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Effects of Training in Pulmonary Hypertension

Primary Purpose

Respiratory Muscle Strength

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
respiratory muscle training
sham muscle training
Sponsored by
Faculdade de Ciências Médicas da Santa Casa de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Muscle Strength focused on measuring Respiratory muscle strength, Pulmonary hypertension, Respiratory muscle training

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Santa Casa of Sao Paulo Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Intervention Group

Control Group

Arm Description

inspiratory muscle training with load

unloaded inspiratory muscle training

Outcomes

Primary Outcome Measures

Respiratory muscle strength
Inspiratory Muscle strength
Walk test
6 minute distance walk test

Secondary Outcome Measures

Full Information

First Posted
June 12, 2017
Last Updated
February 2, 2021
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03186092
Brief Title
Effects of Training in Pulmonary Hypertension
Official Title
Effects of Respiratory Muscle Training on Respiratory Muscle Strength, Functional Capacity and Quality of Life in Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
December 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo

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 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.
Detailed Description
Pulmonary hypertension (HP) is a progressive pathological condition that HP presents with vascular changes in the lung that cause proliferative and obstructive remodeling promoting vasoconstriction with a consequent increase in pulmonary vascular resistance (PVR). 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, such as: decreased cardiac output, hypoxemia, inflammation, increased insulin resistance, altered autonomic nervous system (ANS) response, and muscle disuse. These factors imply alteration of fiber type, atrophy, capillary vascular reduction, reduction of oxidative capacity, endothelial dysfunction and decreased muscle excitability by ANS. Specifically, respiratory muscles are also altered in patients with PH. For the treatment of PH, in addition to optimized drug therapy, studies have demonstrated the effects of physical exercise for this population. Although there is no consensus about the best exercise modality, duration, frequency or intensity, physical training promotes benefits in exercise capacity, maximal oxygen capacity (VO2peak) and quality of life. The most recent European guideline [3] recommends supervised exercise in patients with PH who are clinically stable with optimized drug therapy (evidence grade IIa, Level B), but patients often do not have access to supervised physical rehabilitation programs, which Practice a challenge. 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). At HP, the study by Saglam M et al., 2015 demonstrates improvement of respiratory muscle strength and functional capacity, resulting in decreased dyspnea and fatigue in PH patients who performed the IMT protocol during six weeks of outpatient training. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Muscle Strength
Keywords
Respiratory muscle strength, Pulmonary hypertension, Respiratory muscle training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
inspiratory muscle training with load
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
unloaded inspiratory muscle training
Intervention Type
Other
Intervention Name(s)
respiratory muscle training
Intervention Description
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 Type
Other
Intervention Name(s)
sham muscle training
Intervention Description
sham comparator
Primary Outcome Measure Information:
Title
Respiratory muscle strength
Description
Inspiratory Muscle strength
Time Frame
3 months
Title
Walk test
Description
6 minute distance walk test
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
Santa Casa of Sao Paulo Medical School
City
Sao Paulo
ZIP/Postal Code
01221-020
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24355641
Citation
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.
Results Reference
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PubMed Identifier
24355639
Citation
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. Erratum In: J Am Coll Cardiol. 2014 Feb 25;63(7):746. J Am Coll Cardiol. 2014 Feb 25;63(7):746.
Results Reference
result
PubMed Identifier
26318161
Citation
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. Erratum In: Eur Respir J. 2015 Dec;46(6):1855-6.
Results Reference
result
PubMed Identifier
24609926
Citation
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.
Results Reference
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PubMed Identifier
21282809
Citation
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.
Results Reference
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PubMed Identifier
12091180
Citation
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. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
Results Reference
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PubMed Identifier
10412550
Citation
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.
Results Reference
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PubMed Identifier
15194173
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Results Reference
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Effects of Training in Pulmonary Hypertension

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