Study for Rural Innovations in the Delivery of Exercise (STRIDE)
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-Enhance Fitness
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Physical Activity, Rural, Older Adults
Eligibility Criteria
Inclusion Criteria:
- Community-dwelling
- English-speaking
- Physician diagnosed knee osteoarthritis
- Knee pain that occurs almost daily for at least the past 3 months and is moderate to severe in intensity
- Knee pain-related difficulty with walking or climbing stairs
- resident of a rural county
Exclusion Criteria:
- cognitive impairment determined by a Mini Montreal Cognitive Assessment score of <11
- any of the following in the past 6 months: cancer requiring treatment (except for non- melanoma skin cancer), heart attack, stroke, hip fracture, hip/knee replacement, spinal surgery, heart surgery, deep vein thrombosis, or pulmonary embolus; and temporary exclusions
- hospitalization within the last month
- ≥3 falls within the past month
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tele-EF
Arm Description
Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training
Outcomes
Primary Outcome Measures
Feasibility and Acceptability of Tele-Enhance Fitness
Feasibility outcomes include intervention engagement and adherence, retention, fidelity of tele-EF treatment, and adverse events. Multiple dimensions of acceptability will be assessed from qualitative interviews with participants and instructors.
Secondary Outcome Measures
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 8-item Short Form
Patient-reported physical functioning
Knee injury and Osteoarthritis Outcome Score (KOOS) Physical Function Subscale
Patient-reported knee pain-related interference with physical functioning
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04881864
Brief Title
Study for Rural Innovations in the Delivery of Exercise
Acronym
STRIDE
Official Title
Adapting an Evidence-Based Exercise Program for Remote Delivery to Rural Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
: Falls are the primary cause of injury and a leading cause of disability and mortality among older adults. Risk factors for falling are common among older adults with knee osteoarthritis (OA) - a highly prevalent condition. Physical exercise is consistently the most efficacious intervention for preventing falls in older adults. However, access to these programs is severely limited in rural settings. Considering that rural communities have a higher disease burden and higher proportion of older adults than non-rural areas, there is a critical need to (1) adapt evidence-based exercise programs for remote delivery to increase access for rural older adults and (2) develop pathways to implement exercise programs in rural health care systems that consistently reach and engage patients with knee OA. Accordingly, the proposed project aims to refine a protocol for remote delivery of Enhance Fitness (EF). EF is an evidence-based, group exercise program involving strength, endurance, and balance training that is recommended for falls prevention and OA management
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Physical Activity, Rural, Older Adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tele-EF
Arm Type
Experimental
Arm Description
Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training
Intervention Type
Behavioral
Intervention Name(s)
Tele-Enhance Fitness
Intervention Description
Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training
Primary Outcome Measure Information:
Title
Feasibility and Acceptability of Tele-Enhance Fitness
Description
Feasibility outcomes include intervention engagement and adherence, retention, fidelity of tele-EF treatment, and adverse events. Multiple dimensions of acceptability will be assessed from qualitative interviews with participants and instructors.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 8-item Short Form
Description
Patient-reported physical functioning
Time Frame
Change from baseline PROMIS physical function score at 12 weeks
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) Physical Function Subscale
Description
Patient-reported knee pain-related interference with physical functioning
Time Frame
Change from Baseline KOOS Physical Function Subscale score at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Community-dwelling
English-speaking
Physician diagnosed knee osteoarthritis
Knee pain that occurs almost daily for at least the past 3 months and is moderate to severe in intensity
Knee pain-related difficulty with walking or climbing stairs
resident of a rural county
Exclusion Criteria:
cognitive impairment determined by a Mini Montreal Cognitive Assessment score of <11
any of the following in the past 6 months: cancer requiring treatment (except for non- melanoma skin cancer), heart attack, stroke, hip fracture, hip/knee replacement, spinal surgery, heart surgery, deep vein thrombosis, or pulmonary embolus; and temporary exclusions
hospitalization within the last month
≥3 falls within the past month
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6540
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators recognize that data sharing leads to the promotion of science. We intend to publish the results of the proposed study and will make data available to investigators upon request (following publication). The final dataset will include demographic, clinical, and behavioral data on 15 older adults followed over a 3-month period. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that the possibility of deductive disclosure of subjects with unusual characteristics remains. For these reasons, we propose to make the data and associated documentation available to users under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Learn more about this trial
Study for Rural Innovations in the Delivery of Exercise
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