CancerPhase 2ACE-Dose-CRCNCT07913906
Alberta Cancer Exercise Dose in Colorectal Cancer
A Phase 2 study testing Group Exercise Classes - Arm 1 and Group Exercise Classes - Arm 2 in people with Cancer and Colorectal Cancer, run by University of Calgary at 1 site in Canada.
Trial summary
The purpose of this pilot randomized, wait-list controlled study is to evaluate the effects of exercise dose in terms of frequency (1 vs. 2 days per week) in individuals on systemic treatment for colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Colorectal Cancer
- What is being tested?
- Group Exercise Classes - Arm 1 and Group Exercise Classes - Arm 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2027to Jan 2029
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18)
- Have a primary biopsy-proven diagnosis of colon or rectal adenocarcinoma and undergoing adjuvant systemic treatment
- Cleared for exercise (PAR-Q+)
- Able to attend scheduled sessions
- Able to provide informed written consent in English.
- Not meeting current aerobic exercise guidelines (i.e. performing < 90 minutes of moderate to vigorous physical activity per week in the past month)
Who cannot join
- Participants who have completed adjuvant treatment for CRC
- Unstable cardiopulmonary disease
- Uncontrolled hypertension
- Active infection
- Recent autoimmune flare
- Contraindication to needles/venipuncture
- Grade 2 or higher diarrhea secondary to systemic treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Arthur J.E. Child Comprehensive Cancer Centre - Gastrointestinal tumour group outpatient clinics
Calgary, Alberta, T2N 5G2
Safiya Karim, MD, 403-521-3166, karis@ucalgary.ca
Aude-Marie Foucaut Beaucage, PhD, 403-210-8482, audemarie.foucaut@ucalgary.ca
About this study
The purpose of this pilot randomized, wait-list controlled study is to evaluate the effects of exercise dose in terms of frequency (1 vs. 2 days per week) in individuals on systemic treatment for colorectal cancer. The impact on the individual (physical function, quality of life, fatigue and other patient reported outcomes) as well as on health care utilization (cost to deliver, cost to individuals, savings and impact to the health care system) will be evaluated. In addition, assessments of immunological markers to better understand the biological impact of exercise dose on immunological markers will be explored.
Read the detailed description
Background and Rationale: There is a growing interest in optimizing exercise strategies that can enhance the well-being of individuals living with and beyond cancer (ILWBC). ILWBC frequently experience declines in physical function and QoL during and after treatment, and exercise is one of the few interventions consistently shown to address these challenges. This is of particular importance for individuals living with colorectal cancers, who face fluctuating treatment effects and often struggle to adhere to higher volumes of exercise. Many exercise oncology programs are standardized to reach guidelines levels of 90 or 150 minutes per week (ie, approximately 2-3 sessions/week), and this dose of exercise can impact both attendance (adherence to the sessions) as well as the effectiveness (outcomes, physical, fitness, and psychosocial). Questions thus remain about the most effective, practical, and sustainable "dose" - the frequency of supervised exercise - required to achieve meaningful benefits. In addition, there are questions of sustainability of delivering exercise within cancer care. The dose is thus a critical issue to examine, not only for feasibility of attendance by ILWBC and their anticipated benefits, but also in terms of the economics. There is a paucity of literature examining the economics of exercise dose (cost to deliver based on times per week), as well as a general lack of understanding the health economics (cost to deliver, cost to individuals, savings and impact on the cancer care system).
In Calgary, the principal investigator have developed the existing ACE program (now called the Thrive Cancer Exercise Program) which offers participants a 12-week exercise oncology program with 2 classes per week. The original ACE study, baseline characteristics, and initial examination of program impact highlight the value of the ACE exercise intervention for ILWBC. This published work has resulted in streamlining ACE to program implementation and evaluation (HREBA.CC-24-0252). With increased clinical referral, the waitlist to the ongoing Thrive Cancer Exercise Program is growing. There is thus a pragmatic need to establish the optimal dose of exercise, to determine if a sustainable model of one class per week is sufficient to garner potential benefits and meet the growing clinical demand, as well as optimize health care costs and savings.
