Delivery of Enhance Fitness Trial

Rheumatoid Arthritis Clinical Trial

— DEFT  

Official title:

Evaluation of Remotely Delivered Versus In-person Enhance Fitness for Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05275348
• Other study ID #: STUDY00014022
• Secondary ID: 6 U48DP006398-03
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: March 2022
• Source: University of Washington
• Contact: Elise Hoffman
• Phone: 206-616-4671
• Email: evh3[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Fibromyalgia
• Gout
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	International Physical Activity Questionnaire- Short Form	Self-reported time spent engaging in types and intensities of physical activity and sitting time.	Study months: 0, 4, 10, 16
Other	Exercise Self-Efficacy Scale	9 item 0 to 10 scale used to assess participant's confidence in their ability to exercise when presented with obstacles. Total scores range from 0-90 with higher scores indicating higher exercise self-efficacy.	Study months: 0, 4, 10, 16
Other	Anxiety	PROMIS 29 Anxiety short form	Study months: 0, 4, 10, 16
Other	Sleep Disturbance	PROMIS 29 Sleep disturbance short form	Study months: 0, 4, 10, 16
Other	Ability to Participate in Social Roles and Activities	PROMIS 29 Ability to Participate in Social Roles and Activities short form	Study months: 0, 4, 10, 16
Primary	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).	6 month follow up
Secondary	Pain Interference	Measured by the PROMIS 29 Pain Interference Short Form	Study months: 0, 4, 10, 16
Secondary	30-second Sit-to-Stand Test	Standard physical test conducted by Enhance Fitness instructors of number of sit to stands in 30 seconds	Study months: 0, 4
Secondary	30-second Bicep Curl Test	Standard physical test conducted by Enhance Fitness instructors of number of arm curls in 30 seconds	Study months: 0, 4
Secondary	Timed Up and Go Test	Standard physical test conducted by Enhance Fitness instructor of 8 foot timed up-and-go	Study months: 0, 4
Secondary	Depression	PROMIS 29 Depression Short Form	Study months: 0, 4, 10, 16
Secondary	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'.	Study months: 0, 4, 10, 16
Secondary	Fatigue	PROMIS 29 Fatigue Short Form	Study months: 0, 4, 10, 16
Secondary	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).	Study months: 0, 4, 16