Female Breast CancerIO/2024NCT06618690
Exercise Program on Pain, Physical Function, and Quality of Life in Breast Cancer Survivors
A study testing Exercise program in people with Female Breast Cancer, run by Universidad de Burgos at 1 site in Spain.
Trial summary
The purpose of this project is to develop a randomized clinical trial to determine the efficacy of a supervised exercise program on pain, physical function and quality of life in female breast cancer survivors Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Female Breast Cancer
- What is being tested?
- Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteSpain
- Study dates
- 10 Sep 2024to 2 Apr 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women between 18 and 65 years of age,
- women with oncologic treatment completed less than 3 months ago,
- women without metastasis,
- women without pathologies that contraindicate exercise,
- women who have agreed to sign the informed consent form
Who cannot join
- not attending scheduled sessions to instruct on the exercises to be performed, - being part of other studies,
- undergoing another type of therapy
- pregnancy patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Supervised Exercise Program on Pain, Physical Function, and Quality of Life in Breast Cancer Survivors: Protocol for a Randomized Clinical Trial
The purpose of this project is to develop a randomized clinical trial to determine the efficacy of a supervised exercise program on pain, physical function and quality of life in female breast cancer survivors
Read the detailed description
A randomized, double-blind, clinical trial will be conducted with 325 participants. The intervention group will receive a supervised exercise program for 12 weeks, while the control group will receive no intervention. Participants\' pain, physical function and quality of life will be assessed at baseline, post-intervention and 12 weeks post-intervention.
- Conditions
- Female Breast Cancer
- Being tested
- Exercise program
- Keywords
- breast cancer, exercise, quality of life, muscle strength
- 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.
Exercise programOther
A supervised training plan will be carried out for 12 weeks with a frequency of 3 sessions per week with a duration of 60 minutes, an ideal estimate according to the meta-analysis of Montaño-Rojas et al. The first two weeks the group exercises will be performed to familiarize the participants with the exercises and then each participant will perform them at home with a review every two weeks to assess the increase of the load.
The exercises and loads included in this treatment plan have been designed and modified based on previous clinical trials. The training plan will work upper limbs, lower limbs and trunk. All sessions begin with a general warm-up, which will be previously instructed to the participants, in which the heart rate will be increased (see Multimedia Appendix 1). After a two-minute break, the specific block of each session will begin (see Table 1 and Multimedia Appendix 1). All exercises will be performed with dumbbells, elastic bands and a ball.
| Study group | Role | What they receive |
|---|---|---|
| Grupo experimental | Experimental | The participants will be recruited through the oncologists of the Hospital Universitario Torrecárdenas (Almería). The proposal will be carried out in the intervention group (group 1), while the control group (group 2) will undergo the conventional recommendations indicated for this type of patients. Receives: Other: Exercise program |
| group control | No intervention | The participants will be recruited through the oncologists of the Hospital Universitario Torrecárdenas (Almería). The proposal will be carried out in the intervention group (group 1), while the control group (group 2) will undergo the conventional recommendations indicated for this type of patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
repeated measures ANOVA
the range of motion, tone and muscle strength of the group will be measured in 3 measures over the 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Sep 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion2 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Female 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Burgos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618690
- Sponsor's protocol ID
- IO/2024
- Other IDs
- IO/2024
- Acronym
- IO/2024
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A randomized, double-blind, clinical trial will be conducted with 325 participants. The intervention group will receive a supervised exercise program for 12 weeks, while the control group will receive no intervention. Participants\' pain, physical function and quality of life will be assessed at baseline, post-intervention and 12 weeks post-intervention.
Publications
Iwase T, Wang X, Shrimanker TV, Kolonin MG, Ueno NT. Body composition and breast cancer risk and treatment: mechanisms and impact. Breast Cancer Res Treat. 2021 Apr;186(2):273-283. doi: 10.1007/s10549-020-06092-5. Epub 2021 Jan 21.
PubMed 33475878Michels D, Konig S, Heckel A. Effects of combined exercises on shoulder mobility and strength of the upper extremities in breast cancer rehabilitation: a 3-week randomized controlled trial. Support Care Cancer. 2023 Sep 1;31(9):550. doi: 10.1007/s00520-023-07959-1.
PubMed 37656241Tuchler A, De Pauw A, Ernst C, Anota A, Lakeman IMM, Dick J, van der Stoep N, van Asperen CJ, Maringa M, Herold N, Blumcke B, Remy R, Westerhoff A, Stommel-Jenner DJ, Frouin E, Richters L, Golmard L, Kutting N, Colas C, Wappenschmidt B, Rhiem K, Devilee P, Stoppa-Lyonnet D, Schmutzler RK, Hahnen E. Clinical implications of incorporating genetic and non-genetic risk factors in CanRisk-based breast cancer risk prediction. Breast. 2024 Feb;73:103615. doi: 10.1016/j.breast.2023.103615. Epub 2023 Nov 29.
PubMed 38061307Garcia-Molina J, Saiz-Vazquez O, Santamaria-Vazquez M, Ortiz-Huerta JH. Efficacy of a Supervised Exercise Program on Pain, Physical Function, and Quality of Life in Patients With Breast Cancer: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2025 Mar 12;14:e63891. doi: 10.2196/63891.
