UW WELL-FIT Exercise Program for Cancer Patients

Cancer Clinical Trial

— WELL-FIT  

Official title:

UW WELL-FIT Exercise Program for Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02734394
• Other study ID #: ORE18987-A
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2014
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Exercise
Cardiovascular and resistance exercise training

Locations

Country	Name	City	State
Canada	University of Waterloo	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal Exercise Test	Pre and post maximum workload using an electronic cycle ergometer in Watts	24 sessions (12 weeks)
Primary	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)
Primary	Body Mass Index	Pre and post body mass index (kg/m2)	24 sessions (12 weeks)
Primary	Percent Body Fat	Pre and Post percent body fat (units: %)	24 sessions (12 weeks)
Secondary	Glucose	measurement of blood glucose in mM	24 sessions (12 weeks)
Secondary	Lipids	measurement of total cholesterol, low density lipoprotein,high density lipoprotein ( millimole per liter (mM/L)	24 sessions (12 weeks)