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

NCT ID: NCT03730818

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-04-30

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
This is an assessor-blind study. Physiotherapist in charge of performing the baseline and post-intervention assessment will be blinded to participants allocation

Study Groups

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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.

Group Type EXPERIMENTAL

Water-based Exercise Group

Intervention Type OTHER

The intervention consist will of a water-based exercise protocol

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.

Group Type ACTIVE_COMPARATOR

Land-based Exercise Group

Intervention Type OTHER

The intervention will consist of a land-based exercise protocol

Interventions

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Water-based Exercise Group

The intervention consist will of a water-based exercise protocol

Intervention Type OTHER

Land-based Exercise Group

The intervention will consist of a land-based exercise protocol

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital del Mar

OTHER

Sponsor Role collaborator

Centre Esportiu Claror Marítim

UNKNOWN

Sponsor Role collaborator

Universitat Pompeu Fabra

OTHER

Sponsor Role lead

Responsible Party

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Raquel Sebio

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre Claror - Fundació Marítim

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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AQUAFIT-2018

Identifier Type: -

Identifier Source: org_study_id

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