Physical and Health Outcomes With ExeRcise in Cancer SURVIVORS (POWERSurviv)

August 8, 2024 updated by: Federal University of Alagoas

Effect of an Exercise Program on Physical Performance and Health Outcomes in Cancer Survivors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

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 Contact

Study Locations

  • Brazil
    • Maceio
      • Alagoas, Maceio, Brazil
        • Recruiting
        • Federal University of Alagoas Institute of Physical Education and Sports
        • Contact:
        • Principal Investigator:
          • Jean Toscano, PhD

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:

  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 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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise adherence
Time Frame: 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.
12-weeks intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in systolic and diastolic blood pressure
Time Frame: 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.
12-weeks
Change in cardiorespiratory fitness
Time Frame: 12-weeks
cardiorespiratory fitness will be evaluated through the 6-minutes walk test
12-weeks
Change in depression total score
Time Frame: 12-weeks
Depression will be evaluated using the 9-Item Patient Health Questionnaire (PHQ-9) total score
12-weeks
Change in pain total score
Time Frame: 12-weeks
Pain will be evaluated using the Brief Pain Inventory (BPI) total score
12-weeks
Change in Health-related Quality of Life total score
Time Frame: 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)
12-weeks
Change in Sleep quality
Time Frame: 12-weeks
Sleep quality will be evaluated using the The Pittsburgh Sleep Quality Index (PSQI)
12-weeks

Collaborators and Investigators

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

Sponsor

Federal University of Alagoas

Investigators

  • Principal Investigator: Jean Toscano, PhD, Federal University of Alagoas Institute of Physical Education and Sports

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)

July 1, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

July 21, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE - 54130721.3.0000.5013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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