Research Question and Objectives: The purpose of this study is to evaluate the effects of exercise dose in terms of frequencies (one vs. two days per week) in individuals on treatment for colorectal cancer. The impact not only on the individual (potential benefits of exercise), but also in terms of cost will be assessed. In addition, assessments of immunological markers, physical function, QoL, fatigue, symptoms and exercise experience will occur.
Methods: This RCT study is a three-arm, parallel-group trial delivered through the Thrive Cancer Exercise Program at the Arthur J.E. Child Comprehensive Cancer Centre (ACCCC) Stride Centre and Rehab gym. Participants will be randomized (1:1:1) to: 1) Once/week (n = 30); 2) Twice/week for 12 weeks (n = 30); 3) Control-waitlisted to start Thrive Cancer Exercise Program after study completion (n = 30).
ACE-Dose classes will be delivered by Clinical Exercise Physiologists (CEPs) trained to lead high-risk participant classes. The program is a combination of aerobic, resistance, balance, and flexibility exercises delivered in group circuit-style class. The Thrive Cancer Exercise Program current infrastructure and referral process will be used.
Baseline, 12 weeks, 24 weeks and 52 weeks assessments will be done. The following information will be collected: 1) Attendance and Adverse event; 2) Health economics (work and productivity, time and income loss, informal care and daily impact, treatment attendance and travel, out-of-pocket costs, and medications and cost for cancer); 3) Bloodwork conducted by a phlebotomist to assess Immunological markers; 4) Patient-reported outcomes through standardized questionnaires (Quality of life, Fatigue, Symptom management, Exercise Barriers and Facilitators); 5) Physical activity \& function assessments (Subjective Physical activity level, Cardiorespiratory fitness, Musculoskeletal fitness, Flexibility, Balance, and Anthropometrics); 6) Garmin data (step counts per day and heart rate) to assess objective Physical Activity Level; 7) Qualitative interview on Program experience.
- Conditions
- Cancer, Colorectal Cancer
- Being tested
- Group Exercise Classes - Arm 1, Group Exercise Classes - Arm 2
- Keywords
- dose-response, physical activity level, fitness, health economics, immunology, quality of life, cancer, colorectal cancer, adjuvant treatment
- Medical subject headings
- Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Exercise Classes - Arm 1Behavioural
Interventional arm 1 complete the supervised 60-min exercise classes for 12 weeks at low-to-moderate intensity, progressing individually (warm-up, aerobic intervals, multi-joint resistance, balance/flexibility cool-down), once-weekly.
Sessions are delivered in-person by a CEP at the ACCCC Stride Centre. Attendance, RPE, and any modifications/adverse events are logged each session.
In addition to exercise, 5 behaviour components will be covered throughout the program using an "Exercise and Educate" model, to support behaviour change. The trained instructor will build a positive motivational climate utilizing training in health coaching and motivational interviewing.
Group Exercise Classes - Arm 2Behavioural
Interventional arm 2 complete the supervised 60-min exercise classes for 12 weeks at low-to-moderate intensity, progressing individually (warm-up, aerobic intervals, multi-joint resistance, balance/flexibility cool-down), twice-weekly.
Sessions are delivered in-person by a CEP at the ACCCC Stride Centre. Attendance, RPE, and any modifications/adverse events are logged each session.
In addition to exercise, 5 behaviour components will be covered throughout the program using an "Exercise and Educate" model, to support behaviour change. The trained instructor will build a positive motivational climate utilizing training in health coaching and motivational interviewing.
| Study group | Role | What they receive |
|---|---|---|
| Once/week exercise session for 12 weeks (Arm 1) | Experimental | Arm 1 will be supervised by a CEP once a week (e.g. Tuesday or Thursday) at the ACCCC. The exercise program includes aerobic, strength and balance / flexibility exercises for 12 week. Receives: Behavioral: Group Exercise Classes - Arm 1 |
| Twice/week exercise session for 12 weeks (Arm 2) | Active comparator | Arm 2 will be supervised by a CEP twice a week (e.g. Tuesday and Thursday) at the ACCCC. The exercise program includes aerobic, strength and balance / flexibility exercises for 12 week. Receives: Behavioral: Group Exercise Classes - Arm 2 |
| Control-waitlisted group (Arm 3) | No intervention | Standard of care control-waitlisted group to start the Thrive program after 24 weeks on a voluntary basis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in the once per week and twice per week group that achieve an increase of ≥10 MET-h/wk of total physical activity level at 12 weeks.
