Survivors Taking Action With Remote Exercise Training

NCT04806139 | Completed

• 1 other identifier: UVMCC 2100/CHRMS 00001375
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

physical activity; rural; cancer; older adults

Outcome Measures

Primary Outcomes (4)

• Patient Reported Outcome Measurement System (PROMIS)-Physical Function10a

  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.

  4 months

• Fatigue

  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

  4 months

• Sleep disturbance

  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 months

• Physical Activity (PA) and Sedentary Time Assessment

  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.

  4 months

Secondary Outcomes (6)

• Five time sit-to-stand test

  4 months

• 30 second-sit-to-stand test

  4 months

• Four-stage balance test

  4 months

• Duke Activity Status Index

  4 months

• Technology Use and Acceptance

  4 months

Study Arms (2)

Intervention Group - Remote Enhance Fitness

EXPERIMENTAL

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

Waitlist Control

NO INTERVENTION

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.

Interventions

Remote Enhance Fitness BEHAVIORAL

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.

Intervention Group - Remote Enhance Fitness

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Nancy Gell

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 19, 2021
• Study Start: April 7, 2021
• Primary Completion: October 14, 2022
• Study Completion: October 31, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)