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

Study Overview
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Water-based Exercise Group
* Other: Land-based Exercise Group


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Water-based Exercise Group<br>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<br>* The intervention consist will of a water-based exercise protocol<br>|
| Active Comparator: Land-based Exercise Group<br>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<br>* The intervention will consist of a land-based exercise protocol<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise Therapy, Aquatic Therapy, Health-Related Quality of Life, Cancer-related Fatigue, Exercise Tolerance, Physical Activity