To assess the dose-response effect of exercise frequency (once versus twice weekly) over a 12-week period on clinically meaningful improvements in physical activity level (≥10 MET-h/wk increase over baseline) in patients with early-stage CRC receiving systemic treatment, with the goal of identifying the minimal effective intervention frequency
Measured: Single time point: 12 weeks
Secondary outcomes (6)
Number of participants with exercise-related adverse events with CTCAE standardized reports
To assess safety of the once per week versus twice per week supervised exercise
Measured: From enrollment to 24 weeks
Difference in health economic and health care utilization between groups over 52 weeks
Indirect costs of cancer, work and productivity, time and income loss, informal care and daily impact, treatment attendance and travel, out-of-pocket costs, medications and cost for cancer treatment, emergency department admissions, and hospitalizations
Measured: From enrollment to 52 weeks
Changes from baseline in the PROs at 12 weeks, and at 24- and 52-week follow-ups.
Assess changes in patient-reported outcomes (PROs) - including quality of life, functional abilities, cognitive function, well-being, fatigue, and symptoms - from the start of the study through the end of the intervention, and then at follow-up visits.
Measured: From enrollment to the end of the study at 52 weeks
Changes from baseline in anthropometric parameters and fitness level at 12 weeks, and at the 24- and 52-week follow-ups.
Assess changes in anthropometric parameters (height and weight) and physical fitness - including cardiorespiratory fitness, musculoskeletal fitness, flexibility and balance - from the start of the study through the end of the intervention, and then at follow-up visits.
Measured: From enrollment to the end of the study at 52 weeks
Changes from baseline in objective physical activity level at 12 weeks, and at the 24-week follow-up.
Assess step count and heart rate, as per the Garmin fitness tracker watch data. Participants will be asked to wear the tracker for at least 10 hours per day for 24 weeks, unless the device is charging.
Measured: From enrollment to 24 weeks
Participant experience and perceived tolerability of the ACE-dose program at 12 weeks
Assess participant experience of the ACE-dose program, including overall experience and manageability and tolerability of treatment-related side effects during the program with semi-structured interviews at 12 weeks.
Measured: Single time point: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (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.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a three-arm RCT employing a non-inferiority design for the primary comparison between active arms (arms 1 and 2), with superiority comparisons against the waitlist control (arm 3) (i.e. non-inferiority superiority hybrid design).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Arthur J.E. Child Comprehensive Cancer Centre
- Responsible party
- Sponsor
- Investigators
- S. Nicole Culos-Reed, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913906
- Sponsor's protocol ID
- HREBA.CC-26-0061
- Acronym
- ACE-Dose-CRC
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan at this time to share IPD outside of research team
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alberta Cancer Exercise Dose in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07913906
- Acronym / sponsor ID
- ACE-Dose-CRC / HREBA.CC-26-0061
- Conditions
- Cancer, Colorectal Cancer
- Keywords
- dose-response, physical activity level, fitness, health economics, immunology, quality of life, cancer, colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Arthur J.E. Child Comprehensive Cancer Centre
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 3 Nov 2026 (actual)
- 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 pilot randomized, wait-list controlled study is to evaluate the effects of exercise dose in terms of frequency (1 vs. 2 days per week) in individuals on systemic treatment for colorectal cancer. The impact on the individual (physical function, quality of life, fatigue and other patient reported outcomes) as well as on health care utilization (cost to deliver, cost to individuals, savings and impact to the health care system) will be evaluated. In addition, assessments of immunological markers to better understand the biological impact of exercise dose on immunological markers will be explored.
