chronic medical conditions. Coach2Move has only been delivered in the Netherlands with older adults at risk of frailty. It is unclear if it is feasible to deliver this intervention within a U.S. health system and if it would be effective for older adults with chronic MSK conditions. The objective of this research is to adapt and implement the Coach2Move intervention among mid-life and older adults with chronic MSK conditions in a U.S. health care system.
The investigators will do this through the following specific aims:
Aim 1: Adapt the Coach2Move intervention for mid-life and older adults with chronic MSK conditions.
Using a systematic process, intervention mapping, investigators will adapt the Coach2Move training, patient and provider materials to incorporate best evidence for chronic low back pain, and hip/knee osteoarthritis. The investigators will use the logic model from the original Coach2Move program to identify changes necessary for delivery to this population and in the U.S. health system. The adaptation team will include the Coach2Move developers, 2 physical therapists and 2 patient-representatives.
Aim 2: Assess the impact of implementing Coach2Move on patient-level physical activity and function.
With a single group clinical cohort of 104 patients, investigators will examine the impact of the adapted Coach2Move on PA and function 6-months after initiating PT. Investigators will measure implementation with fidelity, dose and reach. Investigators will examine the association between Coach2Move fidelity and dose on PA using regression models and examine reach descriptively across clinics and patient demographics.
Aim 3: Identify Coach2Move implementation barriers and facilitators from both clinician and patient perspectives.
Investigators will evaluate patient and clinician experiences with Coach2Move through semi-structured patient interviews and a clinician focus group. Using interviews with 30 patients receiving the Coach2Move intervention, we will explore the patient experience, perceived burden of the program, and health beliefs. With clinician interviews we will examine barriers and facilitators to implementing Coach2Move.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients schedule for physical therapy.
Key inclusion criteria (3 listed)
- Scheduled for physical therapy with a Coach2Move trained physical therapist for chronic hip, knee, or back pain (3 months or more).
- Able to walk around home independently.
- Current hip, knee, or back pain is limiting physical activity
Key exclusion criteria (1 listed)
- Medical provider determines increasing physical activity is not appropriate.
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 |
|---|---|---|
| motivational enhancement and planningPatients will work with physical therapists to identify motivation for physical activity and related goals. Together the patient and the physical therapists will identify ways to address the patient\'s medical condition and how to adapt physical activity if needed given their medical condition(s). Physical therapists will work with a person-centered approach tailoring rehabilitation to the individual patient goals, medical condition, social support, and self-efficacy. | Behavioural | – |
Primary outcome
Self-reported physical activity: International Physical Activity Questionnaire
Time frame: 6 months
moderate-vigorous minutes of physical activity per week
5 secondary outcomes
Physical activity as measured by accelerometer (Fitbit)
Time frame: 6 months
PROMIS Physical Function
Time frame: 6 months
PROMIS Pain Interference
Time frame: 6 months
Physical activity self-regulation
Time frame: 6 months
PROMIS Self-Efficacy to Manage Symptoms
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 35899163Thackeray A, Waring J, Hoogeboom TJ, Nijhuis-van Der Sanden MWG, Hess R, Fritz JM, Conroy MB, Fernandez ME. Implementing a Dutch Physical Therapy Intervention Into a U.S. Health System: Selecting Strategies Using Implementation Mapping. Front Public Health. 2022 Jul 11;10:908484. doi: 10.3389/fpubh.2022.908484. eCollection 2022.
- 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. This study is not recruiting at the moment.
Anne Thackeray, PhD, MPH, PT principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis,Knee and Osteoarthritis Knees Both, run by University of Utah 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 8 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported physical activity: International Physical Activity Questionnaire (time frame: 6 months). 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 NCT07806318, which also lists 1 linked publication.
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 8 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.