Physical and Health Outcomes With ExeRcise in Cancer SURVIVORS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical exercise.
- Who it may be relevant to
- Registry conditions: Breast Cancer Female, Exercise. Basic parameters: 18 years — 90 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of an Exercise Program on Physical Performance and Health Outcomes in Cancer Survivors
Overview
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.
Interventions
- 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.
Primary outcome measures
- Exercise adherence [Time frame: 12-weeks intervention]
Secondary outcome measures (6)
- Change in systolic and diastolic blood pressure [Time frame: 12-weeks]
- Change in cardiorespiratory fitness [Time frame: 12-weeks]
- Change in depression total score [Time frame: 12-weeks]
- Change in pain total score [Time frame: 12-weeks]
- Change in Health-related Quality of Life total score [Time frame: 12-weeks]
- Change in Sleep quality [Time frame: 12-weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Federal University of Alagoas Institute of Physical Education and Sports — Alagoas
Identifiers
NCT: NCT06547853 · CAAE - 54130721.3.0000.5013