Delivery of Enhance Fitness Trial

Not Applicable

• Conditions: Rheumatoid Arthritis; Gout; Lupus or SLE; Fibromyalgia; Osteoarthritis; Arthritis
• Interventions: Behavioral: Tele-Enhance Fitness; Behavioral: In-person Enhance Fitness

• Registration Number: NCT05275348
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-02
• Study First Submitted: 2022-02-09
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-01
• Last Update Submitted: 2022-03-01
• Study First Posted: 2022-03-11
• Last Update Posted: 2022-03-11
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 310

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tele-EF	Tele-Enhance Fitness	Remote delivery of Enhance Fitness.
In-person EF	In-person Enhance Fitness	In-person delivery of Enhance Fitness.

Primary Outcome Measures

Name	Time	Method
Patient-Reported Outcome Measurement Information System (PROMIS) 10-item short form	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).

Secondary Outcome Measures

Name	Time	Method
Pain Interference	Study months: 0, 4, 10, 16	Measured by the PROMIS 29 Pain Interference Short Form
30-second Sit-to-Stand Test	Study months: 0, 4	Standard physical test conducted by Enhance Fitness instructors of number of sit to stands in 30 seconds
30-second Bicep Curl Test	Study months: 0, 4	Standard physical test conducted by Enhance Fitness instructors of number of arm curls in 30 seconds
Timed Up and Go Test	Study months: 0, 4	Standard physical test conducted by Enhance Fitness instructor of 8 foot timed up-and-go
Depression	Study months: 0, 4, 10, 16	PROMIS 29 Depression Short Form
UCLA 3-item Loneliness Scale	Study months: 0, 4, 10, 16	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'.
Fatigue	Study months: 0, 4, 10, 16	PROMIS 29 Fatigue Short Form
Patient-Reported Outcome Measurement Information System (PROMIS) 10-item short form	Study months: 0, 4, 16	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).

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States