Physical and Health Outcomes With ExeRcise in Cancer SURVIVORS

NCT06547853 | Recruiting

• 1 other identifier: CAAE - 54130721.3.0000.5013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female; Exercise

Keywords

Cancer Survivors; Breast Cancer; Physical Exercise

Outcome Measures

Primary Outcomes (1)

• Exercise adherence

  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.

  12-weeks intervention

Secondary Outcomes (6)

• Change in systolic and diastolic blood pressure

  12-weeks

• Change in cardiorespiratory fitness

  12-weeks

• Change in depression total score

  12-weeks

• Change in pain total score

  12-weeks

• Change in Health-related Quality of Life total score

  12-weeks

Study Arms (1)

Combined exercise training

EXPERIMENTAL

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.

Behavioral: Physical exercise

Interventions

Physical exercise 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).

Combined exercise training

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Alagoas: lead

Study Sites (1)

Federal University of Alagoas Institute of Physical Education and Sports

Alagoas, Maceio, Brazil

RECRUITING

MeSH Terms

Conditions

Motor Activity; Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jean Toscano, PhD

  Federal University of Alagoas Institute of Physical Education and Sports

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Toscano, PhD

CONTACT

+55 82988311415; jean.toscano@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: August 9, 2024
• Study Start: July 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: July 31, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

BR (1)