Delivery of Enhance Fitness Trial (DEFT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Arthritis; Osteoarthritis; Rheumatoid Arthritis; Fibromyalgia; Gout; Lupus or SLE
• Intervention / Treatment: Behavioral: Tele-Enhance Fitness; Behavioral: In-person Enhance Fitness

• Study Type: Interventional
• Enrollment (Anticipated): 310
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elise Hoffman; Phone Number: 206-616-4671; Email: evh3@uw.edu
• Study Contact Backup: Name: Louisa Sopher; Phone Number: 206-221-1765; Email: lsopher@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington
      • Contact: Elise Hoffman; Phone Number: 206-616-4671; Email: evh3@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tele-EF; Remote delivery of Enhance Fitness.	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.
Active Comparator: In-person EF; In-person delivery of Enhance Fitness.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Interference	Measured by the PROMIS 29 Pain Interference Short Form	Study months: 0, 4, 10, 16
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
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
Timed Up and Go Test	Standard physical test conducted by Enhance Fitness instructor of 8 foot timed up-and-go	Study months: 0, 4
Depression	PROMIS 29 Depression Short Form	Study months: 0, 4, 10, 16
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
Fatigue	PROMIS 29 Fatigue Short Form	Study months: 0, 4, 10, 16
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Anxiety	PROMIS 29 Anxiety short form	Study months: 0, 4, 10, 16
Sleep Disturbance	PROMIS 29 Sleep disturbance short form	Study months: 0, 4, 10, 16
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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Kushang V Patel, PhD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; arthritis; rural
• Additional Relevant MeSH Terms: Nervous System Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Arthritis; Fibromyalgia
• Other Study ID Numbers: STUDY00014022; 6 U48DP006398-03-01 (Other Grant/Funding Number: Centers for Disease Control and Prevention)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No