ArthritisDEFTNCT05275348
Delivery of Enhance Fitness Trial
A study testing Tele-Enhance Fitness and In-person Enhance Fitness in people with Arthritis and Rheumatoid Arthritis, run by University of Washington at 1 site in United States.
Trial summary
Arthritis is a common condition in the United States, and a leading cause of pain and disability. Physical exercise is recommended for managing arthritis, but access to evidence-based exercise programs is limited, particularly in rural areas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid Arthritis, Fibromyalgia
- What is being tested?
- Tele-Enhance Fitness and In-person Enhance Fitness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2022to 31 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CDC defined arthritis (answering yes to the following: "Have you EVER been told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia?")
- Community-dwelling
- English-speaking
Who cannot join
- cognitive impairment (Mini Montreal Cognitive Assessment [Mini MoCA version 2.1] score <11)
- significant, non-corrected visual or hearing impairment
- pregnancy
- physician does not recommend exercise due to a contraindicating health condition
- For participants 18-64 years old:
- CDC defined arthritis (answering yes to the following: "Have you EVER been told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia?")
Show all 16Show fewer
- Community-dwelling
- English-speaking
- One of the following additional criteria: (a) moderate-to-severe functional limitation, (b) low household income, or (c) living in a rural area. The definitions of these additional criteria are shown below.
- Functional limitation: Reporting some difficulty or limitation to doing any of the physical activities listed in the PROMIS 10-item Physical Function Short Form (e.g., bathing, dressing, shopping, walking) will be considered to have moderate to severe functional limitation.
- Low Income: Given that income and cost of living can vary geographically (e.g., urban vs. rural), the investigators will use the Department of Housing and Urban Development's low income limit that determines eligibility for various housing programs. Low income is 80 percent of the median income for a given household size and location based on the US Census Bureau's American Community Survey. Lookup tables are published online annually. These questions will be asked in the screening questionnaire by the UW Study Team who will then reference the correct lookup tables to check if participant meets the definition for low income.
- Rural Area: The investigators will apply the widely used National Center for Health Statistics urban-rural classification scheme to identify rural counties. The UW Study Team will ask potential participants the county that they currently live in during the telephone screening and will reference the National Center for Health Statistics urban-rural codes to check if the county is classified as rural.
- cognitive impairment (Mini Montreal Cognitive Assessment [Mini MoCA version 2.1] score <11)
- significant, non-corrected visual or hearing impairment
- pregnancy
- physician does not recommend exercise due to a contraindicating health condition
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Elise Hoffman, 206-616-4671, evh3@uw.edu
About this study
Official title: Evaluation of Remotely Delivered Versus In-person Enhance Fitness for Arthritis
Arthritis is a common condition in the United States, and a leading cause of pain and disability. Physical exercise is recommended for managing arthritis, but access to evidence-based exercise programs is limited, particularly in rural areas. Therefore, the investigators propose to evaluate remote delivery of an evidence-based exercise program called Enhance Fitness (EF) that is recommended for arthritis management. The primary purpose of this study is to determine if remotely delivered EF is non-inferior to in-person EF on primary and secondary outcomes.
- Conditions
- Arthritis, Rheumatoid Arthritis, Fibromyalgia, Gout, Osteoarthritis, Lupus or SLE
- Being tested
- Tele-Enhance Fitness, In-person Enhance Fitness
- Keywords
- physical activity, arthritis, rural
- Medical subject headings
- Arthritis, Arthritis, Rheumatoid, Fibromyalgia, Gout, Osteoarthritis, Lupus Erythematosus, Systemic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-Enhance FitnessBehavioural
Tele-Enhance Fitness (tele-EF) is a community-based exercise program for older adults. It is a supervised group exercise program that will meet virtually 3 times a week for 1 hour for 4 months. Each tele-EF class uses a standardized format that includes a 5-minute warm-up phase, 25 minutes of moderate-intensity aerobic conditioning, 20 minutes of progressive strength training, and 10 minutes of cool down involving flexibility and balance exercises. Strength training involves progressive resistance exercises, using adjustable 1- to 10-pound ankle and wrist weights. Tele-EF classes will be led by an instructor trained in administering EF through a virtual format. EF instructors will be able to monitor and correct participant's movements through videoconference. All tele-EF classes are monitored by a "spotter" who watches participants exercise using gallery mode.
