Clinical trial NCT02734394: UW WELL-FIT Exercise Program for Cancer Patients
Official title: UW WELL-FIT Exercise Program for Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: exercise
body composition
metabolism
nutrition
Lead sponsor: University of Waterloo
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Maximal Exercise Test
timeFrame: 24 sessions (12 weeks)
measure: Upper and Lower Limb Strength
timeFrame: 24 sessions (12 weeks)
measure: Body Mass Index
timeFrame: 24 sessions (12 weeks)
measure: Percent Body Fat
timeFrame: 24 sessions (12 weeks)
Secondary outcomes:
measure: Glucose
timeFrame: 24 sessions (12 weeks)
measure: Lipids
timeFrame: 24 sessions (12 weeks)
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Caryl Russell, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Waterloo
name: Michael Sharratt, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Waterloo
name: Marina Mourtzakis, PhD
role: PRINCIPAL_INVESTIGATOR
References: