Breast Cancer Clinical Trial
Official title:
Effects of Water-based Versus Land-based Exercise on Cancer-related Fatigue and Functional Capacity in Breast Cancer Survivors
Verified date | July 2023 |
Source | Universitat Pompeu Fabra |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Physical activity and exercise have demonstrated to be an integral part of the cancer-continuum care. Despite strong evidence suggesting that both endurance and strength training should be encourage in cancer patients, there is still controversy regarding exercise dosage, frequency, volume and optimal environment of delivery. In this randomised controlled trial we aim to compare water-based versus land-based exercise in breast cancer survivors to decrease cancer-related fatigue (CRF), improve Health-Related Quality of Life (HRQoL), exercise tolerance, muscle strength and physical activity levels.
Status | Completed |
Enrollment | 28 |
Est. completion date | April 30, 2023 |
Est. primary completion date | March 8, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Breast Cancer patients post cancer treatment (at least for 6 months) - Cancer-free at the time of recruitment - Signed informed consent - Living in the metropolitan area of Barcelona Exclusion Criteria: - Fear of water - Receiving cancer therapy at the time of recruitment - Not willing to participate/Refuse to sign informed consent - Physical of cognitive impairments precluding the patient to perform the exercises |
Country | Name | City | State |
---|---|---|---|
Spain | Centre Claror - Fundació Marítim | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Universitat Pompeu Fabra | Centre Esportiu Claror Marítim, Hospital del Mar |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Cancer-related Fatigue | Cancer-related fatigue as measure with the specific subscale found in the EORTC QLQ C30 questionnaire specifically designed for a cancer population | Cancer-related fatigue from baseline throughout the study period (24 weeks) | |
Secondary | Change in Exercise Functional Capacity | 6 Minute Walk Test performed accordingly to international guidelines | Exercise functional capacity from baseline throughout the study period (24 weeks) | |
Secondary | Change in Physical Activity levels | Physical Activity in METS-hour/week and minutes/week assessed with a triaxial accelerometer (Actigraph wgt3x-bt) | Physical activity levels from baseline throughout the study period (24 weeks) | |
Secondary | Change in Upper Body Strength | Upper body muscle strength measured with a hand-held dynamometer and a handgrip test | Upper body strength from baseline throughout the study period (24 weeks) | |
Secondary | Change in Lower Body Strength | Lower body muscle strength measured with a hand-held dynamometer (leg extension) and the sit-to-stand test | Lower body strength from baseline throughout the study period (24 weeks) | |
Secondary | Change in Health-Related Quality of Life | HRQoL measured with the EORTC QLQ C30 questionnaire | Health-related quality of life from baseline throughout the study period (24 weeks) |
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