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| ID | Type | Description | Link |
|---|---|---|---|
| 6 U48DP006398-03-01 | Other Grant/Funding Number | Centers for Disease Control and Prevention | |
| 6U48DP006398 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele-EF | Experimental | Remote delivery of Enhance Fitness. |
|
| In-person EF | Active Comparator | In-person delivery of Enhance Fitness. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
For participants 65 years or older
Inclusion Criteria:
Exclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elise Hoffman | Contact | 206-616-4671 | evh3@uw.edu | |
| Louisa Sopher | Contact | 206-221-1765 | lsopher@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kushang V Patel, PhD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| D001172 | Arthritis, Rheumatoid |
| D005356 | Fibromyalgia |
| D006073 | Gout |
| D010003 | Osteoarthritis |
| D008180 | Lupus Erythematosus, Systemic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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|
| 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. |
|
| 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 |
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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009135 | Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D000070657 | Crystal Arthropathies |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |