Survivors Uniting for Remote Guided Exercise

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColorado State University

About this trial

The goal of this research study is to look at how live, online group exercise compares to recorded videos for helping increase physical activity levels, improve physical fitness and quality of life, and reduce loneliness among those living with and beyond cancer. The following aims have been established for this study:

* Aim 1: Examine the effect of a group-based videoconference physical activity (PA) intervention on moderate to vigorous physical activity \[MVPA\] (i.e., aerobic and resistance exercise). * Aim 2: Examine the effect of the intervention on additional health-related outcomes including physical fitness (i.e., aerobic endurance, muscular strength), and quality of life at both timepoints. * Aim 3: Explore potential mediators and moderators of intervention effects. We will examine mediators (e.g., self-efficacy, outcome expectations, group cohesion) and moderators (e.g., age, cancer stage, neighborhood walkability) of the intervention on MVPA. * Exploratory Aim: Determine whether a group-based videoconference PA intervention reduces loneliness among cancer survivors.

Researchers will randomize participants into one of two guided exercise groups that are 12-weeks long in duration. Participants will be asked to complete online fitness assessments and surveys as well as wear a physical activity monitor device and watch a few times throughout the study. The whole study is 9-months long in duration with a 6-month free-living period where no study activities will take place.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to speak/read English,

Diagnosed with any type of cancer within the last 5 years

Completed primary or adjuvant treatment (i.e., chemotherapy, radiation therapy, surgery) with no planned treatment within the next nine months. This does not include long-term or chronic therapies such as anti-hormone or targeted therapies (e.g., aromatase inhibitor, androgen deprivation therapy, immunotherapies)

Disqualifiers

Existing participation in ≥150 minutes per week of at least moderate intensity aerobic exercise

Known contraindications for non-medically supervised moderate or greater intensity exercise (e.g., uncontrolled hypertension, inability to walk without an assistive device)

Current or planned participation in another structured program or intervention intended to encourage participation in exercise or physical activity.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtually Supervised Exercise Sessions

    Behavioral

    The 12-week intervention will consist of supervised exercise sessions twice per week, and PA behavior change discussion sessions twice per month (bi-weekly) throughout the study for a total of five sessions (Week 2, 4, 6, 8 and 10). Exercise and PA behavior change discussion sessions will be informed by social cognitive theory, operationalize several BCT's, and include group dynamics-based strategies to enhance group cohesion. Exercise sessions will take place twice per week, lasting approximately one hour.

  • Asynchronous Group

    Behavioral

    The comparator will be an "unsupported intervention",128 which will use the same technology and provide the same content as the intervention but subtract the human components. Participants in the control group will receive access to pre-recorded (i.e., asynchronous) videos of the exercise and discussion sessions. The exercise videos will follow the same format as those in the intervention (i.e., instructor led, circuit-style aerobic and resistance exercises). Discussion sessions will operationalize the same BCT's using PowerPoint slides. Comparator arm participants will receive instructions on how to access these videos via a unique participant login to a secure website, Canvas, the same recommendations to achieve PA guidelines, and the same home-based exercise equipment (along with instructions for use).

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Intervention (Virtually Supervised Exercise Class)Experimental treatment 1 intervention
Group B: Comparator (Asynchronous Exercise Sessions)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in accelerometer measured moderate to vigorous physical activity from baseline to 3- and 6-month follow-up

MVPA will be compared between the intervention and comparator arm from baseline to post-intervention (primary endpoint) and six-month follow-up.

Time frame
Assessed at baseline, 3-and 6-month follow-up
2

Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 3 and 6 month follow-up

Assessed by Godin Leisure Time Exercise Questionnaire (GLTEQ)

Time frame
Assessed at baseline, 3 and 6-month follow-up

Secondary outcomes

1

Quality of life will be assessed by a quantitative self-report questionnaire

A quality of life survey will be sent at three time points throughout the study: Enrollment, 3-month follow-up, \& 6-month follow-up. QOL is assessed on a scale of (1-5) and has different subscales wherein some subscales have a reverse scoring system.

Time frame
Assessed at baseline and 3 and 6 month follow-up
2

Physical fitness assessed by sit-to-stand and 2-minute step test

Participants will complete a total of three study assessments at the following timepoints: Enrollment, 3 -month follow-up, \& 6-month follow-up from program completion

Time frame
Assessed at baseline and 3 and 6 month follow-up

Other outcomes

Sponsors and contacts

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Colorado State University

Lead sponsor

National Cancer Institute (NCI)

Collaborator