Recruiting

Enhance Fitness

Sponsor:

University of Washington

Code:

NCT05275348

Conditions

Arthritis

Rheumatoid Arthritis

Fibromyalgia

Gout

Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tele-Enhance Fitness

In-person Enhance Fitness

Study Details

Brief 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. 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

Study ID

NCT05275348

Start date

Feb 2, 2022

Status verified date

Mar, 2022

Completion date

Jan 31, 2024

Anticipated

Primary completion date

Jan 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

For participants 65 years or older

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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?")
  • 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.

1. 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.
2. 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.
3. 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

310 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tele-EF

Remote delivery of Enhance Fitness.

active comparator: In-person EF

In-person delivery of Enhance Fitness.

Interventions

Tele-Enhance Fitness

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 Fitness

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.

Primary outcome measure

  • Patient-Reported Outcome Measurement Information System (PROMIS) 10-item short form [ Time Frame: 6 month follow up ]

Central Contacts and Locations

Central contacts

Elise Hoffman

206-616-4671evh3@uw.edu

Louisa Sopher

206-221-1765lsopher@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Elise Hoffman

206-616-4671evh3@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Mar 11, 2022

Last verified

Mar, 2022

Keywords

  • physical activity
  • arthritis
  • rural

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2022-03-11.