Telerehabilitation Program Via Videoconference PAH - Randomized Clinical Trial

NCT05655481 | Unknown DMC

• 1 other identifier: PAH - Telerehabilitation
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension; Cardiovascular Diseases; Respiratory Disease Nursing; Hypertension, Pulmonary; Pulmonary Hypertension

Keywords

Exercise Functional Capacity; Pulmonary Arterial Hypertension; Telerehabilitation; Functional Capacity

Outcome Measures

Primary Outcomes (4)

• Functional exercise capacity

  Oxygen consumption measured during cardiopulmonary testing

  Change from baseline to 8 weeks

• 6 Minute Walking Test

  Distance in meters

  Change from baseline to 8 weeks

• Maximum heart rate

  Correlate the maximum heart rate of both functional capacity tests

  Change from baseline to 8 weeks

• 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 Outcomes (3)

• FVC

  Change from baseline to 8 weeks

• FEV1

  Change from baseline to 8 weeks

• Health-related quality of life score

  Change from baseline to 8 weeks

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

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

Telehealth

EXPERIMENTAL

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

Interventions

Aerobic and Resistance training with rehabilitation OTHER

Effects of home telerehabilitation program improve functional capacity variables

Telerehabilitation

Health education OTHER

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

Telehealth

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Luciana Maria Malosa Sampaio

São Paulo, São Paulo, 03332010, Brazil

Location

Related Publications (9)

• 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.

  PMID: 26185169 RESULT

• 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.

  PMID: 25896259 RESULT

• 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.

  PMID: 26231884 RESULT

• 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.

  PMID: 16982941 RESULT

• 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.

  PMID: 21694556 RESULT

• 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.

  PMID: 25269680 RESULT

• 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.

  PMID: 26873944 RESULT

• 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.

  PMID: 18277824 RESULT

• 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.

  PMID: 32229541 RESULT

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Cardiovascular Diseases; Hypertension, Pulmonary

Interventions

Resistance Training; Rehabilitation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Luciana Malosa Sampaio, Ph.D

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciana Malosa Sampaio, Ph.D

CONTACT

+5511996002075; lucianamalosa@gmail.com

Jonathan Luiz da Silva, M.Sc

CONTACT

+5511912549818; jhonathanluys42@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the Postgraduate Program in Rehabilitation Sciences

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 19, 2022
• Study Start: January 15, 2023
• Primary Completion: April 25, 2023
• Study Completion: May 10, 2025
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)