Clinical trial NCT05275348: Delivery of Enhance Fitness Trial
Official title: Evaluation of Remotely Delivered Versus In-person Enhance Fitness for Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthritis
Rheumatoid Arthritis
Fibromyalgia
Gout
Osteoarthritis
Lupus or SLE
Keywords: physical activity
arthritis
rural
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2022-03-11
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Patient-Reported Outcome Measurement Information System (PROMIS) 10-item short form
timeFrame: 6 month follow up
Secondary outcomes:
measure: Pain Interference
timeFrame: Study months: 0, 4, 10, 16
measure: 30-second Sit-to-Stand Test
timeFrame: Study months: 0, 4
measure: 30-second Bicep Curl Test
timeFrame: Study months: 0, 4
measure: Timed Up and Go Test
timeFrame: Study months: 0, 4
measure: Depression
timeFrame: Study months: 0, 4, 10, 16
measure: UCLA 3-item Loneliness Scale
timeFrame: Study months: 0, 4, 10, 16
measure: Fatigue
timeFrame: Study months: 0, 4, 10, 16
measure: Patient-Reported Outcome Measurement Information System (PROMIS) 10-item short form
timeFrame: Study months: 0, 4, 16
Other outcomes:
measure: International Physical Activity Questionnaire- Short Form
timeFrame: Study months: 0, 4, 10, 16
measure: Exercise Self-Efficacy Scale
timeFrame: Study months: 0, 4, 10, 16
measure: Anxiety
timeFrame: Study months: 0, 4, 10, 16
measure: Sleep Disturbance
timeFrame: Study months: 0, 4, 10, 16
measure: Ability to Participate in Social Roles and Activities
timeFrame: Study months: 0, 4, 10, 16
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Kushang V Patel, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: