Breast Cancer FemalePOWERSurvivNCT06547853
Physical and Health Outcomes With ExeRcise in Cancer SURVIVORS
A study testing Physical exercise in people with Breast Cancer Female and Exercise, run by Federal University of Alagoas at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer Female, Exercise
- What is being tested?
- Physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women;
- Adults;
- confirmed diagnostic of breast cancer and with treatment completed (surgery, radiotherapy, or chemotherapy) within the previous six months.
Who cannot join
- present metastatic breast cancer;
- any clinical condition that would make participating in the exercise intervention impossible.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Alagoas Institute of Physical Education and Sports
Alagoas, Maceio
Jean Toscano, PhD, +55 82988311415, jean.toscano@hotmail.com
Jean Toscano, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer Female, Exercise
- Being tested
- Physical exercise
- Keywords
- Cancer Survivors, Breast Cancer, Physical Exercise
- Medical subject headings
- Motor Activity, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Combined exercise training | Experimental | 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. Receives: Behavioral: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise adherence
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.
Measured: 12-weeks intervention
Secondary outcomes (6)
Change in systolic and diastolic blood pressure
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.
Measured: 12-weeks
Change in cardiorespiratory fitness
cardiorespiratory fitness will be evaluated through the 6-minutes walk test
Measured: 12-weeks
Change in depression total score
Depression will be evaluated using the 9-Item Patient Health Questionnaire (PHQ-9) total score
Measured: 12-weeks
Change in pain total score
Pain will be evaluated using the Brief Pain Inventory (BPI) total score
Measured: 12-weeks
Change in Health-related Quality of Life total score
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)
Measured: 12-weeks
Change in Sleep quality
Sleep quality will be evaluated using the The Pittsburgh Sleep Quality Index (PSQI)
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Jul 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Alagoas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Toscano, PhD, Principal investigator, Federal University of Alagoas Institute of Physical Education and Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547853
- Sponsor's protocol ID
- CAAE - 54130721.3.0000.5013
- Acronym
- POWERSurviv
- Status last verified
- Aug 2024
- First submitted
- 21 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Exercise Program on Physical Performance and Health Outcomes in Cancer Survivors
- ClinicalTrials.gov ID
- NCT06547853
- Acronym / sponsor ID
- POWERSurviv / CAAE - 54130721.3.0000.5013
- Conditions
- Breast Cancer Female, Exercise
- Keywords
- Cancer Survivors, Breast Cancer, Physical Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of AlagoasUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined exercise training | Experimental | Behavioral: Physical exerciseIn 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women;
- Adults;
- confirmed diagnostic of breast cancer and with treatment completed (surgery, radiotherapy, or chemotherapy) within the previous six months.
Key exclusion criteria (2 listed)
- present metastatic breast cancer;
- any clinical condition that would make participating in the exercise intervention impossible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exerciseGroups 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). | Behavioural | Combined exercise training |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Toscano, PhD principal investigator
Federal University of Alagoas Institute of Physical Education and Sports
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise in people with Breast Cancer Female and Exercise, run by Federal University of Alagoas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Toscano, PhD (+55 82988311415, jean.toscano@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise adherence (time frame: 12-weeks intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.