Exercise Program on Pain, Physical Function, and Quality of Life in Breast Cancer Survivors (IO/2024)

September 27, 2024 updated by: Universidad de Burgos

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

325

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alemeria
      • Àlmeria, Alemeria, Spain
        • Hospital Universitario Torrecárdenas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Burgos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

April 2, 2025

Study Registration Dates

First Submitted

September 16, 2024

First Submitted That Met QC Criteria

September 27, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 27, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IO/2024 (Other Identifier: Universidad de Burgos)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Female Breast Cancer

Clinical Trials on Exercise program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe