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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Female Breast Cancer Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Torrecárdenas

Àlmeria, Alemeria, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Universidad de Burgos

Other

Registry information

Official study 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

Acronym: IO/2024

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 1, 2024
Registry last updated: Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed