Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Singapore Cancer Society | OTHER |
| Genome Institute of Singapore | OTHER |
| National University of Singapore | OTHER |
| Singapore General Hospital |
Not provided
Not provided
Not provided
Not provided
This is a 24-week exercise programme consisting of aerobic exercise and muscle strength training, 3 sessions per week. The first 9 sessions are supervised by physiotherapists in person, followed by 63 sessions monitored remotely (video) or supervised by trainers at ActiveSG (Sport Singapore) gyms.
This is a multi-centre, randomised controlled study of a 6-month (24-week) exercise programme versus observation in 2156 early stage and locally advanced breast cancer patients who have undergone curative breast surgery, and who have completed (neo)adjuvant chemotherapy (if given) or radiotherapy (if given). Patients are stratified by centre (NCC/SGH, NUH), menopausal status, ER/PR status, body fat/muscle ratio.
Cardiorespiratory fitness, muscle strength, level of routine daily physical activity, body fat/muscle ratio are monitored during the study period.
Blood is collected at baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks, then annually for 4 times.
Questionnaires are periodically conducted to assess quality of life (QoL). A food diary is kept.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | The exercise intervention group will undergo an aerobic exercise and strength training programme, comprising 3 sessions per week, spanning 24 weeks (total: 3x24=72 sessions). |
|
| Control | Experimental | The usual care group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Programme | Behavioral | Aerobic exercise consists of 20-minute brisk walks or jogs (5-6 km/h) on the treadmill each session, reaching a heart rate corresponding to 50%-70% of the patient's VO2max (VO2max is determined before embarking on the exercise programme). Study participants are expected to aim for 50% VO2max at the start of the exercise programme, and gradually increasing to 70% VO2max in subsequent exercise sessions. Strength training comprises a series of circuit resistance exercises targeting the major muscle groups. Patients will perform 2-4 sets of these exercises each session, 8-10 repetitions per set. Both aerobic exercise and strength training are done in the same session. With warm-up and cool-down, each session is estimated to take up 1 hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival (DFS) | From the date of randomization to when an event, i.e. relapse, has occurred. | Up to 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | From the date of randomization to when an event, i.e. death, has occurred. | Up to 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Body fat/muscle ratio. | Body fat mass (in grams) divided by body muscle mass (in grams). | Week 0, Week 8, Week 16 and Week 24. |
| Changes in absolute and relative VO2. | Changes in absolute (L/min) and relative VO2 (mL/kg/min) at 8, 16 and 24 weeks from baseline. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Elaine LIM, MD, PhD | Contact | +65 64368000 | elaine.lim.hsuen@singhealth.com.sg | |
| Catherine CELES | Contact | catherine.celes@nccs.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Dr Elaine LIM, MD, PhD | National Cancer Centre, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Recruiting | Singapore | 119074 | Singapore |
Once data is available, only de-identified IPD will be shared to collaborators.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| OTHER |
Eligible patients will be randomised into 2 groups: exercise (intervention group, N = 1078) and usual care (control group, N = 1078). The exercise intervention group will undergo an aerobic exercise and strength training programme.
Not provided
Not provided
Not provided
Not provided
|
| Control | Behavioral | Usual care group. |
|
| Week 8, Week 16 and Week 24. |
| Changes in heart rate at rest and during CPET. | Changes in heart rate (HR, beats/min) at rest and during CPET, at 8, 16 and 24 weeks from baseline. | Week 8, Week 16 and Week 24. |
| Changes in oxygen pulse (VO2/HR) during CPET. | Changes in oxygen pulse (VO2/HR) during CPET, at 8, 16, and 24 weeks from baseline. | Week 8, Week 16 and Week 24. |
| Changes in respiratory exchange ratio (RER) during CPET. | Changes in respiratory exchange ratio (RER, unitless) during CPET, at 8, 16, and 24 weeks from baseline | Week 8, Week 16 and Week 24. |
| Changes in weight lifted 10 repetition maximum. | Changes in weight lifted 10 repetition maximum (10-RM, Kg) for: a. Chest press; b. Latissimus pull-down; c. 2-arm curl; and d. Leg press. | Week 0, Week 8, Week 16 and Week 24. |
| Changes in absolute fat mass and relative fat mass from baseline. | Changes in absolute fat mass (kg) and relative fat mass (%) at 8, 16, and 24 weeks from baseline. | Week 8, Week 16 and Week 24. |
| Changes in absolute lean mass and relative lean mass from baseline. | Changes in absolute lean mass (kg) and relative lean mass (%) at 8, 16, and 24 weeks from baseline. | Week 8, Week 16 and Week 24. |
| Changes in absolute and relative bone mineral density (BMD) at 8, 16, and 24 weeks from baseline. | Changes in absolute and relative bone mineral density (BMD, in g/cm^2) at 8, 16, and 24 weeks from baseline. | Week 8, Week 16 and Week 24. |
| National Cancer Centre | Recruiting | Singapore | 168583 | Singapore |
| Singapore General Hospital | Recruiting | Singapore | 169608 | Singapore |
|
| D017437 |
| Skin and Connective Tissue Diseases |