Delivery of Enhance Fitness Trial

NCT05275348 | Unknown

• 3 other identifiers: STUDY000140226 U48DP006398-03-016U48DP006398
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

physical activity; arthritis; rural

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Pain Interference

  Study months: 0, 4, 10, 16

• 30-second Sit-to-Stand Test

  Study months: 0, 4

• 30-second Bicep Curl Test

  Study months: 0, 4

• Timed Up and Go Test

  Study months: 0, 4

• Depression

  Study months: 0, 4, 10, 16

Other Outcomes (5)

• International Physical Activity Questionnaire- Short Form

  Study months: 0, 4, 10, 16

• Exercise Self-Efficacy Scale

  Study months: 0, 4, 10, 16

• Anxiety

  Study months: 0, 4, 10, 16

Study Arms (2)

Tele-EF

EXPERIMENTAL

Remote delivery of Enhance Fitness.

Behavioral: Tele-Enhance Fitness

In-person EF

ACTIVE COMPARATOR

In-person delivery of Enhance Fitness.

Behavioral: In-person Enhance Fitness

Interventions

Tele-Enhance Fitness BEHAVIORAL

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.

Tele-EF

In-person Enhance Fitness BEHAVIORAL

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.

In-person EF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• cognitive impairment (Mini Montreal Cognitive Assessment \[Mini MoCA version 2.1\] score \<11)
• significant, non-corrected visual or hearing impairment
• pregnancy

Sponsors & Collaborators

• University of Washington: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Arthritis; Arthritis, Rheumatoid; Fibromyalgia; Gout; Osteoarthritis; Lupus Erythematosus, Systemic; Motor Activity

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Kushang V Patel, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise Hoffman

CONTACT

206-616-4671; evh3@uw.edu

Louisa Sopher

CONTACT

206-221-1765; lsopher@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor: School of Medicine

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 11, 2022
• Study Start: February 2, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

US (1)