Cancer, BreastNCT06275321
Physical Exercise Benefits for Cancer Patients
A study testing Synchronous-supervised online home-based group and Exercise recommendation group in people with Cancer, Breast and Sports Physical Therapy, run by Universitat Jaume I at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cancer, Breast, Sports Physical Therapy
- What is being tested?
- Synchronous-supervised online home-based group and Exercise recommendation group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 5 Nov 2021to 30 Jul 2025
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older
- Diagnosted with breast cancer
- Undergoing cancer treatment
- No medical contraindications
Who cannot join
- Medical contraindications for sport practice
- Refusal to participate in the study
- Comorbilities
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Jaume I University
Castellon, Castellón, 12071
Elena Garcia Roca, MSc, +34 629112367, garciroc@uji.es
Eladio J Collado-Boira, PhD, +34 606133368, colladoe@uji.es
About this study
Official title: 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.
- Conditions
- Cancer, Breast, Sports Physical Therapy
- Being tested
- Synchronous-supervised online home-based group, Exercise recommendation group
- Keywords
- Oncology, Quality of live, Physical exercise, Physical activity, Physical fitness
- Medical subject headings
- Breast Neoplasms, Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronous-supervised online home-based groupOther
An online exercise program combining endurance and strength training
Exercise recommendation groupOther
General recommendation about physical exercise. No supervised
| Study group | Role | What they receive |
|---|---|---|
| Synchronous-supervised online home-baased group | Experimental | Group following a supervised exercise program with an exercise cancer specialist Receives: Other: Synchronous-supervised online home-based group |
| Exercise recommendation group | Active comparator | Group following general recommendations of physical exercise Receives: Other: Exercise recommendation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorrespiratory fitness
6 minutes walking test was performed in a 50 meter circuit. Meters completed during 6 minutes were recorded.
Measured: 24 weeks
Strength - Chair Stand (repetitions)
Chair stand test was performed. Number of repetitions performed during 30 seconds was recorded.
Measured: 24 weeks
Flexibility
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
Measured: 24 weeks
Incidence of treatments on quality of live assessed by EORTIC QLQ-C30
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.
Measured: 24 weeks
Adherence
Minutes on each training session were recorded to control the adherence.
Measured: 24 weeks
Rating of perceived exertion
A Borg Scale (1-10) was used to control the intensity of the sessions, being 1 the lowest intensity and 10 the highest intensity.
Measured: 24 weeks
Strength - Hand Grip (Kilograms)
Hand Grip (kilograms): a dynamometer (Grip Strength Dynamometer, Takker TKK, Tokio, Japón) was used to record hand grip.
Measured: 24 weeks
Strength - Squat Jump (height in centimeters)
Squat Jump (centimeters): a contact platform (Chronojump Boscosystem, Barcelona, Spain) was used to record the height of the jump in centimeters.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start5 Nov 2021
- Primary completion27 Jul 2024 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BreastStudies 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
- Crossover
- Model description
- A prospective ramonized clinical trial with two groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Garcia Roca, Universitat Jaume I
- Investigators
- M. Elena Garcia-Roca, MSc, Principal investigator, Universitat Jaume IEladio J. Collado-Boira, PhD, Study director, Universitat Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275321
- Sponsor's protocol ID
- Elena Garcia Roca
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 23 Feb 2024
- 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 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise Benefits in Breast Cancer Patients Undergoing Treatment
- ClinicalTrials.gov ID
- NCT06275321
- Acronym / sponsor ID
- Elena Garcia Roca
- Conditions
- Cancer, Breast, Sports Physical Therapy
- Keywords
- Oncology, Quality of live, Physical exercise, Physical activity, Physical fitness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 27 Jul 2024 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 23 Feb 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A prospective ramonized clinical trial with two groups
| Arm | Type | Receives |
|---|---|---|
| Synchronous-supervised online home-baased group | Experimental | Other: Synchronous-supervised online home-based groupGroup following a supervised exercise program with an exercise cancer specialist |
| Exercise recommendation group | Active comparator | Other: Exercise recommendation groupGroup following general recommendations of physical exercise |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or older
- Diagnosted with breast cancer
- Undergoing cancer treatment
- No medical contraindications
Key exclusion criteria (3 listed)
- Medical contraindications for sport practice
- Refusal to participate in the study
- Comorbilities
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 |
|---|---|---|
| Synchronous-supervised online home-based groupAn online exercise program combining endurance and strength training | Other | Synchronous-supervised online home-baased group |
| Exercise recommendation groupGeneral recommendation about physical exercise. No supervised | Other | Exercise recommendation group |
Primary outcome
Cardiorrespiratory fitness
Time frame: 24 weeks
6 minutes walking test was performed in a 50 meter circuit. Meters completed during 6 minutes were recorded.
Strength - Chair Stand (repetitions)
Time frame: 24 weeks
Chair stand test was performed. Number of repetitions performed during 30 seconds was recorded.
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
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.
Adherence
Time frame: 24 weeks
Minutes on each training session were recorded to control the adherence.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- 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.
M. Elena Garcia-Roca, MSc principal investigator
Universitat Jaume I
Eladio J. Collado-Boira, PhD study director
Universitat Jaume I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synchronous-supervised online home-based group and Exercise recommendation group in people with Cancer, Breast and Sports Physical Therapy, run by Universitat Jaume I 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 3 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: status not confirmed, as of the sponsor's last update on 23 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M. Elena Garcia-Roca, MSc (+34 629112367, garciroc@uji.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorrespiratory fitness (time frame: 24 weeks). The study lists 8 primary outcomes in all. 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 23 Feb 2024.