Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05655481
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-12-21
First Post:
2022-12-08
Brief Title:
Telerehabilitation Program Via Videoconference PAH - Randomized Clinical Trial
Sponsor:
University of Nove de Julho
Organization:
University of Nove de Julho
Study Overview
Official Title:
Effects of a Home Telerehabilitation Program Via Videoconference in Patients With Pulmonary Arterial Hypertension- Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 theres 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 9661m after 15 weeks compared to the control group p0001 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 variationsor increase in the sympathetic impulse
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 theres 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 9661m after 15 weeks compared to the control group p0001 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 variationsor increase in the sympathetic impulse
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None