Survivors Taking Action With Remote Exercise Training (JumpSTART)
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|ClinicalTrials.gov Identifier: NCT04806139|
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : May 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Behavioral: Remote Enhance Fitness||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The intervention will be offered to two groups (goal sample size of 15 participants in each group, with additional recruiting to account for attrition). The second Remote Enhance Fitness group will begin following the completion of the first group.|
|Primary Purpose:||Supportive Care|
|Official Title:||Translation of an Evidence-based Exercise Program for Remote Delivery to Rural, Older Cancer Survivors|
|Actual Study Start Date :||April 7, 2021|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Intervention Group - Remote Enhance Fitness
Participants assigned to the intervention group will participated in a 16-week remote exercise intervention. Following a home/space environment and technology needs assessment, participants will attend a one-on-one orientation and practice class with a research assistant. Participants will join a live-streamed, instructor-led group Enhance Fitness exercise session for 1-hour, 3 days/week for 4 months (16-weeks).
Behavioral: Remote Enhance Fitness
The Remote Enhance Fitness Intervention will include live-streamed exercise classes (1-hour long, 3 days per week, 16 weeks). Certified Enhanced Fitness trainers will lead the exercise classes per Enhance Fitness guidelines, including modifications and gradual progression. During weeks 8-12 participants will have the option to wear a Fitbit during classes for up to 6 class session (2 weeks) for collection of heart rate, steps, and physical activity intensity along with ratings of perceived exertion (RPE) during exercise classes.
No Intervention: Waitlist Control
Participants randomized to the waitlist control group will be offered the opportunity to participate in the Remote Enhance Fitness class after study measures are completed. Cuff weights will be provided along with technical orientation, support, and equipment as needed.
- Patient Reported Outcome Measurement System (PROMIS)-Physical Function10a [ Time Frame: 4 months ]Physical function will be assessed with the PROMIS Physical Function short form. This measure has 10 items and been validated for use in multiple populations including cancer survivors and people with multiple chronic conditions. Scale range is 1-5 (not at all, very much) with higher scores indicating worse physical function.
- Fatigue [ Time Frame: 4 months ]The Patient Reported Outcome Measurement System (PROMIS)-29 will be collected which includes 4 items on fatigue. Scale range is 1-5 (Not at all, Very much). Higher scores indicate worse fatigue
- Sleep disturbance [ Time Frame: 4 months ]The Patient Reported Outcome Measurement System (PROMIS)-29 will be collected which includes 4 items on sleep disturbance. Scale range is 1-5 (Never, Always). Higher scores indicate worse sleep disturbance.
- Physical Activity (PA) and Sedentary Time Assessment [ Time Frame: 4 months ]Physical activity and sedentary time will be assessed using the activPAL accelerometer. Participants will wear the device for seven (7) days during each measurement period. Overall PA levels will be assessed via daily step counts and minutes of moderate-to-vigorous physical activity and will be summed across the week. Accelerometer data will also include sedentary time and light physical activity time.
- Five time sit-to-stand test [ Time Frame: 4 months ]Measure of strength (power): Score is in seconds with higher scores indicating worse physical performance. This assessment will be conducted remotely over video-conference.
- 30 second-sit-to-stand test [ Time Frame: 4 months ]Strength (endurance) will be assessed using the validated 30 second sit-to-stand test: Score is in seconds with higher score indicating better physical performance. This assessment will be conducted remotely over video-conference.
- Four-stage balance test [ Time Frame: 4 months ]Measure of balance: Score is in seconds with completion of all 4 stages indicated better balance. This assessment will be conducted remotely over video-conference.
- Duke Activity Status Index [ Time Frame: 4 months ]Status will be assessed using a 12-item questionnaire that assesses the ability to do self-care, housework, sports, and other activities. Response options are "Yes" or "No" for each of the 12 items. Higher scores indicate higher functional fitness levels.
- Technology Use and Acceptance [ Time Frame: 4 months ]The 14-item short version of the Senior Technology Acceptance Model (STAM) has demonstrated reliability and validity to measure technology-related attitudinal beliefs, control beliefs, and anxiety in older adults. Scale is 1-10 with higher scores indicating higher technology use and acceptance.
- Adapted Technology Acceptance Model Scale [ Time Frame: 4 months ]The 10-item adapted version of the Technology Acceptance Model (TAM) has demonstrated reliability and validity to measure technology-related ease of use, usefulness, financial cost, and intention to use. Scale range is 1-7 (Strongly disagree to Strongly agree) and higher scores indicate better usability, usefulness, and more intention to use.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806139
|Contact: Nancy Gellemail@example.com|
|United States, Vermont|
|University of Vermont||Recruiting|
|Burlington, Vermont, United States, 05405|
|Contact: Nancy Gell, PhD 802-656-9265 firstname.lastname@example.org|
|Principal Investigator:||Nancy Gell||University of Vermont|