Water-based Versus Land-based Exercise for Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT03730818
• Lead Sponsor: Universitat Pompeu Fabra

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-01
• Study First Submitted QC: 2018-11-02
• Study First Posted: 2018-11-05
• Study Start: 2020-09-01
• Primary Completion: 2023-03-08
• Study Completion: 2023-04-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Cancer-related Fatigue	Cancer-related fatigue from baseline throughout the study period (24 weeks)	Cancer-related fatigue as measure with the specific subscale found in the EORTC QLQ C30 questionnaire specifically designed for a cancer population

Secondary Outcome Measures

Name	Time	Method
Change in Exercise Functional Capacity	Exercise functional capacity from baseline throughout the study period (24 weeks)	6 Minute Walk Test performed accordingly to international guidelines
Change in Physical Activity levels	Physical activity levels from baseline throughout the study period (24 weeks)	Physical Activity in METS-hour/week and minutes/week assessed with a triaxial accelerometer (Actigraph wgt3x-bt)
Change in Upper Body Strength	Upper body strength from baseline throughout the study period (24 weeks)	Upper body muscle strength measured with a hand-held dynamometer and a handgrip test
Change in Lower Body Strength	Lower body strength from baseline throughout the study period (24 weeks)	Lower body muscle strength measured with a hand-held dynamometer (leg extension) and the sit-to-stand test
Change in Health-Related Quality of Life	Health-related quality of life from baseline throughout the study period (24 weeks)	HRQoL measured with the EORTC QLQ C30 questionnaire

Trial Locations

Locations (1)

Centre Claror - Fundació Marítim; 🇪🇸 Barcelona, Spain