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

Effects of Water-based Versus Land-based Exercise on Cancer-related Fatigue and Functional Capacity in Breast Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Water-based Exercise Group; Other: Land-based Exercise Group

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Centre Claror - Fundació Marítim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Water-based Exercise Group; The intervention consist will of a water-based exercise protocol
Active Comparator: 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.	Other: Land-based Exercise Group; The intervention will consist of a land-based exercise protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Universitat Pompeu Fabra
• Collaborators: Hospital del Mar; Centre Esportiu Claror Marítim

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): March 8, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: November 2, 2018
• First Posted (Actual): November 5, 2018

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise Therapy; Exercise Tolerance; Health-Related Quality of Life; Cancer-related Fatigue; Aquatic Therapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: AQUAFIT-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No