Telerehabilitation Program Via Videoconference PAH - Randomized Clinical Trial

Sponsor

University of Nove de Julho (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05655481

Collaborator

(none)

Enrollment

Location

Arms

27.8

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension Cardiovascular Diseases Respiratory Disease Nursing Hypertension, Pulmonary Pulmonary Hypertension	Other: Aerobic and Resistance training with rehabilitation Other: Health education	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 15, 2023

Anticipated Primary Completion Date :

Apr 25, 2023

Anticipated Study Completion Date :

May 10, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telerehabilitation AEROBIC TRAINING 2 training sessions per week for a period of 8 weeks Connection platform: WhatsApp The research participant will use a 20 cm step on which he will have to go up and down until he reaches the predicted training heart rate. Intensity: 60-80% of the maximum heart rate reached at the peak of the incremental step test 5 minutes warm-up: 60% of maximum heart rate 20 minutes of Training: 60 to 80% of the maximum heart rate reached at the peak of the incremental step test 5 minute cool down: 60% of maximum heart rate Duration 30 minutes RESISTANCE TRAINING Devices: Anklet (variable load), these devices will be made available to the research participant Exercises for upper limbs, shoulder flexion, elbow flexion and shoulder abduction, and for lower limbs hip flexion and extension. Intensity: 70% of the maximum starting load of a 1RM repetition 3 sets of 8 repetitions Duration: 30 minutes	Other: Aerobic and Resistance training with rehabilitation Effects of home telerehabilitation program improve functional capacity variables
Experimental: Telehealth Guidelines leaflet with health education proposals Explanations about your disease, what it is, psychopathological diagnoses and pharmacological and non-pharmacological treatment), information about the importance of physical activity in your daily life, such as walking, stretching or some daily physical activity according to your preference . This group will not receive aerobic or resistance training. You will receive telemonitoring twice a week over a period of 8 weeks as a form of teleconsultation in health with the physiotherapist for monitoring throughout the research. After this period it will be reassessed.	Other: Health education Telehealth and guidelines for the practice of physical activity and health education

Arm

Intervention/Treatment

Experimental: Telerehabilitation

AEROBIC TRAINING 2 training sessions per week for a period of 8 weeks Connection platform: WhatsApp The research participant will use a 20 cm step on which he will have to go up and down until he reaches the predicted training heart rate. Intensity: 60-80% of the maximum heart rate reached at the peak of the incremental step test 5 minutes warm-up: 60% of maximum heart rate 20 minutes of Training: 60 to 80% of the maximum heart rate reached at the peak of the incremental step test 5 minute cool down: 60% of maximum heart rate Duration 30 minutes RESISTANCE TRAINING Devices: Anklet (variable load), these devices will be made available to the research participant Exercises for upper limbs, shoulder flexion, elbow flexion and shoulder abduction, and for lower limbs hip flexion and extension. Intensity: 70% of the maximum starting load of a 1RM repetition 3 sets of 8 repetitions Duration: 30 minutes

Other: Aerobic and Resistance training with rehabilitation

Effects of home telerehabilitation program improve functional capacity variables

Experimental: Telehealth

Guidelines leaflet with health education proposals Explanations about your disease, what it is, psychopathological diagnoses and pharmacological and non-pharmacological treatment), information about the importance of physical activity in your daily life, such as walking, stretching or some daily physical activity according to your preference . This group will not receive aerobic or resistance training. You will receive telemonitoring twice a week over a period of 8 weeks as a form of teleconsultation in health with the physiotherapist for monitoring throughout the research. After this period it will be reassessed.

Other: Health education

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

Outcome Measures

Primary Outcome Measures

Functional exercise capacity [Change from baseline to 8 weeks]
Oxygen consumption measured during cardiopulmonary testing
6 Minute Walking Test [Change from baseline to 8 weeks]
Distance in meters
Maximum heart rate [Change from baseline to 8 weeks]
Correlate the maximum heart rate of both functional capacity tests
Interchangeable tests [Change from baseline to 8 weeks]
Correlate the distance covered in the six-minute walk test with the number of climbs in the incremental step test

Secondary Outcome Measures

FVC [Change from baseline to 8 weeks]
Lung function - forced vital capacity
FEV1 [Change from baseline to 8 weeks]
Lung function - expiratory volume in 1 second
Health-related quality of life score [Change from baseline to 8 weeks]
scores by EmPHasis-10- health-related quality of life Pulmonary hypertension. Score 0-50

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.