Physical and Health Outcomes With ExeRcise in Cancer SURVIVORS

Not Applicable

Recruiting

• Conditions: Breast Cancer Female; Exercise
• Interventions: Behavioral: Physical exercise

• Registration Number: NCT06547853
• Lead Sponsor: Federal University of Alagoas

Brief Summary

This study aims to evaluate the effect of a physical exercise intervention model on breast cancer survivors and their adherence. The sample will consist of 30 women with a primary diagnosis of breast cancer. The intervention will be carried out in a highly complex oncology center in Maceió-AL, Brazil, using the FITT components of the prescription: frequency (4 days a week), intensity (aerobic part through musical beats, subjective perception scale and resistance exercises through the number of maximum repetitions), the total time of each session will be 45 minutes. The intervention arms include combined exercise training and aerobic exercise (i.e., walking). Adherence to each intervention evaluated in the 12-week intervention cycle will be measured in each session.

Detailed Description

The study participants will be enrolled in a visit to a group of psychologic therapy women cancer survivors who met monthly and who have submitted to breast cancer treatment in a hospital in the city of Maceió (AL), Brazil, classified as High Complexity Oncologic Clinic. At this visit, the proposal for physical exercises will be presented in the hospital area. Volunteers will be scheduled for an in-person visit and assessed for eligibility. Those who meet all the inclusion/exclusion criteria will be invited to integrate the physical exercise intervention.

The 12-week exercise intervention will consist of a combined exercise including an aerobic component (dance) and resistance training, and aerobic exercise (i.e., walking). Participants will be evaluated pre- and post-intervention in terms of several health indicators. All ethical approvals were collected before study initiation.

Study Timeline

• Study Start: 2024-07-01
• Study First Submitted: 2024-07-21
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-08
• Last Update Submitted: 2024-08-08
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Primary Completion: 2024-09-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Women;
2. Adults;
3. confirmed diagnostic of breast cancer and with treatment completed (surgery, radiotherapy, or chemotherapy) within the previous six months.

Exclusion Criteria

1. present metastatic breast cancer;
2. any clinical condition that would make participating in the exercise intervention impossible.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combined exercise training	Physical exercise	In the combined exercise training regimen, participants will perform two hospital-based sessions with 45 minutes of aerobic dance and resistance training. The intensity of the aerobic dance will be \~ 132-135 beats per minute, whereas the intensity of the resistance training will be measured by the subjective rate of perceived exertion. The resistance exercise training regimen was set in a circuit, and participants will perform six exercises per session targeting the large muscle groups. Each exercise will be executed in two sets per session.

Primary Outcome Measures

Name	Time	Method
Exercise adherence	12-weeks intervention	Total adherence will be expressed by the percentage of attendance by each participant in the total exercise intervention length. This will be measured by the study staff as the participants presence in each session.

Secondary Outcome Measures

Name	Time	Method
Change in systolic and diastolic blood pressure	12-weeks	Blood pressure is going to be measured after 10 minutes in a seated position. Mean Systolic blood pressure and diastolic blood pressure will be evaluated through a digital wrist monitor.
Change in cardiorespiratory fitness	12-weeks	cardiorespiratory fitness will be evaluated through the 6-minutes walk test
Change in pain total score	12-weeks	Pain will be evaluated using the Brief Pain Inventory (BPI) total score
Change in Sleep quality	12-weeks	Sleep quality will be evaluated using the The Pittsburgh Sleep Quality Index (PSQI)
Change in Health-related Quality of Life total score	12-weeks	Health-related quality of life will be evaluated through the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)
Change in depression total score	12-weeks	Depression will be evaluated using the 9-Item Patient Health Questionnaire (PHQ-9) total score

Trial Locations

Locations (1)

Federal University of Alagoas Institute of Physical Education and Sports; 🇧🇷 Alagoas, Maceio, Brazil