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

NCT06618690 | Active Not Recruiting DMC

• 1 other identifier: IO/2024
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Female Breast Cancer

Keywords

breast cancer; exercise; quality of life; muscle strength

Outcome Measures

Primary Outcomes (1)

• repeated measures ANOVA

  the range of motion, tone and muscle strength of the group will be measured in 3 measures over the 12 weeks

  12 weeks

Study Arms (2)

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.

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.

Interventions

Exercise program 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.

Grupo experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Burgos: lead

Study Sites (1)

Hospital Universitario Torrecárdenas

Àlmeria, Alemeria, Spain

Location

Related Publications (4)

• 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.

  PMID: 33475878 BACKGROUND

• 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.

  PMID: 37656241 BACKGROUND

• 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.

  PMID: 38061307 BACKGROUND

• 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.

  PMID: 40073395 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: October 1, 2024
• Study Start: September 10, 2024
• Primary Completion: February 1, 2025
• Study Completion: April 2, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)