ArrhythmiaPAL-PACNCT07132853
Assessment of Physical Activity Levels in Patients With Cardiac Arrhythmias
An observational study of Arrhythmia and Physical Activity, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Physical activity is defined as any bodily movement that results in energy expenditure. Athletes are individuals who engage in planned, structured physical exercise under guidance, with specific goals and competitive objectives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia, Physical Activity
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Nov 2021to 22 Aug 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: A convenience sample of 100 consecutive patients followed at the arrhythmia outpatient clinic of InCor - HCFMUSP.
Who may be able to join
- Individuals with a documented diagnosis of arrhythmia who are followed at the arrhythmia outpatient clinic of InCor.
- Signed informed consent form or assent form.
Who cannot join
- Bedridden patients or those with mobility impairments.
- Patients with advanced-stage diseases (estimated life expectancy of less than one year).
- Patients participating in other studies.
Trial locations and contacts
1 site in 1 country.
About this study
Physical activity is defined as any bodily movement that results in energy expenditure. Athletes are individuals who engage in planned, structured physical exercise under guidance, with specific goals and competitive objectives. For this population, pre-participation cardiovascular screening is well established, aiming to identify cardiac conditions that may lead to sudden death and/or cardiovascular events. However, athletes represent a minority of patients attending cardiac arrhythmia outpatient clinics. Most patients are either sedentary or engage in-or wish to engage in-some form of physical activity, but are often discouraged for various reasons, leading to increased physical inactivity. This occurs despite the well-documented benefits of physical activity across all age groups and various forms of heart disease, including improved quality of life, reduced depression and anxiety, and enhanced overall well-being. Despite existing recommendations, the prevalence of physically active individuals among patients followed at the Arrhythmia Outpatient Clinic of the Heart Institute (InCor) of the Hospital das Clínicas, University of São Paulo, remains unknown. Understanding these factors through such mapping may contribute to improved clinical management and potentially enhance the quality of life of patients with cardiac arrhythmias.
- Conditions
- Arrhythmia, Physical Activity
- Keywords
- arrythmia, physical activity
- Medical subject headings
- Arrhythmias, Cardiac, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arrhythmia | Physical activity level description |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-12 Health Survey
Quality of life was assessed using SF-12's Physical and Mental scores.
Measured: Baseline
Secondary outcomes (1)
International Physical Activity Questionnaire (IPAQ)
Describe the physical activity level by IPAQ
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start25 Nov 2021
- Primary completion15 Aug 2023
- Study completion22 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savia Christina Pereira Bueno, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132853
- Sponsor's protocol ID
- 5.127.777
- Acronym
- PAL-PAC
- Status last verified
- Sep 2025
- First submitted
- 5 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Physical Activity Levels in Patients With Cardiac Arrhythmias
- ClinicalTrials.gov ID
- NCT07132853
- Acronym / sponsor ID
- PAL-PAC / 5.127.777
- Conditions
- Arrhythmia, Physical Activity
- Keywords
- arrythmia, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 22 Aug 2023 (actual)
- First posted
- 20 Aug 2025 (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.
Physical activity is defined as any bodily movement that results in energy expenditure. Athletes are individuals who engage in planned, structured physical exercise under guidance, with specific goals and competitive objectives. For this population, pre-participation cardiovascular screening is well established, aiming to identify cardiac conditions that may lead to sudden death and/or cardiovascular events. However, athletes represent a minority of patients attending cardiac arrhythmia outpatient clinics. Most patients are either sedentary or engage in-or wish to engage in-some form of physical activity, but are often discouraged for various reasons, leading to increased physical inactivity. This occurs despite the well-documented benefits of physical activity across all age groups and various forms of heart disease, including improved quality of life, reduced depression and anxiety, and enhanced overall well-being. Despite existing recommendations, the prevalence of physically active individuals among patients followed at the Arrhythmia Outpatient Clinic of the Heart Institute (InCor) of the Hospital das Clínicas, University of São Paulo, remains unknown. Understanding these factors through such mapping may contribute to improved clinical management and potentially enhance the quality of life of patients with cardiac arrhythmias.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arrhythmia | – | –Physical activity level description |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A convenience sample of 100 consecutive patients followed at the arrhythmia outpatient clinic of InCor - HCFMUSP.
Key inclusion criteria (2 listed)
- Individuals with a documented diagnosis of arrhythmia who are followed at the arrhythmia outpatient clinic of InCor.
- Signed informed consent form or assent form.
Key exclusion criteria (3 listed)
- Bedridden patients or those with mobility impairments.
- Patients with advanced-stage diseases (estimated life expectancy of less than one year).
- Patients participating in other studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SF-12 Health Survey
Time frame: Baseline
Quality of life was assessed using SF-12's Physical and Mental scores.
1 secondary outcome
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
Related trials for Arrhythmia
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia and Physical Activity, run by University of Sao Paulo 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 15 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-12 Health Survey (time frame: Baseline). 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 15 Sep 2025.