NCT06618690

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

Efficacy of a Supervised Exercise Program on Pain, Physical Function, and Quality of Life in Breast Cancer Survivors: Protocol for a Randomized Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 325 (estimated)
• Sponsor: Universidad de Burgos · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2024-09-10
• Primary completion: 2025-02-01
• Completion: 2025-04-02
• First posted: 2024-10-01
• Last updated: 2024-10-01

Locations

1 site across 1 country: Spain