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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Water-based Exercise Group; Other: Land-based Exercise Group

• 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

Arm && Interventions

Group	Intervention	Description
Water-based Exercise Group	Water-based Exercise Group	The Water-based Exercise Group will compromise participants attending a 2 weekly exercise intervention each session lasting 1 hour for 12 weeks. Each session will consist of: * 10 minutes of warm-up: general mobilisation, walking, active stretching * 40 minutes of global training: 20 minutes of endurance exercise and 20 minutes of resistance exercises targeting large main muscle groups involved in daily life activities (squats, lateral hip abduction, row, etc.) using body weight and elastic bands * 10 minutes of cooling down: stretching, breathing exercises and relaxation Intensity will be monitored with the modified Borg Scale to maintain a 5 - 6 level of exertion during the first 5 weeks and progressively increase to a 6 - 7 level for the following weeks.
Land-based Exercise Group	Land-based Exercise Group	The land-based exercise group will attend as well 2 weekly sessions lasting 1 hour each for 12 weeks. Each session will consist of the same structure as the Water-based Exercise Group including: * 10 minutes warm up * 40 minutes of global training (20 minutes of endurance exercise and 20 minutes of resistance training) * 10 minutes cool down. The exercises will be adapted from the water-based exercise group to match the requirements on the water-based exercise group. Intensity will be monitored with the Perceived Rate of Exertion Scale (modified Borg Scale, Borg 1982) to maintain a 5 - 6 level of exertion during the first 5 weeks and progressively increase to a 6 - 7 level for the following weeks.

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