In-person Enhance FitnessBehavioural
Enhance Fitness is a community-based exercise program for older adults. It is a supervised group exercise program that will meet in person 3 times a week for 1 hour for 4 months. Each EF class uses a standardized format that includes a 5-minute warm-up phase, 25 minutes of moderate-intensity aerobic conditioning/walking, 20 minutes of progressive strength training, and 10 minutes of cool down involving flexibility and balance exercises. Strength training involves progressive resistance exercises, using adjustable 1- to 10-pound ankle and wrist weights. Classes will be led by an instructor trained in administering Enhance Fitness.
| Study group | Role | What they receive |
|---|---|---|
| Tele-EF | Experimental | Remote delivery of Enhance Fitness. Receives: Behavioral: Tele-Enhance Fitness |
| In-person EF | Active comparator | In-person delivery of Enhance Fitness. Receives: Behavioral: In-person Enhance Fitness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcome Measurement Information System (PROMIS) 10-item short form
A 10-item questionnaire that assesses the participant's physical functioning (i.e., one's ability to perform activities that require physical action, such as self-care, walking indoors or outdoors, or climbing stairs).
Measured: 6 month follow up
Secondary outcomes (8)
Pain Interference
Measured by the PROMIS 29 Pain Interference Short Form
Measured: Study months: 0, 4, 10, 16
30-second Sit-to-Stand Test
Standard physical test conducted by Enhance Fitness instructors of number of sit to stands in 30 seconds
Measured: Study months: 0, 4
30-second Bicep Curl Test
Standard physical test conducted by Enhance Fitness instructors of number of arm curls in 30 seconds
Measured: Study months: 0, 4
Timed Up and Go Test
Standard physical test conducted by Enhance Fitness instructor of 8 foot timed up-and-go
Measured: Study months: 0, 4
Depression
PROMIS 29 Depression Short Form
Measured: Study months: 0, 4, 10, 16
UCLA 3-item Loneliness Scale
3 question questionnaire used to assess 3 dimensions of loneliness including relational connectedness, social connectedness and self-perceived isolation. Participants rate these domains from 1-3 (hardly ever, some of the time, or often) with a total score from 3-9 with a lower score indicating 'least lonely' and a higher score indicating 'most lonely'.
Measured: Study months: 0, 4, 10, 16
Fatigue
PROMIS 29 Fatigue Short Form
Measured: Study months: 0, 4, 10, 16
Patient-Reported Outcome Measurement Information System (PROMIS) 10-item short form
A 10-item questionnaire that assesses the participant's physical functioning (i.e., one's ability to perform activities that require physical action, such as self-care, walking indoors or outdoors, or climbing stairs).
Measured: Study months: 0, 4, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start2 Feb 2022
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Kushang Patel, University of Washington
- Investigators
- Kushang V Patel, PhD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275348
- Sponsor's protocol ID
- STUDY00014022
- Other IDs
- 6 U48DP006398-03-01, 6U48DP006398
- Acronym
- DEFT
- Status last verified
- Mar 2022
- First submitted
- 9 Feb 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Remotely Delivered Versus In-person Enhance Fitness for Arthritis
- ClinicalTrials.gov ID
- NCT05275348
- Acronym / sponsor ID
- DEFT / STUDY00014022
- Conditions
- Arthritis, Rheumatoid Arthritis, Fibromyalgia, Gout, Osteoarthritis, Lupus or SLE
- Keywords
- physical activity, arthritis, rural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 11 Mar 2022 (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.
