Physical and Health Outcomes With ExeRcise in Cancer SURVIVORS

NCT ID: NCT06547853

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-07-31

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.

Conditions

Breast Cancer Female; Exercise

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined exercise training

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.

Group Type: EXPERIMENTAL

Physical exercise

Intervention Type: BEHAVIORAL

Groups will be enrolled in a 12-week exercise program. The intervention will be carried out in a highly complex oncology center in Maceió-AL, 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 a number of maximum repetitions), the time of each session will be 45 minutes, the type of activity offered will be combined exercise training and aerobic exercise training (i.e., walking).

Interventions

Physical exercise

Groups will be enrolled in a 12-week exercise program. The intervention will be carried out in a highly complex oncology center in Maceió-AL, 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 a number of maximum repetitions), the time of each session will be 45 minutes, the type of activity offered will be combined exercise training and aerobic exercise training (i.e., walking).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Alagoas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Toscano, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Alagoas Institute of Physical Education and Sports

Locations

Federal University of Alagoas Institute of Physical Education and Sports

Alagoas, Maceio, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Jean Toscano, PhD

Role: CONTACT

jean.toscano@hotmail.com

+55 82988311415

Facility Contacts

Jean Toscano, PhD

Role: primary

jean.toscano@hotmail.com

+55 82988311415

Other Identifiers

CAAE - 54130721.3.0000.5013

Identifier Type: -

Identifier Source: org_study_id