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Delivery of Enhance Fitness Trial (DEFT)

Primary Purpose

Arthritis, Rheumatoid Arthritis, Fibromyalgia

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Tele-Enhance Fitness

In-person Enhance Fitness

About this trial

This is an interventional treatment trial for Arthritis focused on measuring physical activity, arthritis, rural

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tele-EF

In-person EF

Arm Description

Remote delivery of Enhance Fitness.

In-person delivery of Enhance Fitness.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Pain Interference

Measured by the PROMIS 29 Pain Interference Short Form

30-second Sit-to-Stand Test

Standard physical test conducted by Enhance Fitness instructors of number of sit to stands in 30 seconds

30-second Bicep Curl Test

Standard physical test conducted by Enhance Fitness instructors of number of arm curls in 30 seconds

Timed Up and Go Test

Standard physical test conducted by Enhance Fitness instructor of 8 foot timed up-and-go

Depression

PROMIS 29 Depression Short Form

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'.

Fatigue

PROMIS 29 Fatigue Short Form

Patient-Reported Outcome Measurement Information System (PROMIS) 10-item short form

Full Information

NCT ID

NCT05275348

First Posted

February 9, 2022

Last Updated

March 1, 2022

Sponsor

University of Washington

Collaborators

Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT05275348

Brief Title

Delivery of Enhance Fitness Trial

Acronym

DEFT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 2, 2022 (Actual)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

Collaborators

Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

physical activity, arthritis, rural

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tele-EF

Arm Type

Experimental

Arm Description

Remote delivery of Enhance Fitness.

Arm Title

In-person EF

Arm Type

Active Comparator

Arm Description

In-person delivery of Enhance Fitness.

Intervention Type

Behavioral

Intervention Name(s)

Tele-Enhance Fitness

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

In-person Enhance Fitness

Intervention Description

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.

Primary Outcome Measure Information:

Title

Patient-Reported Outcome Measurement Information System (PROMIS) 10-item short form

Description

Time Frame

6 month follow up

Secondary Outcome Measure Information:

Title

Pain Interference

Description

Measured by the PROMIS 29 Pain Interference Short Form

Time Frame

Study months: 0, 4, 10, 16

Title

30-second Sit-to-Stand Test

Description

Standard physical test conducted by Enhance Fitness instructors of number of sit to stands in 30 seconds

Time Frame

Study months: 0, 4

Title

30-second Bicep Curl Test

Description

Standard physical test conducted by Enhance Fitness instructors of number of arm curls in 30 seconds

Time Frame

Study months: 0, 4

Title

Timed Up and Go Test

Description

Standard physical test conducted by Enhance Fitness instructor of 8 foot timed up-and-go

Time Frame

Study months: 0, 4

Title

Depression

Description

PROMIS 29 Depression Short Form

Time Frame

Study months: 0, 4, 10, 16

Title

UCLA 3-item Loneliness Scale

Description

Time Frame

Study months: 0, 4, 10, 16

Title

Fatigue

Description

PROMIS 29 Fatigue Short Form

Time Frame

Study months: 0, 4, 10, 16

Title

Patient-Reported Outcome Measurement Information System (PROMIS) 10-item short form

Description

Time Frame

Study months: 0, 4, 16

Other Pre-specified Outcome Measures:

Title

International Physical Activity Questionnaire- Short Form

Description

Self-reported time spent engaging in types and intensities of physical activity and sitting time.

Time Frame

Study months: 0, 4, 10, 16

Title

Exercise Self-Efficacy Scale

Description

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.

Time Frame

Study months: 0, 4, 10, 16

Title

Anxiety

Description

PROMIS 29 Anxiety short form

Time Frame

Study months: 0, 4, 10, 16

Title

Sleep Disturbance

Description

PROMIS 29 Sleep disturbance short form

Time Frame

Study months: 0, 4, 10, 16

Title

Ability to Participate in Social Roles and Activities

Description

PROMIS 29 Ability to Participate in Social Roles and Activities short form

Time Frame

Study months: 0, 4, 10, 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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. 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. 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elise Hoffman

Phone

206-616-4671

evh3@uw.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Louisa Sopher

Phone

206-221-1765

lsopher@uw.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kushang V Patel, PhD, MPH

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elise Hoffman

Phone

206-616-4671

evh3@uw.edu

12. IPD Sharing Statement

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Delivery of Enhance Fitness Trial

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