Arthritis is a common condition in the United States, and a leading cause of pain and disability. Physical exercise is recommended for managing arthritis, but access to evidence-based exercise programs is limited, particularly in rural areas. Therefore, the investigators propose to evaluate remote delivery of an evidence-based exercise program called Enhance Fitness (EF) that is recommended for arthritis management. The primary purpose of this study is to determine if remotely delivered EF is non-inferior to in-person EF on primary and secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-EF | Experimental | Behavioral: Tele-Enhance FitnessRemote delivery of Enhance Fitness. |
| In-person EF | Active comparator | Behavioral: In-person Enhance FitnessIn-person delivery of Enhance Fitness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CDC defined arthritis (answering yes to the following: "Have you EVER been told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia?")
- Community-dwelling
- English-speaking
Key exclusion criteria (16 listed)
- cognitive impairment (Mini Montreal Cognitive Assessment [Mini MoCA version 2.1] score <11)
- significant, non-corrected visual or hearing impairment
- pregnancy
- physician does not recommend exercise due to a contraindicating health condition
- CDC defined arthritis (answering yes to the following: "Have you EVER been told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia?")
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-Enhance FitnessTele-Enhance Fitness (tele-EF) is a community-based exercise program for older adults. It is a supervised group exercise program that will meet virtually 3 times a week for 1 hour for 4 months. Each tele-EF class uses a standardized format that includes a 5-minute warm-up phase, 25 minutes of moderate-intensity aerobic conditioning, 20 minutes of progressive strength training, and 10 minutes of cool down involving flexibility and balance exercises. Strength training involves progressive resistance exercises, using adjustable 1- to 10-pound ankle and wrist weights. Tele-EF classes will be led by an instructor trained in administering EF through a virtual format. EF instructors will be able to monitor and correct participant's movements through videoconference. All tele-EF classes are monitored by a "spotter" who watches participants exercise using gallery mode. | Behavioural | Tele-EF |
| In-person Enhance FitnessEnhance Fitness is a community-based exercise program for older adults. It is a supervised group exercise program that will meet in person 3 times a week for 1 hour for 4 months. Each EF class uses a standardized format that includes a 5-minute warm-up phase, 25 minutes of moderate-intensity aerobic conditioning/walking, 20 minutes of progressive strength training, and 10 minutes of cool down involving flexibility and balance exercises. Strength training involves progressive resistance exercises, using adjustable 1- to 10-pound ankle and wrist weights. Classes will be led by an instructor trained in administering Enhance Fitness. | Behavioural | In-person EF |
Primary outcome
Patient-Reported Outcome Measurement Information System (PROMIS) 10-item short form
Time frame: 6 month follow up
A 10-item questionnaire that assesses the participant's physical functioning (i.e., one's ability to perform activities that require physical action, such as self-care, walking indoors or outdoors, or climbing stairs).
8 secondary outcomes
Pain Interference
Time frame: Study months: 0, 4, 10, 16
30-second Sit-to-Stand Test
Time frame: Study months: 0, 4
30-second Bicep Curl Test
Time frame: Study months: 0, 4
Timed Up and Go Test
Time frame: Study months: 0, 4
Depression
Time frame: Study months: 0, 4, 10, 16
UCLA 3-item Loneliness Scale
Time frame: Study months: 0, 4, 10, 16
Fatigue
Time frame: Study months: 0, 4, 10, 16
Patient-Reported Outcome Measurement Information System (PROMIS) 10-item short form
Time frame: Study months: 0, 4, 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
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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, MPH 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-Enhance Fitness and In-person Enhance Fitness in people with Arthritis and Rheumatoid Arthritis, 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 3 inclusion and 16 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 11 Mar 2022. 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 Elise Hoffman (206-616-4671, evh3@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcome Measurement Information System (PROMIS) 10-item short form (time frame: 6 month follow up). 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 11 Mar 2022.