Detailed description
Background and Rationale: There is a growing interest in optimizing exercise strategies that can enhance the well-being of individuals living with and beyond cancer (ILWBC). ILWBC frequently experience declines in physical function and QoL during and after treatment, and exercise is one of the few interventions consistently shown to address these challenges. This is of particular importance for individuals living with colorectal cancers, who face fluctuating treatment effects and often struggle to adhere to higher volumes of exercise. Many exercise oncology programs are standardized to reach guidelines levels of 90 or 150 minutes per week (ie, approximately 2-3 sessions/week), and this dose of exercise can impact both attendance (adherence to the sessions) as well as the effectiveness (outcomes, physical, fitness, and psychosocial). Questions thus remain about the most effective, practical, and sustainable "dose" - the frequency of supervised exercise - required to achieve meaningful benefits. In addition, there are questions of sustainability of delivering exercise within cancer care. The dose is thus a critical issue to examine, not only for feasibility of attendance by ILWBC and their anticipated benefits, but also in terms of the economics. There is a paucity of literature examining the economics of exercise dose (cost to deliver based on times per week), as well as a general lack of understanding the health economics (cost to deliver, cost to individuals, savings and impact on the cancer care system).
In Calgary, the principal investigator have developed the existing ACE program (now called the Thrive Cancer Exercise Program) which offers participants a 12-week exercise oncology program with 2 classes per week. The original ACE study, baseline characteristics, and initial examination of program impact highlight the value of the ACE exercise intervention for ILWBC. This published work has resulted in streamlining ACE to program implementation and evaluation (HREBA.CC-24-0252). With increased clinical referral, the waitlist to the ongoing Thrive Cancer Exercise Program is growing. There is thus a pragmatic need to establish the optimal dose of exercise, to determine if a sustainable model of one class per week is sufficient to garner potential benefits and meet the growing clinical demand, as well as optimize health care costs and savings.
Research Question and Objectives: The purpose of this study is to evaluate the effects of exercise dose in terms of frequencies (one vs. two days per week) in individuals on treatment for colorectal cancer. The impact not only on the individual (potential benefits of exercise), but also in terms of cost will be assessed. In addition, assessments of immunological markers, physical function, QoL, fatigue, symptoms and exercise experience will occur.
Methods: This RCT study is a three-arm, parallel-group trial delivered through the Thrive Cancer Exercise Program at the Arthur J.E. Child Comprehensive Cancer Centre (ACCCC) Stride Centre and Rehab gym. Participants will be randomized (1:1:1) to: 1) Once/week (n = 30); 2) Twice/week for 12 weeks (n = 30); 3) Control-waitlisted to start Thrive Cancer Exercise Program after study completion (n = 30).
ACE-Dose classes will be delivered by Clinical Exercise Physiologists (CEPs) trained to lead high-risk participant classes. The program is a combination of aerobic, resistance, balance, and flexibility exercises delivered in group circuit-style class. The Thrive Cancer Exercise Program current infrastructure and referral process will be used.
Baseline, 12 weeks, 24 weeks and 52 weeks assessments will be done. The following information will be collected: 1) Attendance and Adverse event; 2) Health economics (work and productivity, time and income loss, informal care and daily impact, treatment attendance and travel, out-of-pocket costs, and medications and cost for cancer); 3) Bloodwork conducted by a phlebotomist to assess Immunological markers; 4) Patient-reported outcomes through standardized questionnaires (Quality of life, Fatigue, Symptom management, Exercise Barriers and Facilitators); 5) Physical activity \& function assessments (Subjective Physical activity level, Cardiorespiratory fitness, Musculoskeletal fitness, Flexibility, Balance, and Anthropometrics); 6) Garmin data (step counts per day and heart rate) to assess objective Physical Activity Level; 7) Qualitative interview on Program experience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a three-arm RCT employing a non-inferiority design for the primary comparison between active arms (arms 1 and 2), with superiority comparisons against the waitlist control (arm 3) (i.e. non-inferiority superiority hybrid design).
