Clinical trial NCT06547853: Physical and Health Outcomes With ExeRcise in Cancer SURVIVORS
Official title: Effect of an Exercise Program on Physical Performance and Health Outcomes in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Exercise
Keywords: Cancer Survivors
Breast Cancer
Physical Exercise
Lead sponsor: Federal University of Alagoas
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Exercise adherence
timeFrame: 12-weeks intervention
Secondary outcomes:
measure: Change in systolic and diastolic blood pressure
timeFrame: 12-weeks
measure: Change in cardiorespiratory fitness
timeFrame: 12-weeks
measure: Change in depression total score
timeFrame: 12-weeks
measure: Change in pain total score
timeFrame: 12-weeks
measure: Change in Health-related Quality of Life total score
timeFrame: 12-weeks
measure: Change in Sleep quality
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Alagoas
country: Brazil
facility: Federal University of Alagoas Institute of Physical Education and Sports
state: Maceio
Study officials:
affiliation: Federal University of Alagoas Institute of Physical Education and Sports
name: Jean Toscano, PhD
role: PRINCIPAL_INVESTIGATOR
References: