CancerWELL-FITNCT02734394
UW WELL-FIT Exercise Program for Cancer Patients
A study testing Exercise in people with Cancer, run by University of Waterloo at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- previously diagnosed with cancer and will currently be receiving some form of treatment (chemotherapy, radiation therapy or hormonal therapy)
Who cannot join
- Physical / health factors that prohibit exercise or lack of medical clearance from physician
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- UW WELL-FIT advertisement for Grand River Regional Cancer Centre
- UW WELL-FIT brochure
- Referral Form
- Participants initial consultation and assessment
- Obtain consent for UW WELL-FIT
- Obtain Participant Information
- Completion of FACIT-F survey
- Metabolism \& Body Composition - Information sheet for optional measures
- Physical Activity Survey- Godin Questionnaire
- Provide 3-Day food diary and Nutritional Assessment
- Fitness assessment, exercise programming and data entry:
- Submaximal cardiovascular cycle ergometer or treadmill graded exercise test
- Muscular strength using force transducer
- Body composition:
- Height, weight and waist girth
- Bioelectrical Impedance Analysis (BIA)
- Dual Energy X-ray Absorption (Optional)
- Range of motion using a goniometer
- Blood sampling (Optional)
- Design Individualized exercise program
- UW WELL-FIT - Commencement of participant in 12 week exercise program (2 x 60 minute classes)
- Post assessment (repeated pre-test assessments)
- Pre and post data are entered into database
- Summary and Feedback Report
- Graduate Program: participant selects to attend UW WELL-FIT Graduate Program
- Participants have annual reassessments in the Graduate Program
- Conditions
- Cancer
- Being tested
- Exercise
- Keywords
- exercise, body composition, metabolism, nutrition
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Cardiovascular and resistance exercise training
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular and strength training exercise | Experimental | 24 sessions (~12 weeks) exercise Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Exercise Test
Pre and post maximum workload using an electronic cycle ergometer in Watts
Measured: 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
Measured: 24 sessions (12 weeks)
Body Mass Index
Pre and post body mass index (kg/m2)
Measured: 24 sessions (12 weeks)
Percent Body Fat
Pre and Post percent body fat (units: %)
Measured: 24 sessions (12 weeks)
Secondary outcomes (2)
Glucose
measurement of blood glucose in mM
Measured: 24 sessions (12 weeks)
Lipids
measurement of total cholesterol, low density lipoprotein,high density lipoprotein ( millimole per liter (mM/L)
Measured: 24 sessions (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startJun 2014
- Primary completionMar 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Fraser, University of Waterloo
- Investigators
- Caryl Russell, MSc, Principal investigator, University of WaterlooMichael Sharratt, PhD, Principal investigator, University of WaterlooMarina Mourtzakis, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734394
- Sponsor's protocol ID
- ORE18987-A
- Acronym
- WELL-FIT
- Status last verified
- Mar 2025
- First submitted
- 9 Feb 2016
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UW WELL-FIT Exercise Program for Cancer Patients
- ClinicalTrials.gov ID
- NCT02734394
- Acronym / sponsor ID
- WELL-FIT / ORE18987-A
- Conditions
- Cancer
- Keywords
- exercise, body composition, metabolism, nutrition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- UW WELL-FIT advertisement for Grand River Regional Cancer Centre
- UW WELL-FIT brochure
- Referral Form
- Participants initial consultation and assessment
- Obtain consent for UW WELL-FIT
- Obtain Participant Information
- Completion of FACIT-F survey
- Metabolism \& Body Composition - Information sheet for optional measures
- Physical Activity Survey- Godin Questionnaire
- Provide 3-Day food diary and Nutritional Assessment
- Fitness assessment, exercise programming and data entry:
- Submaximal cardiovascular cycle ergometer or treadmill graded exercise test
- Muscular strength using force transducer
- Body composition:
- Height, weight and waist girth
- Bioelectrical Impedance Analysis (BIA)
- Dual Energy X-ray Absorption (Optional)
- Range of motion using a goniometer
- Blood sampling (Optional)
- Design Individualized exercise program
- UW WELL-FIT - Commencement of participant in 12 week exercise program (2 x 60 minute classes)
- Post assessment (repeated pre-test assessments)
- Pre and post data are entered into database
- Summary and Feedback Report
- Graduate Program: participant selects to attend UW WELL-FIT Graduate Program
- Participants have annual reassessments in the Graduate Program
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular and strength training exercise | Experimental | Behavioral: Exercise24 sessions (~12 weeks) exercise |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- previously diagnosed with cancer and will currently be receiving some form of treatment (chemotherapy, radiation therapy or hormonal therapy)
Key exclusion criteria (1 listed)
- Physical / health factors that prohibit exercise or lack of medical clearance from physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseCardiovascular and resistance exercise training | Behavioural | Cardiovascular and strength training exercise |
Primary outcome
Maximal Exercise Test
Time frame: 24 sessions (12 weeks)
Pre and post maximum workload using an electronic cycle ergometer in Watts
Upper and Lower Limb Strength
Time frame: 24 sessions (12 weeks)
pre and post strength in upper and lower limb muscles using a linear differential variable transducer (LVDT) measured in Newton.meters
Body Mass Index
Time frame: 24 sessions (12 weeks)
Pre and post body mass index (kg/m2)
Percent Body Fat
Time frame: 24 sessions (12 weeks)
Pre and Post percent body fat (units: %)
2 secondary outcomes
Glucose
Time frame: 24 sessions (12 weeks)
Lipids
Time frame: 24 sessions (12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caryl Russell, MSc principal investigator
University of Waterloo
Michael Sharratt, PhD principal investigator
University of Waterloo
Marina Mourtzakis, PhD principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Cancer, run by University of Waterloo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Exercise Test (time frame: 24 sessions (12 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.