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Telerehabilitation Program Via Videoconference PAH - Randomized Clinical Trial

Effects of a Home Telerehabilitation Program Via Videoconference in Patients With Pulmonary Arterial Hypertension- Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05655481
Enrollment
50
Registered
2022-12-19
Start date
2023-01-15
Completion date
2025-05-10
Last updated
2022-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Hypertension, Pulmonary, Pulmonary Arterial Hypertension, Pulmonary Hypertension, Respiratory Disease Nursing

Keywords

Exercise Functional Capacity, Pulmonary Arterial Hypertension, Telerehabilitation, Functional Capacity

Brief summary

Pulmonary arterial hypertension (PAH) is a serious, progressive disease that causes pulmonary arterial pressure, significantly affecting functional capacity and quality of life. Over the last few years, knowledge in pulmonary hypertension has evolved consistently and significantly. New diagnostic and treatment algorithms were combined based on the results of several clinical studies that showed the usefulness of new tools, as well as the effectiveness of new drugs as well as non-pharmacological treatment. The new guidelines felt the benefits of physical exercise in individuals with PAH, with promising results in improving symptoms, exercise capacity, peripheral muscle function and quality of life. With the COVID 19 pandemic, the complex scenario was for world health, and social distancing made it impossible to carry out individual outpatient rehabilitation, in groups and in person, indicating the need for rehabilitation programs, including physical training, to be adapted to the domicile. New alternative modes of pulmonary rehabilitation include home-based models and the use of telehealth. Telerehabilitation is the provision of rehabilitation services at a distance, using information and communication technologies. To date, there has been no evaluation of the clinical efficacy or safety of telerehabilitation in the population affected by PAH.

Detailed description

Pulmonary arterial hypertension is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. In one form of pulmonary hypertension, called PAH, blood vessels in the lungs are narrowed, blocked or destroyed. The damage slows blood flow through the lungs, and blood pressure in the lung arteries rises. The heart must work harder to pump blood through the lungs. The extra effort eventually causes the heart muscle to become weak and fail. In some people, pulmonary hypertension slowly gets worse and can be life-threatening. Although there's no cure for some types of pulmonary hypertension, treatment can help reduce symptoms and improve quality of life. Several studies show the importance of physical training in patients with PAH. In the study by Meirelles et al. individuals with severe chronic PAH achieved positive results when manifested to physical training, improved the distance walked in the 6-minute walk test (6MWD) by 96±61m after 15 weeks compared to the control group (p\<0.001) and several other studies point out the importance of aerobic training for this pulmonary hypertension (PH) population. However, it is known that exercise limitation in PAH is multifactorial, having right ventricular dysfunction, chronotropic incompetence, ventilatory abnormalities and skeletal muscle dysfunction as causes. mechanical restrictions, poor oxygenation of the skeletal and cerebral muscle, hyperventilation with variations/or increase in the sympathetic impulse.

Interventions

OTHERAerobic and Resistance training with rehabilitation

Effects of home telerehabilitation program improve functional capacity variables

OTHERHealth education

Telehealth and guidelines for the practice of physical activity and health education

Sponsors

University of Nove de Julho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Participants with PAH from group 1 of the HP leaderboard * Confirmed diagnosis of PAH by cardiac catheterization measurements as defined in group 1, with NHNY functional class I to IV (receiving specific pharmacological therapy for PAH), aged 18 to 70 years * They are clinically stable without having been hospitalized in the last few weeks. * Having internet with a data package and knowing how to use WhatsApp to manage telerehabilitation

Exclusion criteria

* Requiring continuous oxygen therapy * Clinical groups 3, 4 and 5 * Significant musculoskeletal disease or limb claudication pain; Psychological or cognitive impairment, psychiatric psychological or mood disorders that may affect your ability to perform the clinical field test * History of moderate or severe chronic lung disease * Left heart disease, angina and/or fast heart rate.

Design outcomes

Primary

MeasureTime frameDescription
Functional exercise capacityChange from baseline to 8 weeksOxygen consumption measured during cardiopulmonary testing
6 Minute Walking TestChange from baseline to 8 weeksDistance in meters
Maximum heart rateChange from baseline to 8 weeksCorrelate the maximum heart rate of both functional capacity tests
Interchangeable testsChange from baseline to 8 weeksCorrelate the distance covered in the six-minute walk test with the number of climbs in the incremental step test

Secondary

MeasureTime frameDescription
FEV1Change from baseline to 8 weeksLung function - expiratory volume in 1 second
Health-related quality of life scoreChange from baseline to 8 weeksscores by EmPHasis-10- health-related quality of life Pulmonary hypertension. Score 0-50
FVCChange from baseline to 8 weeksLung function - forced vital capacity

Countries

Brazil

Contacts

Primary ContactLuciana Malosa Sampaio, Ph.D
lucianamalosa@gmail.com+5511996002075
Backup ContactJonathan Luiz da Silva, M.Sc
jhonathanluys42@gmail.com+5511912549818

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026