NCT03186092

Brief Summary

Pulmonary hypertension (HP) is a progressive pathological condition presents with vascular changes in the lung. Cardiopulmonary changes in PH are considered the main limiting factor, however, it is known that the muscular alterations potentiate the symptomatology. Several HP factors and mechanisms have an impact on peripheral and respiratory muscle changes, so, specifically, respiratory muscles are also altered in patients with PH. In the face of respiratory muscle weakness, inspiratory muscle training (IMT) has been shown to increase respiratory muscle strength and functional capacity in chronic conditions such as obstructive pulmonary disease (COPD) and heart failure (HF). The objective of this study is to test whether a 12-week TMI protocol is capable of impacting functional capacity, respiratory muscle strength, spirometric values and quality of life in patients with PH.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2020

Completed
Last Updated

February 5, 2021

Status Verified

November 1, 2019

Enrollment Period

7 months

First QC Date

June 12, 2017

Last Update Submit

February 2, 2021

Conditions

Respiratory Muscle Strength

Keywords

Respiratory muscle strengthPulmonary hypertensionRespiratory muscle training

Outcome Measures

Primary Outcomes (2)

  • Respiratory muscle strength

    Inspiratory Muscle strength

    3 months

  • Walk test

    6 minute distance walk test

    3 months

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

inspiratory muscle training with load

Other: respiratory muscle training

Control Group

SHAM COMPARATOR

unloaded inspiratory muscle training

Other: sham muscle training

Interventions

respiratory muscle trainingOTHER

The TMI protocol will be performed with POWERbreathe Line Plus (POWERbreathe International Ltd. Warwickshire, England) linear loader with resistance load of 30% of maximal inspiratory pressure (PImax) value for a period of 12 weeks, 7 times at Week, 30 min / day, one of the times in the week with the supervision of the researcher and, on the other six days of the week, patients will perform IMT at their homes, having as a control a records record of the protocol that will be delivered to each patient To record the time and duration of the exercise. At the end of each week, patients will be reevaluated for MIP, so that the load values are regulated according to the possible increase in inspiratory muscle strength. The data collection will be performed by a single evaluator and the patients will be properly oriented on the procedures to be performed.

Intervention Group
sham muscle trainingOTHER

sham comparator

Control Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pulmonary hypertension (PAP m ≥ 25mmHg and PAOP \<15mmHg);
  • both sexes and age greater than or equal to 18 years;
  • Clinically stable with optimized and unchanged daily drug therapy in the last three months;
  • agree to participate in the study by signing a free and informed consent form

You may not qualify if:

  • Down's syndrome
  • COPD
  • Severe ischemic heart disease
  • Left heart failure
  • Cor pulmonale
  • Cognitive Disorders
  • Orthopedic problems that interfere with assessments and interventions
  • Emergency or elective surgical intervention during the protocol
  • Pulmonary infectious process during the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Casa of Sao Paulo Medical School

São Paulo, 01221-020, Brazil

Location

Related Publications (10)

  • Hoeper MM, Bogaard HJ, Condliffe R, Frantz R, Khanna D, Kurzyna M, Langleben D, Manes A, Satoh T, Torres F, Wilkins MR, Badesch DB. Definitions and diagnosis of pulmonary hypertension. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D42-50. doi: 10.1016/j.jacc.2013.10.032.

    PMID: 24355641RESULT

  • Simonneau G, Gatzoulis MA, Adatia I, Celermajer D, Denton C, Ghofrani A, Gomez Sanchez MA, Krishna Kumar R, Landzberg M, Machado RF, Olschewski H, Robbins IM, Souza R. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D34-41. doi: 10.1016/j.jacc.2013.10.029.

    PMID: 24355639RESULT

  • Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Respir J. 2015 Oct;46(4):903-75. doi: 10.1183/13993003.01032-2015. Epub 2015 Aug 29.

    PMID: 26318161RESULT

  • Ehlken N, Verduyn C, Tiede H, Staehler G, Karger G, Nechwatal R, Opitz CF, Klose H, Wilkens H, Rosenkranz S, Halank M, Grunig E. Economic evaluation of exercise training in patients with pulmonary hypertension. Lung. 2014 Jun;192(3):359-66. doi: 10.1007/s00408-014-9558-9. Epub 2014 Mar 8.

    PMID: 24609926RESULT

  • Gosselink R, De Vos J, van den Heuvel SP, Segers J, Decramer M, Kwakkel G. Impact of inspiratory muscle training in patients with COPD: what is the evidence? Eur Respir J. 2011 Feb;37(2):416-25. doi: 10.1183/09031936.00031810.

    PMID: 21282809RESULT

  • ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

    PMID: 12091180RESULT

  • Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007.

    PMID: 10412550RESULT

  • Simonneau G, Galie N, Rubin LJ, Langleben D, Seeger W, Domenighetti G, Gibbs S, Lebrec D, Speich R, Beghetti M, Rich S, Fishman A. Clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2004 Jun 16;43(12 Suppl S):5S-12S. doi: 10.1016/j.jacc.2004.02.037.

    PMID: 15194173RESULT

  • 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: 16982941RESULT

  • Saglam M, Arikan H, Vardar-Yagli N, Calik-Kutukcu E, Inal-Ince D, Savci S, Akdogan A, Yokusoglu M, Kaya EB, Tokgozoglu L. Inspiratory muscle training in pulmonary arterial hypertension. J Cardiopulm Rehabil Prev. 2015 May-Jun;35(3):198-206. doi: 10.1097/HCR.0000000000000117.

    PMID: 25909652RESULT

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The equipment is the same for both groups. The change is internal, in the placebo group, patients train without a spring that imposes the load for respiratory muscle training.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Health Science and Head of Cardiorespiratory Physiotherapy

Study Record Dates

First Submitted

June 12, 2017

First Posted

June 14, 2017

Study Start

August 1, 2017

Primary Completion

March 1, 2018

Study Completion

December 10, 2020

Last Updated

February 5, 2021

Record last verified: 2019-11

Locations

BR(1)