| Arm | Type | Receives |
|---|---|---|
| Once/week exercise session for 12 weeks (Arm 1) | Experimental | Behavioral: Group Exercise Classes - Arm 1Arm 1 will be supervised by a CEP once a week (e.g. Tuesday or Thursday) at the ACCCC. The exercise program includes aerobic, strength and balance / flexibility exercises for 12 week. |
| Twice/week exercise session for 12 weeks (Arm 2) | Active comparator | Behavioral: Group Exercise Classes - Arm 2Arm 2 will be supervised by a CEP twice a week (e.g. Tuesday and Thursday) at the ACCCC. The exercise program includes aerobic, strength and balance / flexibility exercises for 12 week. |
| Control-waitlisted group (Arm 3) | No intervention | –Standard of care control-waitlisted group to start the Thrive program after 24 weeks on a voluntary basis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (≥18)
- Have a primary biopsy-proven diagnosis of colon or rectal adenocarcinoma and undergoing adjuvant systemic treatment
- Cleared for exercise (PAR-Q+)
- Able to attend scheduled sessions
- Able to provide informed written consent in English.
Key exclusion criteria (7 listed)
- Participants who have completed adjuvant treatment for CRC
- Unstable cardiopulmonary disease
- Uncontrolled hypertension
- Active infection
- Recent autoimmune flare
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 |
|---|---|---|
| Group Exercise Classes - Arm 1Interventional arm 1 complete the supervised 60-min exercise classes for 12 weeks at low-to-moderate intensity, progressing individually (warm-up, aerobic intervals, multi-joint resistance, balance/flexibility cool-down), once-weekly. Sessions are delivered in-person by a CEP at the ACCCC Stride Centre. Attendance, RPE, and any modifications/adverse events are logged each session. In addition to exercise, 5 behaviour components will be covered throughout the program using an "Exercise and Educate" model, to support behaviour change. The trained instructor will build a positive motivational climate utilizing training in health coaching and motivational interviewing. | Behavioural | Once/week exercise session for 12 weeks (Arm 1) |
| Group Exercise Classes - Arm 2Interventional arm 2 complete the supervised 60-min exercise classes for 12 weeks at low-to-moderate intensity, progressing individually (warm-up, aerobic intervals, multi-joint resistance, balance/flexibility cool-down), twice-weekly. Sessions are delivered in-person by a CEP at the ACCCC Stride Centre. Attendance, RPE, and any modifications/adverse events are logged each session. In addition to exercise, 5 behaviour components will be covered throughout the program using an "Exercise and Educate" model, to support behaviour change. The trained instructor will build a positive motivational climate utilizing training in health coaching and motivational interviewing. | Behavioural | Twice/week exercise session for 12 weeks (Arm 2) |
Primary outcome
Proportion of patients in the once per week and twice per week group that achieve an increase of ≥10 MET-h/wk of total physical activity level at 12 weeks.
Time frame: Single time point: 12 weeks
To assess the dose-response effect of exercise frequency (once versus twice weekly) over a 12-week period on clinically meaningful improvements in physical activity level (≥10 MET-h/wk increase over baseline) in patients with early-stage CRC receiving systemic treatment, with the goal of identifying the minimal effective intervention frequency
6 secondary outcomes
Number of participants with exercise-related adverse events with CTCAE standardized reports
Time frame: From enrollment to 24 weeks
Difference in health economic and health care utilization between groups over 52 weeks
Time frame: From enrollment to 52 weeks
Changes from baseline in the PROs at 12 weeks, and at 24- and 52-week follow-ups.
Time frame: From enrollment to the end of the study at 52 weeks
Changes from baseline in anthropometric parameters and fitness level at 12 weeks, and at the 24- and 52-week follow-ups.
Time frame: From enrollment to the end of the study at 52 weeks
Changes from baseline in objective physical activity level at 12 weeks, and at the 24-week follow-up.
Time frame: From enrollment to 24 weeks
Participant experience and perceived tolerability of the ACE-dose program at 12 weeks
Time frame: Single time point: 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 6 Nov 2026.
- Individual participant dataSharing planned: No. No plan at this time to share IPD outside of research team
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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.
S. Nicole Culos-Reed, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Group Exercise Classes - Arm 1 and Group Exercise Classes - Arm 2 in people with Cancer and Colorectal Cancer, run by University of Calgary 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 Nov 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Aude-Marie Foucaut, PhD (403-210-8482, audemarie.foucaut@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients in the once per week and twice per week group that achieve an increase of ≥10 MET-h/wk of total physical activity level at 12 weeks. (time frame: Single time point: 12 weeks). 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 6 Nov 2026.