Physical and Health Outcomes With ExeRcise in Cancer SURVIVORS

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Exercise adherence [Срок оценки: 12-weeks intervention]

Вторичные конечные точки (6)

• Change in systolic and diastolic blood pressure [Срок оценки: 12-weeks]
• Change in cardiorespiratory fitness [Срок оценки: 12-weeks]
• Change in depression total score [Срок оценки: 12-weeks]
• Change in pain total score [Срок оценки: 12-weeks]
• Change in Health-related Quality of Life total score [Срок оценки: 12-weeks]
• Change in Sleep quality [Срок оценки: 12-weeks]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Federal University of Alagoas Institute of Physical Education and Sports — Alagoas

Идентификаторы

NCT: NCT06547853 · CAAE - 54130721.3.0000.5013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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