Delivery of Enhance Fitness Trial (DEFT)

University of Washington

Status: Unknown

Conditions: Lupus or SLE; Fibromyalgia; Osteoarthritis; Arthritis; Gout; Rheumatoid Arthritis

Treatments: Behavioral: Tele-Enhance Fitness; Behavioral: In-person Enhance Fitness

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05275348

6 U48DP006398-03-01 (Other Grant/Funding Number)

STUDY00014022

Details and patient eligibility

About

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.

Enrollment: 310 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

Tele-EF

Experimental group

Description:

Remote delivery of Enhance Fitness.

Treatment:

Behavioral: Tele-Enhance Fitness

In-person EF

Active Comparator group

Description:

In-person delivery of Enhance Fitness.

Treatment:

Behavioral: In-person Enhance Fitness