EXCEL: Technology and Exercise Adherence

NCT04790578 | Unknown

• 1 other identifier: HREBA.CC-20-0283
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise adherence and maintenance in the EXCEL program supported with a smart phone application: A pilot randomized controlled trial

Conditions

Cancer

Keywords

Exercise; mHealth

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (17)

• ZI application usage

  Continuous measurement from baseline to 24 weeks

• Participant Satisfaction

  Completed at week 4, 12, and 24

• Body Composition

  Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up)

• Aerobic Endurance

  Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up)

• Upper extremity grip strength

  Assessed at baseline,12-weeks (post-intervention), and 24 weeks (follow-up)

Study Arms (2)

ZoeInsights Application Arm

EXPERIMENTAL

Participants will receive free access to the ZI app for the 12-week intervention. After completing initial set-up, participants will be asked to record physical activity and symptoms regularly via scheduled in-app routines. Further use of ZI (eg. Custom daily routines, additional graphing, medication tracking, accessing linked health resources) during the intervention will be possible ad libitum. After the initial 12-weeks of the EXCEL+ZI intervention, participants have continued free access to the ZI app for up to 1 year.

Device: ZoeInsights Application; Behavioral: EXCEL Exercise Class

Waitlist control

ACTIVE COMPARATOR

During the 12-week intervention the participants will only take part in an online delivered EXCEL exercise class and will not have access to the ZI app. After completion of the 24-week test, the participants will be granted access to the ZI app.

Behavioral: EXCEL Exercise Class

Interventions

ZoeInsights Application DEVICE

ZI is designed to promote PA behavior change and maintenance via self-monitoring of PA, symptoms, and other health data. Additional information for using ZI will be provided via a PDF-based user guide on installing and using the application, a live instructional webinar hosted by ZI developer Hanalytics Solutions, and access to continued support via email/telephone communication with study staff as well as Hanalytics Solutions. Reminders to complete self-monitoring tasks will be provided using daily push notifications scheduled according to participant preferences. Automatic graphs will be generated and displayed within the app to allow participants to visualize trends in physical activity, symptoms, and other health data. ZI can be accessed via a web browser on any device that is connected to the internet (e.g. computer, laptop, tablet, smartphone), or via a native android or iOS mobile application on a smartphone or tablet.

ZoeInsights Application Arm

EXCEL Exercise Class BEHAVIORAL

The group based remote exercise program is delivered twice a week over the Zoom application. Classes are one hour long with a ten minute warm up, 40 minute strength and conditioning focused exercise circuits, and a ten minute stretching. Each class is followed by additional time to provide participants with an opportunity to interact with each other, fostering social support.

Waitlist control; ZoeInsights Application Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

Related Publications (1)

• Ester M, Wagoner CW, Dreger J, Chen G, McDonough MH, McNeely ML, Culos-Reed SN. Effectiveness of a Self-Monitoring App in Supporting Physical Activity Maintenance Among Rural Canadians With Cancer After an Exercise Oncology Program: Cluster Randomized Controlled Trial. JMIR Cancer. 2023 Sep 7;9:e47187. doi: 10.2196/47187.

  PMID: 37676714 DERIVED

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Manuel Ester

CONTACT

+17788144605; manuel.ester@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be unaware of the intervention the participants received. Due to the nature of the intervention (a eHealth application) participants can't be blinded to the intervention. Furthermore, due to the intention to integrate the application as part of extended support provided in the EXCEL program, exercise class instructors (care providers) will be made aware of participant group assignment. The research coordinator will also be aware of the intervention of each participant to aid in troubleshooting with the ZoeInsights application.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants of the EXCEL study will be randomly allocated to either receiving the ZoeInsigths application during their 12 week baseline class + 12 week follow-up (intervention) or only receiving the 12 week baseline class (waitlist control). Those in the waitlist control group will be offered the ZoeInsights application at the end of the 24-week study period after completing their 24-week measures. Block randomization will be used so that all EXCEL participants in a single group-based class will be assigned to either the intervention or waitlist control group.

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 10, 2021
• Study Start: April 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: April 7, 2022

Record last verified: 2022-03

Locations

CA (1)