Osteoarthritis, KneeNCT06522906
Mobilizing Hispanics With Knee Osteoarthritis
A study testing Muscle Strengthening, General Physical Activity and Education in people with Osteoarthritis, Knee, run by University of Arizona at 1 site in United States.
Trial summary
The objective is to conduct an early-stage clinical trial in order to provide data required to support a future clinical trial to demonstrate the effectiveness of a culturally acceptable treatment program to increase exercise and regular physical activity among Hispanics with knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Muscle Strengthening, General Physical Activity and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2024to 31 Dec 2025
- Phase
- Interventional
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hispanic/Latino ethnicity
- ≥ 50 years of age
- Access to a device with internet connection
- Chronic, frequent knee pain (National Health and Nutrition Examination Survey criteria)
- Meet American College of Rheumatology criteria for knee OA WOMAC pain score of ≥4 and at least moderate pain (score 2) for at least 2 questions
Who cannot join
- Unknown or non-Hispanic ethnicity
- Condition that prevents ability to provide consent
- Illness with a life expectancy <12 months
- History of arthroplasty or prosthetic leg
- Inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus erythematosus, gout)
- Condition that prevents exercise or physical activity (e.g., unstable cardiovascular disease)
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner University Medical Center
Tucson, Arizona, 85713
About this study
Official title: Mobilizing Hispanics With Knee Osteoarthritis Using a Dyad-based Approach: Pilot Randomized Controlled Trial
The objective is to conduct an early-stage clinical trial in order to provide data required to support a future clinical trial to demonstrate the effectiveness of a culturally acceptable treatment program to increase exercise and regular physical activity among Hispanics with knee osteoarthritis (OA).
Hispanic patients with knee OA paired with a chosen family member/close friend will be recruited for study participation. A pilot randomized controlled trial will be conducted. Study pairs will be randomized to receive either: 1) an intervention that will be administered by live video consultations and will include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving study pairs; or 2) a control treatment that only includes live video educational sessions about OA.
Study participants will fill out a survey before the start of the study and 3 months after.
Read the detailed description
Feasibility of the intervention will be based on the number of study pairs that will be recruited during the study and on attendance to the intervention sessions, and acceptability will be based on quantitative acceptability (e.g., program satisfaction) and qualitative measures.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Muscle Strengthening, General Physical Activity, Education
- Keywords
- Hispanic, Exercise
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle StrengtheningBehavioural
Patients will be offered five video consultations (30-45 minutes each) with a physical therapist over 3 months. The physical therapist will prescribe an exercise program individualized to the OA patient that will include strengthening exercises (2 quadriceps, 1 hip/gluteal, 1 hamstrings/gluteal, 1 calf, and 1 other) to be performed at home 3x/week.
General Physical ActivityBehavioural
The general program will consist of four 60-minute live video consultations conducted by a promotora. The first three sessions will be conducted every 2 weeks, with a booster session occurring one month later. The promotora will help dyads set achievable personalized physical activity goals.
EducationBehavioural
Administered by a promotora, treatment will include 4 live video educational sessions about OA
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Treatments include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving dyads Receives: Behavioral: Muscle Strengthening; Behavioral: General Physical Activity; Behavioral: Education |
| Control | Active comparator | Treatment only includes live video educational sessions about OA Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Educational sessions attended
Number of educational sessions attended by patients and partners will be recorded
Measured: 3 month follow-up
Adherence with muscle strengthening program
Intervention group only. Patients will rate how much they agree/disagree (11-point numerical rating scale) with the statement: "I have been doing my exercises exactly as I was asked by my physical therapist (# sessions, exercises and repetitions)".
Measured: 3 month follow-up
Adherence with physical activity plan
Intervention group only. Study dyads will rate how much they agree/disagree in an 11-point numerical rating scale with the statement: "I followed the physical activity plan that my promotora helped me develop".
Measured: 3 month follow-up
Satisfaction with program
Satisfaction with the program/s, using a 7-point numerical rating scale (1="extremely unsatisfied", 7="extremely satisfied")
Measured: 3 month follow-up
Perceived helpfulness
Perceived helpfulness of the program/s in improving OA symptoms, increasing physical activity and improving communication with their chosen partner, and the likelihood of recommending the program to OA patients and their partners, using a 5-point numerical rating scale (1=not at all/definitely would not, 5=extremely/definitely would not)
Measured: 3 month follow-up
Secondary outcomes (3)
Osteoarthritis disease severity
Severity of OA symptoms will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Change in two subscale scores (joint pain [primary outcome, range 0-20] and physical function [0-68]) will be calculated.
Measured: Baseline and 3 month follow-up
Physical activity
Physical activity will be measured using a pedometer. Participants will be asked to wear a pedometer at the waist for 7 consecutive days to record the number of steps taken per day.