PubMed 40073395
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Supervised Exercise Program on Pain, Physical Function, and Quality of Life in Breast Cancer Survivors: Protocol for a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06618690
- Acronym / sponsor ID
- IO/2024 / IO/2024
- Conditions
- Female Breast Cancer
- Keywords
- breast cancer, exercise, quality of life, muscle strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Universidad de BurgosUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 2 Apr 2025 (estimated)
- First posted
- 1 Oct 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 this project is to develop a randomized clinical trial to determine the efficacy of a supervised exercise program on pain, physical function and quality of life in female breast cancer survivors
Detailed description
A randomized, double-blind, clinical trial will be conducted with 325 participants. The intervention group will receive a supervised exercise program for 12 weeks, while the control group will receive no intervention. Participants\' pain, physical function and quality of life will be assessed at baseline, post-intervention and 12 weeks post-intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grupo experimental | Experimental | Other: Exercise programThe participants will be recruited through the oncologists of the Hospital Universitario Torrecárdenas (Almería). The proposal will be carried out in the intervention group (group 1), while the control group (group 2) will undergo the conventional recommendations indicated for this type of patients. |
| group control | No intervention | –The participants will be recruited through the oncologists of the Hospital Universitario Torrecárdenas (Almería). The proposal will be carried out in the intervention group (group 1), while the control group (group 2) will undergo the conventional recommendations indicated for this type of patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- women between 18 and 65 years of age,
- women with oncologic treatment completed less than 3 months ago,
- women without metastasis,
- women without pathologies that contraindicate exercise,
- women who have agreed to sign the informed consent form
Key exclusion criteria (3 listed)
- not attending scheduled sessions to instruct on the exercises to be performed, - being part of other studies,
- undergoing another type of therapy
- pregnancy patients.
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 |
|---|---|---|
| Exercise programA supervised training plan will be carried out for 12 weeks with a frequency of 3 sessions per week with a duration of 60 minutes, an ideal estimate according to the meta-analysis of Montaño-Rojas et al. The first two weeks the group exercises will be performed to familiarize the participants with the exercises and then each participant will perform them at home with a review every two weeks to assess the increase of the load. The exercises and loads included in this treatment plan have been designed and modified based on previous clinical trials. The training plan will work upper limbs, lower limbs and trunk. All sessions begin with a general warm-up, which will be previously instructed to the participants, in which the heart rate will be increased (see Multimedia Appendix 1). After a two-minute break, the specific block of each session will begin (see Table 1 and Multimedia Appendix 1). All exercises will be performed with dumbbells, elastic bands and a ball. | Other | Grupo experimental |
Primary outcome
repeated measures ANOVA
Time frame: 12 weeks
the range of motion, tone and muscle strength of the group will be measured in 3 measures over the 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 33475878Iwase T, Wang X, Shrimanker TV, Kolonin MG, Ueno NT. Body composition and breast cancer risk and treatment: mechanisms and impact. Breast Cancer Res Treat. 2021 Apr;186(2):273-283. doi: 10.1007/s10549-020-06092-5. Epub 2021 Jan 21.
- Background: PubMed 37656241Michels D, Konig S, Heckel A. Effects of combined exercises on shoulder mobility and strength of the upper extremities in breast cancer rehabilitation: a 3-week randomized controlled trial. Support Care Cancer. 2023 Sep 1;31(9):550. doi: 10.1007/s00520-023-07959-1.
- Background: PubMed 38061307Tuchler A, De Pauw A, Ernst C, Anota A, Lakeman IMM, Dick J, van der Stoep N, van Asperen CJ, Maringa M, Herold N, Blumcke B, Remy R, Westerhoff A, Stommel-Jenner DJ, Frouin E, Richters L, Golmard L, Kutting N, Colas C, Wappenschmidt B, Rhiem K, Devilee P, Stoppa-Lyonnet D, Schmutzler RK, Hahnen E. Clinical implications of incorporating genetic and non-genetic risk factors in CanRisk-based breast cancer risk prediction. Breast. 2024 Feb;73:103615. doi: 10.1016/j.breast.2023.103615. Epub 2023 Nov 29.
- Derived from this study: PubMed 40073395Garcia-Molina J, Saiz-Vazquez O, Santamaria-Vazquez M, Ortiz-Huerta JH. Efficacy of a Supervised Exercise Program on Pain, Physical Function, and Quality of Life in Patients With Breast Cancer: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2025 Mar 12;14:e63891. doi: 10.2196/63891.
- Individual participant dataSharing planned: No. A randomized, double-blind, clinical trial will be conducted with 325 participants. The intervention group will receive a supervised exercise program for 12 weeks, while the control group will receive no intervention. Participants\' pain, physical function and quality of life will be assessed at baseline, post-intervention and 12 weeks post-intervention.
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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 Exercise program in people with Female Breast Cancer, run by Universidad de Burgos 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 5 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 1 Oct 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?
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?
repeated measures ANOVA (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06618690, which also lists 4 linked publications.
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 1 Oct 2024; AzTrials last refreshed its copy on 2 Nov 2026.