Exercise Program on Pain, Physical Function, and Quality of Life in Breast Cancer Survivors

NCT ID: NCT06618690

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-10

Study Completion Date

2025-04-02

Brief Summary

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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

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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

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Female Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Grupo 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.

Group Type EXPERIMENTAL

Exercise program

Intervention Type OTHER

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.

group control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise program

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* not attending scheduled sessions to instruct on the exercises to be performed, - being part of other studies,
* undergoing another type of therapy
* pregnancy patients.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Burgos

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario Torrecárdenas

Àlmeria, Alemeria, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 33475878 (View on PubMed)

Michels 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.

Reference Type BACKGROUND
PMID: 37656241 (View on PubMed)

Tuchler 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.

Reference Type BACKGROUND
PMID: 38061307 (View on PubMed)

Garcia-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.

Reference Type DERIVED
PMID: 40073395 (View on PubMed)

Other Identifiers

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IO/2024

Identifier Type: OTHER

Identifier Source: secondary_id

IO/2024

Identifier Type: -

Identifier Source: org_study_id

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