Measured: Baseline and 3 month follow-up
Physical activity (self-report)
Physical activity (self-report) of study dyads in the last week will also be measured using the Physical Activity Scale for the Elderly (range: 0-400, higher scores indicate greater physical activity
Measured: Baseline and 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start15 Nov 2024
- Primary completion30 Nov 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, University of Melbourne
- Responsible party
- Sponsor
- Investigators
- Ernest Vina, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522906
- Sponsor's protocol ID
- 00004081
- Other IDs
- 991639
- Status last verified
- Apr 2026
- First submitted
- 22 Jul 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobilizing Hispanics With Knee Osteoarthritis Using a Dyad-based Approach: Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06522906
- Acronym / sponsor ID
- 00004081
- Conditions
- Osteoarthritis, Knee
- Keywords
- Hispanic, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Temple University, University of Melbourne
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 26 Jul 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 objective is to conduct an early-stage clinical trial in order to provide data required to support a future clinical trial to demonstrate the effectiveness of a culturally acceptable treatment program to increase exercise and regular physical activity among Hispanics with knee osteoarthritis (OA).
Hispanic patients with knee OA paired with a chosen family member/close friend will be recruited for study participation. A pilot randomized controlled trial will be conducted. Study pairs will be randomized to receive either: 1) an intervention that will be administered by live video consultations and will include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving study pairs; or 2) a control treatment that only includes live video educational sessions about OA.
Study participants will fill out a survey before the start of the study and 3 months after.
Detailed description
Feasibility of the intervention will be based on the number of study pairs that will be recruited during the study and on attendance to the intervention sessions, and acceptability will be based on quantitative acceptability (e.g., program satisfaction) and qualitative measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Muscle Strengthening, Behavioral: General Physical Activity, Behavioral: EducationTreatments include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving dyads |
| Control | Active comparator | Behavioral: EducationTreatment only includes live video educational sessions about OA |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hispanic/Latino ethnicity
- ≥ 50 years of age
- Access to a device with internet connection
- Chronic, frequent knee pain (National Health and Nutrition Examination Survey criteria)
- Meet American College of Rheumatology criteria for knee OA WOMAC pain score of ≥4 and at least moderate pain (score 2) for at least 2 questions
Key exclusion criteria (6 listed)
- Unknown or non-Hispanic ethnicity
- Condition that prevents ability to provide consent
- Illness with a life expectancy <12 months
- History of arthroplasty or prosthetic leg
- Inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus erythematosus, gout)
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 |
|---|---|---|
| Muscle StrengtheningPatients will be offered five video consultations (30-45 minutes each) with a physical therapist over 3 months. The physical therapist will prescribe an exercise program individualized to the OA patient that will include strengthening exercises (2 quadriceps, 1 hip/gluteal, 1 hamstrings/gluteal, 1 calf, and 1 other) to be performed at home 3x/week. | Behavioural | Intervention |
| General Physical ActivityThe general program will consist of four 60-minute live video consultations conducted by a promotora. The first three sessions will be conducted every 2 weeks, with a booster session occurring one month later. The promotora will help dyads set achievable personalized physical activity goals. | Behavioural | Intervention |
| EducationAdministered by a promotora, treatment will include 4 live video educational sessions about OA | Behavioural | Control, Intervention |
Primary outcome
Educational sessions attended
Time frame: 3 month follow-up
Number of educational sessions attended by patients and partners will be recorded
Adherence with muscle strengthening program
Time frame: 3 month follow-up
Intervention group only. Patients will rate how much they agree/disagree (11-point numerical rating scale) with the statement: "I have been doing my exercises exactly as I was asked by my physical therapist (# sessions, exercises and repetitions)".
Adherence with physical activity plan
Time frame: 3 month follow-up
Intervention group only. Study dyads will rate how much they agree/disagree in an 11-point numerical rating scale with the statement: "I followed the physical activity plan that my promotora helped me develop".
Satisfaction with program
Time frame: 3 month follow-up
Satisfaction with the program/s, using a 7-point numerical rating scale (1="extremely unsatisfied", 7="extremely satisfied")
Perceived helpfulness
Time frame: 3 month follow-up
Perceived helpfulness of the program/s in improving OA symptoms, increasing physical activity and improving communication with their chosen partner, and the likelihood of recommending the program to OA patients and their partners, using a 5-point numerical rating scale (1=not at all/definitely would not, 5=extremely/definitely would not)
3 secondary outcomes
Osteoarthritis disease severity
Time frame: Baseline and 3 month follow-up
Physical activity
Time frame: Baseline and 3 month follow-up
Physical activity (self-report)
Time frame: Baseline and 3 month follow-up
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 13 Jul 2026.
- 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.
Ernest Vina, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Strengthening, General Physical Activity and Education in people with Osteoarthritis, Knee, run by University of Arizona 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 6 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 13 Jul 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?
Educational sessions attended (time frame: 3 month follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2026.