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

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ClinicalTrials.gov Identifier: NCT03730818
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : July 7, 2021
Sponsor:
Collaborators:
Hospital del Mar
Centre Esportiu Claror Marítim
Information provided by (Responsible Party):
Raquel Sebio, Universitat Pompeu Fabra

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Water-based Exercise Group Other: Land-based Exercise Group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: This is an assessor-blind study. Physiotherapist in charge of performing the baseline and post-intervention assessment will be blinded to participants allocation
Primary Purpose: Treatment
Official Title: Effects of Water-based Versus Land-based Exercise on Cancer-related Fatigue and Functional Capacity in Breast Cancer Survivors
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Cancer-related Fatigue [ Time Frame: 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 :
  1. Change in Exercise Functional Capacity [ Time Frame: Exercise functional capacity from baseline throughout the study period (24 weeks) ]
    6 Minute Walk Test performed accordingly to international guidelines

  2. Change in Physical Activity levels [ Time Frame: 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)

  3. Change in Upper Body Strength [ Time Frame: 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

  4. Change in Lower Body Strength [ Time Frame: 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

  5. Change in Health-Related Quality of Life [ Time Frame: Health-related quality of life from baseline throughout the study period (24 weeks) ]
    HRQoL measured with the EORTC QLQ C30 questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730818


Contacts
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Contact: Raquel Sebio, PhD +34679336288 rsebio@tecnocampus.cat
Contact: Esther Mur, PhD +34677363217 emur@tecnocampus.cat

Locations
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Spain
Centre Claror - Fundació Marítim Recruiting
Barcelona, Spain, 08003
Contact: Esther Mur-Gimeno, PhD         
Sponsors and Collaborators
Universitat Pompeu Fabra
Hospital del Mar
Centre Esportiu Claror Marítim
More Information
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Responsible Party: Raquel Sebio, Principal Investigator, Universitat Pompeu Fabra
ClinicalTrials.gov Identifier: NCT03730818    
Other Study ID Numbers: AQUAFIT-2018
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raquel Sebio, Universitat Pompeu Fabra:
Exercise Therapy
Aquatic Therapy
Health-Related Quality of Life
 Cancer-related Fatigue
Exercise Tolerance
Physical Activity
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases