Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03730818
Other study ID # AQUAFIT-2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date April 30, 2023

Study information

Verified date July 2023
Source Universitat Pompeu Fabra
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date April 30, 2023
Est. primary completion date March 8, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Water-based Exercise Group
The intervention consist will of a water-based exercise protocol
Land-based Exercise Group
The intervention will consist of a land-based exercise protocol

Locations

Country Name City State
Spain Centre Claror - Fundació Marítim Barcelona

Sponsors (3)

Lead Sponsor Collaborator
Universitat Pompeu Fabra Centre Esportiu Claror Marítim, Hospital del Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Recruiting NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2