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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
Sponsor:
Information provided by (Responsible Party):
Nancy Gell, University of Vermont

Brief Summary:
The proposed pilot study will test the acceptability and feasibility of a sixteen-week, two-arm randomized control physical activity intervention in older cancer survivors. The Survivors Taking Action with Remote exercise Training (JumpSTART) program is intended for cancer survivors (Stage I-III) age 60 or older, living in rural areas. The goal of this intervention is to increase physical activity opportunities for cancer survivors who are geographically isolated by offering exercise classes (EnhanceFitness) online. The real-time instruction of group-based classes helps older adults to exercise by establishing relationships, fostering social support and receiving corrective and supportive feedback from instructors that enhance self-efficacy for exercise.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Remote Enhance Fitness Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
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.
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rural residence by self-report and confirmed with Rural-Urban Commuting Area Codes
  • Stage I-III cancer history
  • Completion of adjuvant chemotherapy, radiation therapy, or surgery for cancer diagnosis
  • Age 60 years or older
  • Ability to walk for exercise
  • Self-reported minimal or inconsistent participation in strengthening exercise and physical activity (< 150 minutes/week moderate-to-vigorous physical activity; confirmed with baseline accelerometer measures)
  • Clearance for exercise based on a modified, combined Screening Cancer Survivors for Unsupervised Moderate-to-Vigorous Intensity Exercise and the Screening for Physical Activity Readiness Questionnaire (PAR-Q) or physician approval as needed based on the pre-screening/PAR-Q responses

Exclusion Criteria:

  • Not available for the study duration
  • Unable to communicate by phone
  • Unable to attend exercise class at schedule time (M,W,F, time TBD)
  • Currently enrolled in another exercise program
  • Unable to communicate in English

Information from the National Library of Medicine

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


Contacts
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Contact: Nancy Gell 802-656-9265 nancy.gell@med.uvm.edu

Locations
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United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05405
Contact: Nancy Gell, PhD    802-656-9265    nancy.gell@med.uvm.edu   
Sponsors and Collaborators
University of Vermont
Investigators
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Principal Investigator: Nancy Gell University of Vermont
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Responsible Party: Nancy Gell, Associate Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT04806139    
Other Study ID Numbers: UVMCC 2100/CHRMS 00001375
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nancy Gell, University of Vermont:
physical activity
rural
cancer
older adults