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

NCT03730818 | Completed

• 1 other identifier: AQUAFIT-2018
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Exercise Therapy; Aquatic Therapy; Health-Related Quality of Life; Cancer-related Fatigue; Exercise Tolerance; Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Exercise Functional Capacity

  Exercise functional capacity from baseline throughout the study period (24 weeks)

• Change in Physical Activity levels

  Physical activity levels from baseline throughout the study period (24 weeks)

• Change in Upper Body Strength

  Upper body strength from baseline throughout the study period (24 weeks)

• Change in Lower Body Strength

  Lower body strength from baseline throughout the study period (24 weeks)

• Change in Health-Related Quality of Life

  Health-related quality of life from baseline throughout the study period (24 weeks)

Study Arms (2)

Water-based Exercise Group

EXPERIMENTAL

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

Land-based Exercise Group

ACTIVE COMPARATOR

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

Interventions

Water-based Exercise Group OTHER

The intervention consist will of a water-based exercise protocol

Water-based Exercise Group

Land-based Exercise Group OTHER

The intervention will consist of a land-based exercise protocol

Land-based Exercise Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Pompeu Fabra: lead
• Hospital del Mar: collaborator
• Centre Esportiu Claror Marítim: collaborator

Study Sites (1)

Centre Claror - Fundació Marítim

Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an assessor-blind study. Physiotherapist in charge of performing the baseline and post-intervention assessment will be blinded to participants allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 5, 2018
• Study Start: September 1, 2020
• Primary Completion: March 8, 2023
• Study Completion: April 30, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)