Physical Exercise Benefits for Cancer Patients
February 22, 2024 updated by: Elena Garcia Roca, Universitat Jaume I
Physical Exercise Benefits in Breast Cancer Patients Undergoing Treatment
The purpose of the study was to analyze the effect of a synchronous-supervised online home-based group during a 6-month exercise program on physical fitness, body composition and adherence compared to an exercise recommendation group of patients undergoing breast cancer treatment without supervision.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: M. Elena Garcia-Roca, MSc
- Phone Number: +34 629112367
- Email: garciroc@uji.es
Study Contact Backup
- Name: Eladio J Collado-Boira, PhD
- Phone Number: +34 606133368
- Email: colladoe@uji.es
Study Locations
-
-
Castellón
-
Castellón De La Plana, Castellón, Spain, 12071
- Recruiting
- Jaume I University
-
Contact:
- Eladio J Collado-Boira, PhD
- Phone Number: +34 606133368
- Email: colladoe@uji.es
-
Contact:
- Elena Garcia Roca, MSc
- Phone Number: +34 629112367
- Email: garciroc@uji.es
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18 years old or older
- Diagnosted with breast cancer
- Undergoing cancer treatment
- No medical contraindications
Exclusion Criteria:
- Medical contraindications for sport practice
- Refusal to participate in the study
- Comorbilities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Synchronous-supervised online home-baased group
Group following a supervised exercise program with an exercise cancer specialist
|
An online exercise program combining endurance and strength training
|
|
Active Comparator: Exercise recommendation group
Group following general recommendations of physical exercise
|
General recommendation about physical exercise.
No supervised
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiorrespiratory fitness
Time Frame: 24 weeks
|
6 minutes walking test was performed in a 50 meter circuit.
Meters completed during 6 minutes were recorded.
|
24 weeks
|
|
Strength - Chair Stand (repetitions)
Time Frame: 24 weeks
|
Chair stand test was performed.
Number of repetitions performed during 30 seconds was recorded.
|
24 weeks
|
|
Flexibility
Time Frame: 24 weeks
|
Sit and Reach (centimeters): sitted and with stretched legs, the patient has to move a piece of wood on a bench.
The centimeters moved by the patients are recorded
|
24 weeks
|
|
Incidence of treatments on quality of live assessed by EORTIC QLQ-C30
Time Frame: 24 weeks
|
QLQ-C30 questionnaire with 30 items was used to record the quality of life of the patients.
Each item has a scale from 1 to 4, being 1 the lowest and 4 the highest outcome.
|
24 weeks
|
|
Adherence
Time Frame: 24 weeks
|
Minutes on each training session were recorded to control the adherence.
|
24 weeks
|
|
Rating of perceived exertion
Time Frame: 24 weeks
|
A Borg Scale (1-10) was used to control the intensity of the sessions, being 1 the lowest intensity and 10 the highest intensity.
|
24 weeks
|
|
Strength - Hand Grip (Kilograms)
Time Frame: 24 weeks
|
Hand Grip (kilograms): a dynamometer (Grip Strength Dynamometer, Takker TKK, Tokio, Japón) was used to record hand grip.
|
24 weeks
|
|
Strength - Squat Jump (height in centimeters)
Time Frame: 24 weeks
|
Squat Jump (centimeters): a contact platform (Chronojump Boscosystem, Barcelona, Spain) was used to record the height of the jump in centimeters.
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: M. Elena Garcia-Roca, MSc, Jaume I University
- Study Director: Eladio J. Collado-Boira, PhD, Jaume I University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 5, 2021
Primary Completion (Estimated)
July 27, 2024
Study Completion (Estimated)
July 30, 2025
Study Registration Dates
First Submitted
January 30, 2024
First Submitted That Met QC Criteria
February 22, 2024
First Posted (Actual)
February 23, 2024
Study Record Updates
Last Update Posted (Actual)
February 23, 2024
Last Update Submitted That Met QC Criteria
February 22, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Elena Garcia Roca
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.