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Completed

NCT Number: NCT03730818

Water-based Versus Land-based Exercise for 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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Claror - Fundació Marítim

Barcelona, 08003, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water-based Exercise Group

Other

The intervention consist will of a water-based exercise protocol

Land-based Exercise Group

Other

The intervention will consist of a land-based exercise protocol

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitat Pompeu Fabra

Other

Collaborators

  • Centre Esportiu Claror Marítim
  • Hospital del Mar

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 5, 2018
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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