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Telerehabilitation Program Via Videoconference PAH - Randomized Clinical Trial

Primary Purpose

Pulmonary Arterial Hypertension, Cardiovascular Diseases, Respiratory Disease Nursing

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aerobic and Resistance training with rehabilitation
Health education
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Exercise Functional Capacity, Pulmonary Arterial Hypertension, Telerehabilitation, Functional Capacity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Luciana Maria Malosa Sampaio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Telerehabilitation

Telehealth

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

FVC
Lung function - forced vital capacity
FEV1
Lung function - expiratory volume in 1 second
Health-related quality of life score
scores by EmPHasis-10- health-related quality of life Pulmonary hypertension. Score 0-50

Full Information

First Posted
December 8, 2022
Last Updated
December 16, 2022
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT05655481
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2023 (Anticipated)
Primary Completion Date
April 25, 2023 (Anticipated)
Study Completion Date
May 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension, Cardiovascular Diseases, Respiratory Disease Nursing, Hypertension, Pulmonary, Pulmonary Hypertension
Keywords
Exercise Functional Capacity, Pulmonary Arterial Hypertension, Telerehabilitation, Functional Capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation
Arm Type
Experimental
Arm Description
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
Arm Title
Telehealth
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic and Resistance training with rehabilitation
Intervention Description
Effects of home telerehabilitation program improve functional capacity variables
Intervention Type
Other
Intervention Name(s)
Health education
Intervention Description
Telehealth and guidelines for the practice of physical activity and health education
Primary Outcome Measure Information:
Title
Functional exercise capacity
Description
Oxygen consumption measured during cardiopulmonary testing
Time Frame
Change from baseline to 8 weeks
Title
6 Minute Walking Test
Description
Distance in meters
Time Frame
Change from baseline to 8 weeks
Title
Maximum heart rate
Description
Correlate the maximum heart rate of both functional capacity tests
Time Frame
Change from baseline to 8 weeks
Title
Interchangeable tests
Description
Correlate the distance covered in the six-minute walk test with the number of climbs in the incremental step test
Time Frame
Change from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
FVC
Description
Lung function - forced vital capacity
Time Frame
Change from baseline to 8 weeks
Title
FEV1
Description
Lung function - expiratory volume in 1 second
Time Frame
Change from baseline to 8 weeks
Title
Health-related quality of life score
Description
scores by EmPHasis-10- health-related quality of life Pulmonary hypertension. Score 0-50
Time Frame
Change from baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luciana Malosa Sampaio, Ph.D
Phone
+5511996002075
Email
lucianamalosa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Luiz da Silva, M.Sc
Phone
+5511912549818
Email
jhonathanluys42@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciana Malosa Sampaio, Ph.D
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luciana Maria Malosa Sampaio
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
03332010
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luciana Malosa Sampaio, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26185169
Citation
Pandey A, Garg S, Khunger M, Garg S, Kumbhani DJ, Chin KM, Berry JD. Efficacy and Safety of Exercise Training in Chronic Pulmonary Hypertension: Systematic Review and Meta-Analysis. Circ Heart Fail. 2015 Nov;8(6):1032-43. doi: 10.1161/CIRCHEARTFAILURE.115.002130. Epub 2015 Jul 16. Erratum In: Circ Heart Fail. 2015 Nov;8(6):1143.
Results Reference
result
PubMed Identifier
25896259
Citation
Buys R, Avila A, Cornelissen VA. Exercise training improves physical fitness in patients with pulmonary arterial hypertension: a systematic review and meta-analysis of controlled trials. BMC Pulm Med. 2015 Apr 22;15:40. doi: 10.1186/s12890-015-0031-1.
Results Reference
result
PubMed Identifier
26231884
Citation
Ehlken N, Lichtblau M, Klose H, Weidenhammer J, Fischer C, Nechwatal R, Uiker S, Halank M, Olsson K, Seeger W, Gall H, Rosenkranz S, Wilkens H, Mertens D, Seyfarth HJ, Opitz C, Ulrich S, Egenlauf B, Grunig E. Exercise training improves peak oxygen consumption and haemodynamics in patients with severe pulmonary arterial hypertension and inoperable chronic thrombo-embolic pulmonary hypertension: a prospective, randomized, controlled trial. Eur Heart J. 2016 Jan 1;37(1):35-44. doi: 10.1093/eurheartj/ehv337. Epub 2015 Jul 31.
Results Reference
result
PubMed Identifier
16982941
Citation
Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, Holzapfel N, Opitz C, Winkler J, Herth FF, Wilkens H, Katus HA, Olschewski H, Grunig E. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation. 2006 Oct 3;114(14):1482-9. doi: 10.1161/CIRCULATIONAHA.106.618397. Epub 2006 Sep 18.
Results Reference
result
PubMed Identifier
21694556
Citation
Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
Results Reference
result
PubMed Identifier
25269680
Citation
Pradella CO, Belmonte GM, Maia MN, Delgado CS, Luise AP, Nascimento OA, Gazzotti MR, Jardim JR. Home-Based Pulmonary Rehabilitation for Subjects With COPD: A Randomized Study. Respir Care. 2015 Apr;60(4):526-32. doi: 10.4187/respcare.02994. Epub 2014 Sep 30.
Results Reference
result
PubMed Identifier
26873944
Citation
Maron BA, Hess E, Maddox TM, Opotowsky AR, Tedford RJ, Lahm T, Joynt KE, Kass DJ, Stephens T, Stanislawski MA, Swenson ER, Goldstein RH, Leopold JA, Zamanian RT, Elwing JM, Plomondon ME, Grunwald GK, Baron AE, Rumsfeld JS, Choudhary G. Association of Borderline Pulmonary Hypertension With Mortality and Hospitalization in a Large Patient Cohort: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program. Circulation. 2016 Mar 29;133(13):1240-8. doi: 10.1161/CIRCULATIONAHA.115.020207. Epub 2016 Feb 12.
Results Reference
result
PubMed Identifier
18277824
Citation
Desai SA, Channick RN. Exercise in patients with pulmonary arterial hypertension. J Cardiopulm Rehabil Prev. 2008 Jan-Feb;28(1):12-6. doi: 10.1097/01.HCR.0000311502.57022.73. Erratum In: J Cardiopulm Rehabil Prev. 2008 Mar-Apr;28(2):table of contents.
Results Reference
result
PubMed Identifier
32229541
Citation
Hansen H, Bieler T, Beyer N, Kallemose T, Wilcke JT, Ostergaard LM, Frost Andeassen H, Martinez G, Lavesen M, Frolich A, Godtfredsen NS. Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial. Thorax. 2020 May;75(5):413-421. doi: 10.1136/thoraxjnl-2019-214246. Epub 2020 Mar 30.
Results Reference
result

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Telerehabilitation Program Via Videoconference PAH - Randomized Clinical Trial

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