Telerehabilitation Program Via Videoconference PAH - Randomized Clinical Trial

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05655481
• Other study ID #: PAH - Telerehabilitation
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: May 10, 2025

Study information

• Verified date: December 2022
• Source: University of Nove de Julho
• Contact: Luciana Malosa Sampaio, Ph.D
• Phone: +5511996002075
• Email: lucianamalosa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 10, 2025
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Familial Primary Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension
• Pulmonary Hypertension
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Other:
• Aerobic and Resistance training with rehabilitation
Effects of home telerehabilitation program improve functional capacity variables
• Health education
Telehealth and guidelines for the practice of physical activity and health education

Locations

Country	Name	City	State
Brazil	Luciana Maria Malosa Sampaio	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

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. — View 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. — View 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 consump — View 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 cardiorespi — View 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 tria — View 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 Bord — View 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 a — View 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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional exercise capacity	Oxygen consumption measured during cardiopulmonary testing	Change from baseline to 8 weeks
Primary	6 Minute Walking Test	Distance in meters	Change from baseline to 8 weeks
Primary	Maximum heart rate	Correlate the maximum heart rate of both functional capacity tests	Change from baseline to 8 weeks
Primary	Interchangeable tests	Correlate the distance covered in the six-minute walk test with the number of climbs in the incremental step test	Change from baseline to 8 weeks
Secondary	FVC	Lung function - forced vital capacity	Change from baseline to 8 weeks
Secondary	FEV1	Lung function - expiratory volume in 1 second	Change from baseline to 8 weeks
Secondary	Health-related quality of life score	scores by EmPHasis-10- health-related quality of life Pulmonary hypertension. Score 0-50	Change from baseline to 8 weeks