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NCT Number: NCT06547853

Physical and Health Outcomes With ExeRcise 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.

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Key information

Conditions

Breast Cancer Female Behavior Breast Diseases Breast Neoplasms Exercise Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Alagoas Institute of Physical Education and Sports

Alagoas, Maceio, Brazil

Location status: Recruiting

Location contact

Jean Toscano, PhD

CONTACT

[email protected]

+55 82988311415

Jean Toscano, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Change in cardiorespiratory fitness

    Time frame: 12-weeks

    cardiorespiratory fitness will be evaluated through the 6-minutes walk test

  3. Change in depression total score

    Time frame: 12-weeks

    Depression will be evaluated using the 9-Item Patient Health Questionnaire (PHQ-9) total score

  4. Change in pain total score

    Time frame: 12-weeks

    Pain will be evaluated using the Brief Pain Inventory (BPI) total score

  5. 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)

  6. Change in Sleep quality

    Time frame: 12-weeks

    Sleep quality will be evaluated using the The Pittsburgh Sleep Quality Index (PSQI)

Study contacts

Contact information is provided by the study sponsor or research team.

Jean Toscano, PhD

CONTACT

[email protected]

+55 82988311415

Sponsors and collaborators

Lead sponsor

Federal University of Alagoas

Other

Registry information

Official study title

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

Acronym: POWERSurviv

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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