Cancer Clinical Trial
Official title:
Technology to Support Exercise Adherence in Project EXCEL Participants
Exercise adherence and maintenance in the EXCEL program supported with a smart phone application: A pilot randomized controlled trial
Status | Recruiting |
Enrollment | 140 |
Est. completion date | June 30, 2023 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria - Have a cancer diagnosis - Be over the age of 18 years - Be able to participate in mild levels of activity as a minimum (to be assessed during screening via the Physical Activity Readiness Questionnaire) - Be pre-treatment, or receiving active cancer treatment, or have received cancer treatment within the past three year - Be able to provide informed written consent in English - Have access to internet service that can support video calling - Be signed up for the EXCEL baseline class Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Physical Activity Minutes Per Week | Change in activity levels from pre to post; Number of participants meeting Guidelines for Physical Activity of 90 minutes per week of moderate to vigorous intensity exercise, based on accelerometer data from commercially-available activity tracker. For the activity tracker each minute in the 55-70 percent age predicted HRmax will be evaluated as moderate intensity and above 70 percent of HRmax will be evaluated as vigorous intensity. Vigorous intensity minutes of physical activity will be doubled and added with moderate intensity minutes to obtain moderate to vigorous physical activity (MVPA) minutes. |
Measured continuously from baseline to 24 weeks | |
Primary | Subjective Physical Activity Minutes Per Week | Change in Physical Activity minutes per week, based on modified Godin Leisure Time Exercise Questionnaire (mGLTEQ). In the mGLTEQ all dimensions (strenuous exercise, moderate exercise, mild exercise, resistance training, and flexibility) will be looked at separately and weekly minutes will be calculated by multiplying duration times frequency of sessions. Vigorous intensity minutes of exercise will be doubled and added with moderate intensity minutes to obtain moderate to vigorous physical activity (MVPA) minutes. Higher scores are better, indicating more minutes of MVPA were accumulated. | Self-reported at baseline, week 4, week 12, and week 24 | |
Primary | EXCEL class attendance | Class attendance (up to 2 x per week) during weeks 1-12 will be recorded by the EXCEL class lead, and input into REDCap. In addition, attendance at subsequent EXCEL maintenance programs (up to week 24) will be recorded | Potential class data in EXCEL baseline and maintenance classes will be recorded, and input into REDCap, from week 1-12 (baseline); and 12-24 (maintenance, optional) | |
Secondary | ZI application usage | Measured directly through the app as logins, tasks completed, pages visited, additional use, and continued usage habits during the maintenance phase | Continuous measurement from baseline to 24 weeks | |
Secondary | Participant Satisfaction | Change in the mobile app usability questionnaire (MAUQ) score. Scores for each item range from 0 (strongly disagree) to 7 (strongly agree), with higher scores indicating greater satisfaction. | Completed at week 4, 12, and 24 | |
Secondary | Body Composition | Change in body mass index (BMI) | Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up) | |
Secondary | Aerobic Endurance | Change in 6-minute walk test (m) or 2 minute step test (steps) results | Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up) | |
Secondary | Upper extremity grip strength | Change in hand-grip dynamometry (kg) | Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up) | |
Secondary | Functional performance test | Change in sit-to-stand (number of repetitions in 30 seconds) | Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up) | |
Secondary | Upper extremity flexibility | Change in active shoulder flexion range of motion (degrees) | Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up) | |
Secondary | Lower extremity flexibility | Change in sit-and-reach test (cm) | Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up) | |
Secondary | Balance | Change in one legged stance test (seconds) | Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up) | |
Secondary | Cancer related symptoms | Change in Edmonton Symptom Assessment Scale. Scores range from 0 to 10 for each item, with a total score ranging from 0 to 100. Higher scores indicate higher symptom burden. | Assessed at baseline and weeks 4, 8, 12, 16, 20, 24 | |
Secondary | General Health-related Quality of Life | Change in EuroQual - 5 Dimensions (EQ-5D) tool. Scores for each item range from 1 to 5, with lower scores indicating better quality of life. | Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up) | |
Secondary | Fatigue | Change in Functional Assessment of Chronic Illness Therapy - Fatigue subscale - scale is from 0-4, where 0 means "not at all" and 4 means "very much". |
Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up) | |
Secondary | General well-being | Change in Functional Assessment of Cancer Therapy - General subscale - scale is from 0-4, where 0 means "not at all" and 4 means "very much". |
Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up) | |
Secondary | Cognition | Change in Functional Assessment of Cancer Therapy - Cognitive subscale - scale is from 0-4, where 0 means "never" and 4 means "several times a day" (experiencing symptoms). |
Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up) | |
Secondary | Barriers and facilitators to exercise participation | Change in Exercise Barriers and Facilitators questionnaire | Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up) | |
Secondary | Exercise adherence | Adherence to exercise programming (attendance at sessions) | Continuous measurement from baseline to 24 weeks | |
Secondary | Participant perceptions of using the ZI application | A purposive sample of participants from the intervention group (n=10-20) will be invited to participate in semi-structured one-on-one interviews. | At 12 and 24 weeks |
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