UW WELL-FIT Exercise Program for Cancer Patients (WELL-FIT)

The purpose of this project is to help to manage the many cancer treatment side effects through cardiovascular and resistance exercise, and education with the goal of using program outcomes to contribute to current research.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Exercise

Detailed Description

This study is a single group pre-test post-test design.There are 4 optional measures that will be presented to participants from which they can choose to participate or not. These are presented with check boxes in the consent form. After completion of the University of Waterloo (UW) WELL-FIT program, participants will be given an option to continue with an exercise program; they will be offered the Graduate Program. Following consent of Graduate Program, repeated measures would be taken annually. At the time of consent, they will have the option to have their data used in research. At any point in their involvement of the exercise based programs, they can indicate "they no longer want to participate in the program or the data collection". Their medical care or participation in the UW WELL-FIT program will not be affected.

Procedures

1. UW WELL-FIT advertisement for Grand River Regional Cancer Centre
2. UW WELL-FIT brochure
3. Referral Form
4. Participants initial consultation and assessment
5. Obtain consent for UW WELL-FIT
6. Obtain Participant Information
7. Completion of FACIT-F survey
8. Metabolism & Body Composition - Information sheet for optional measures
9. Physical Activity Survey- Godin Questionnaire
10. Provide 3-Day food diary and Nutritional Assessment

11. Fitness assessment, exercise programming and data entry:

    1. Submaximal cardiovascular cycle ergometer or treadmill graded exercise test
    2. Muscular strength using force transducer

    3. Body composition:

       • Height, weight and waist girth
       • Bioelectrical Impedance Analysis (BIA)
       • Dual Energy X-ray Absorption (Optional)
    4. Range of motion using a goniometer
    5. Blood sampling (Optional)
    6. Design Individualized exercise program
12. UW WELL-FIT - Commencement of participant in 12 week exercise program (2 x 60 minute classes)
13. Post assessment (repeated pre-test assessments)
14. Pre and post data are entered into database
15. Summary and Feedback Report
16. Graduate Program: participant selects to attend UW WELL-FIT Graduate Program
17. Participants have annual reassessments in the Graduate Program

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• previously diagnosed with cancer and will currently be receiving some form of treatment (chemotherapy, radiation therapy or hormonal therapy)

Exclusion Criteria:

• Physical / health factors that prohibit exercise or lack of medical clearance from physician

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiovascular and strength training exercise; 24 sessions (~12 weeks) exercise	Behavioral: Exercise; Cardiovascular and resistance exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal Exercise Test	Pre and post maximum workload using an electronic cycle ergometer in Watts	24 sessions (12 weeks)
Upper and Lower Limb Strength	pre and post strength in upper and lower limb muscles using a linear differential variable transducer (LVDT) measured in Newton.meters	24 sessions (12 weeks)
Body Mass Index	Pre and post body mass index (kg/m2)	24 sessions (12 weeks)
Percent Body Fat	Pre and Post percent body fat (units: %)	24 sessions (12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose	measurement of blood glucose in mM	24 sessions (12 weeks)
Lipids	measurement of total cholesterol, low density lipoprotein,high density lipoprotein ( millimole per liter (mM/L)	24 sessions (12 weeks)

Collaborators and Investigators

• Sponsor: University of Waterloo
• Investigators: Principal Investigator: Marina Mourtzakis, PhD, University of Waterloo; Principal Investigator: Caryl Russell, MSc, University of Waterloo; Principal Investigator: Michael Sharratt, PhD, University of Waterloo

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (Estimated): April 12, 2016

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: exercise; nutrition; body composition; metabolism
• Other Study ID Numbers: ORE18987-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO