Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2156 participants
INTERVENTIONAL
2023-07-01
2033-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exercise
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).
Exercise Programme
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.
Control
The usual care group.
Control
Usual care group.
Interventions
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Exercise Programme
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.
Control
Usual care group.
Eligibility Criteria
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Inclusion Criteria
* Patients who have undergone curative breast surgery
* Patients who have received (neo)adjuvant chemotherapy (if given) and/or radiotherapy (if given)
* Females aged 21 years and older
* ≤ 8 weeks from breast surgery, or the last adjuvant chemotherapy or radiotherapy session, whichever is latest.
Exclusion Criteria
* Major medical problems that are deemed by the investigator to be unsuitable for enrollment.
21 Years
99 Years
FEMALE
No
Sponsors
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Singapore Cancer Society
OTHER
Genome Institute of Singapore
OTHER
National University of Singapore
OTHER
Singapore General Hospital
OTHER
National Cancer Centre, Singapore
OTHER
Responsible Party
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Principal Investigators
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Dr Elaine LIM, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Centre, Singapore
Locations
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National University Hospital
Singapore, , Singapore
National Cancer Centre
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BREXINT
Identifier Type: -
Identifier Source: org_study_id
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