Breast CancerNCT03730818
Water-based Versus Land-based Exercise for Breast Cancer Survivors
A study testing Water-based Exercise Group and Land-based Exercise Group in people with Breast Cancer, run by Universitat Pompeu Fabra at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Water-based Exercise Group and Land-based Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Water-based Versus Land-based Exercise on Cancer-related Fatigue and Functional Capacity in 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.
- Conditions
- Breast Cancer
- Being tested
- Water-based Exercise Group, Land-based Exercise Group
- Keywords
- Exercise Therapy, Aquatic Therapy, Health-Related Quality of Life, Cancer-related Fatigue, Exercise Tolerance, Physical Activity
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-based Exercise GroupOther
The intervention consist will of a water-based exercise protocol
Land-based Exercise GroupOther
The intervention will consist of a land-based exercise protocol
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Land-based Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Cancer-related fatigue from baseline throughout the study period (24 weeks)
Secondary outcomes (5)
Change in Exercise Functional Capacity
6 Minute Walk Test performed accordingly to international guidelines
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Health-related quality of life from baseline throughout the study period (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start1 Sep 2020
- Primary completion8 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Pompeu Fabra
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital del Mar, Centre Esportiu Claror Marítim
- Responsible party
- Principal investigator, Raquel Sebio, Universitat Pompeu Fabra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730818
- Sponsor's protocol ID
- AQUAFIT-2018
- Status last verified
- Jul 2023
- First submitted
- 1 Nov 2018
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Water-based Versus Land-based Exercise on Cancer-related Fatigue and Functional Capacity in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03730818
- Acronym / sponsor ID
- AQUAFIT-2018
- Conditions
- Breast Cancer
- Keywords
- Exercise Therapy, Aquatic Therapy, Health-Related Quality of Life, Cancer-related Fatigue, Exercise Tolerance, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universitat Pompeu FabraUniversity, hospital or other
- Collaborators
- Hospital del Mar, Centre Esportiu Claror Marítim
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water-based Exercise Group | Experimental | Other: Water-based Exercise GroupThe 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. |
| Land-based Exercise Group | Active comparator | Other: Land-based Exercise GroupThe 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water-based Exercise GroupThe intervention consist will of a water-based exercise protocol | Other | Water-based Exercise Group |
| Land-based Exercise GroupThe intervention will consist of a land-based exercise protocol | Other | Land-based Exercise Group |
Primary outcome
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
5 secondary outcomes
Change in Exercise Functional Capacity
Time frame: Exercise functional capacity from baseline throughout the study period (24 weeks)
Change in Physical Activity levels
Time frame: Physical activity levels from baseline throughout the study period (24 weeks)
Change in Upper Body Strength
Time frame: Upper body strength from baseline throughout the study period (24 weeks)
Change in Lower Body Strength
Time frame: Lower body strength from baseline throughout the study period (24 weeks)
Change in Health-Related Quality of Life
Time frame: Health-related quality of life from baseline throughout the study period (24 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water-based Exercise Group and Land-based Exercise Group in people with Breast Cancer, run by Universitat Pompeu Fabra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Cancer-related Fatigue (time frame: Cancer-related fatigue from baseline throughout the study period (24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.