Clinical trial NCT05655481: Telerehabilitation Program Via Videoconference PAH - Randomized Clinical Trial
Official title: Effects of a Home Telerehabilitation Program Via Videoconference in Patients With Pulmonary Arterial Hypertension- Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Cardiovascular Diseases
Respiratory Disease Nursing
Hypertension, Pulmonary
Pulmonary Hypertension
Keywords: Exercise Functional Capacity
Pulmonary Arterial Hypertension
Telerehabilitation
Functional Capacity
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional exercise capacity
timeFrame: Change from baseline to 8 weeks
measure: 6 Minute Walking Test
timeFrame: Change from baseline to 8 weeks
measure: Maximum heart rate
timeFrame: Change from baseline to 8 weeks
measure: Interchangeable tests
timeFrame: Change from baseline to 8 weeks
Secondary outcomes:
measure: FVC
timeFrame: Change from baseline to 8 weeks
measure: FEV1
timeFrame: Change from baseline to 8 weeks
measure: Health-related quality of life score
timeFrame: Change from baseline to 8 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Luciana Maria Malosa Sampaio
state: Sao Paulo
Study officials:
affiliation: University of Nove de Julho
name: Luciana Malosa Sampaio, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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