Knee OsteoarthritisNCT04706702
Implementation of Tele-Exercise for Management of Knee Osteoarthritis in Older Rural Primary Care Patients
A study testing Tele-EnhanceFitness in people with Knee Osteoarthritis, run by University of Washington at 1 site in United States.
Trial summary
Knee osteoarthritis (OA) is highly prevalent and a leading cause of pain that limits physical functioning in older adults. Clinical practice guidelines recommend physical exercise for managing symptoms of knee OA. As a result, several evidence-based exercise programs have been implemented in community centers. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Tele-EnhanceFitness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 28 Feb 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years
- Community-dwelling
- English-speaking
- Physician diagnosed knee osteoarthritis
- Physically inactive as determined by the 2-item Physical Activity Vital Sign questionnaire
Who cannot join
- Cognitive impairment determined by a Mini Montreal Cognitive Assessment score of <11
- Significant, non-corrected visual or hearing impairment
- Plans to move out of the area in the next 6 months
- Cancer requiring treatment (except for non-melanoma skin cancer) in the past 6 months
- Heart attack in the past 6 months
- Stroke in the past 6 months
Show all 14Show fewer
- Hip fracture in the past 6 months
- Hip/knee replacement in the past 6 months
- Spinal surgery in the past 6 months
- Heart surgery in the past 6 months
- Deep vein thrombosis in the past 6 months
- Pulmonary embolus in the past 6 months
- Hospitalization within the last month
- ≥3 falls within the past month
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington
Seattle, Washington, 98195-6540
About this study
Knee osteoarthritis (OA) is highly prevalent and a leading cause of pain that limits physical functioning in older adults. Clinical practice guidelines recommend physical exercise for managing symptoms of knee OA. As a result, several evidence-based exercise programs have been implemented in community centers. However, access to these programs is severely limited in rural settings. Considering that rural communities have a higher disease burden and higher proportion of older adults than non-rural areas, there is a critical need to (1) adapt evidence-based exercise programs for remote delivery to increase access for rural older adults and (2) develop pathways to implement exercise programs in rural health care systems that consistently reach and engage patients with knee OA. Accordingly, we aim to engage rural primary care practices (including medical directors, clinicians, and staff) to develop a clinical pathway that refers patients to an evidence-based exercise program, called Enhance Fitness® (EF), which we have adapted for remote delivery (tele-EF). Enhance Fitness is a group exercise program that is recommended by the CDC for OA management. It is available in over 800 sites nationally and is covered by Medicare Advantage plans, but it is generally not available in rural communities. In addition, we will assess the feasibility and acceptability of implementing the clinical pathway that identifies physically inactive older patients with knee OA, facilitates exercise prescription, and streamlines referral to tele-EF in a rural primary care clinic over a 5-month period.
- Conditions
- Knee Osteoarthritis
- Being tested
- Tele-EnhanceFitness
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-EnhanceFitnessBehavioural
Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training
| Study group | Role | What they receive |
|---|---|---|
| Tele-EF | Experimental | Tele-EnhanceFitness Receives: Behavioral: Tele-EnhanceFitness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active minutes per day
Average number of minutes spent in moderate to vigorous physical activity as measured by the activPAL accelerometer
Measured: Change from Baseline Active Minutes at 12 weeks
Secondary outcomes (2)
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 8-item Short Form
Patient-reported physical functioning
Measured: Change from Baseline PROMIS Physical Function score at 12 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS) Physical Function Subscale
Patient-reported knee pain-related interference with physical functioning
Measured: Change from Baseline KOOS Physical Function Subscale score at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Mar 2021 (estimated)
- Primary completion18 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kushang Patel, University of Washington
- Investigators
- Kushang V Patel, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706702
- Sponsor's protocol ID
- STUDY00012144
- Status last verified
- Jan 2021
- First submitted
- 8 Jan 2021
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators recognize that data sharing leads to the promotion of science. We intend to publish the results of the proposed study and will make data available to investigators upon request (following publication). The final dataset will include demographic, clinical, and behavioral data on 15 older adults followed over a 3-month period. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that the possibility of deductive disclosure of subjects with unusual characteristics remains. For these reasons, we propose to make the data and associated documentation available to users under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Tele-Exercise for Management of Knee Osteoarthritis in Older Rural Primary Care Patients
- ClinicalTrials.gov ID
- NCT04706702
- Acronym / sponsor ID
- STUDY00012144
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 18 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 13 Jan 2021 (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.
Knee osteoarthritis (OA) is highly prevalent and a leading cause of pain that limits physical functioning in older adults. Clinical practice guidelines recommend physical exercise for managing symptoms of knee OA. As a result, several evidence-based exercise programs have been implemented in community centers. However, access to these programs is severely limited in rural settings. Considering that rural communities have a higher disease burden and higher proportion of older adults than non-rural areas, there is a critical need to (1) adapt evidence-based exercise programs for remote delivery to increase access for rural older adults and (2) develop pathways to implement exercise programs in rural health care systems that consistently reach and engage patients with knee OA. Accordingly, we aim to engage rural primary care practices (including medical directors, clinicians, and staff) to develop a clinical pathway that refers patients to an evidence-based exercise program, called Enhance Fitness® (EF), which we have adapted for remote delivery (tele-EF). Enhance Fitness is a group exercise program that is recommended by the CDC for OA management. It is available in over 800 sites nationally and is covered by Medicare Advantage plans, but it is generally not available in rural communities. In addition, we will assess the feasibility and acceptability of implementing the clinical pathway that identifies physically inactive older patients with knee OA, facilitates exercise prescription, and streamlines referral to tele-EF in a rural primary care clinic over a 5-month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tele-EF | Experimental | Behavioral: Tele-EnhanceFitnessTele-EnhanceFitness |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥65 years
- Community-dwelling
- English-speaking
- Physician diagnosed knee osteoarthritis
- Physically inactive as determined by the 2-item Physical Activity Vital Sign questionnaire
Key exclusion criteria (14 listed)
- Cognitive impairment determined by a Mini Montreal Cognitive Assessment score of <11
- Significant, non-corrected visual or hearing impairment
- Plans to move out of the area in the next 6 months
- Cancer requiring treatment (except for non-melanoma skin cancer) in the past 6 months
- Heart attack in the past 6 months
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 |
|---|---|---|
| Tele-EnhanceFitnessLivestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training | Behavioural | Tele-EF |
Primary outcome
Active minutes per day
Time frame: Change from Baseline Active Minutes at 12 weeks
Average number of minutes spent in moderate to vigorous physical activity as measured by the activPAL accelerometer
2 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 8-item Short Form
Time frame: Change from Baseline PROMIS Physical Function score at 12 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS) Physical Function Subscale
Time frame: Change from Baseline KOOS Physical Function Subscale score at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: Yes. The investigators recognize that data sharing leads to the promotion of science. We intend to publish the results of the proposed study and will make data available to investigators upon request (following publication). The final dataset will include demographic, clinical, and behavioral data on 15 older adults followed over a 3-month period. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that the possibility of deductive disclosure of subjects with unusual characteristics remains. For these reasons, we propose to make the data and associated documentation available to users under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Related trials for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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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.
Kushang V Patel, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-EnhanceFitness in people with Knee Osteoarthritis, run by University of Washington 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 14 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: status not confirmed, as of the sponsor's last update on 13 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kushang V Patel, PhD (2066168052, kvpatel@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active minutes per day (time frame: Change from Baseline Active Minutes at 12 weeks). 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 Jan 2021.