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Inspiratory Muscle Training in Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT03385733
Recruitment Status : Completed
First Posted : December 28, 2017
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
Biruni University
Information provided by (Responsible Party):
Goksen Kuran Aslan, Istanbul University

Study Description
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Brief Summary:
The aim of this study is to investigate the effective of inspiratory muscle training on respiratory function, exercise capacity, physical activity and quality of life.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Other: inspiratory muscle training Not Applicable

Detailed Description:
Pulmonary hypertension (PH) is a condition which is seen with hemodynamic differences, pulmonary vascular resistance and right heart failure. Patients with pulmonary hypertension have, dyspnea, physical inactivity, reduced condition and respiratory muscle dysfunction. Aerobic exercise programs in patients with pulmonary hypertension are reported to result in improved exercise capacity and endurance of the patients, improvement in WHO functional class and quality of life, increased peak workload and increased peripheral muscle function. In recent years, few studies have investigated the efficacy of inspiratory muscle training in patients with PH.The aim of this study is to investigate the effective of inspiratory muscle training on respiratory function, exercise capacity, physical activity and quality of life.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will randomize into two groups as Group A: inspiratory muscle training, and Group B (control group)
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Inspiratory Muscle Training on Exercise Capacity, Physical Activity and Quality of Life in Pulmonary Hypertension
Actual Study Start Date : October 10, 2017
Actual Primary Completion Date : February 15, 2018
Actual Study Completion Date : February 15, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Inspiratory muscle training group
Patients will continue 8 weeks, 5 days, 2 times 15 minutes training program with %30 MIP at home.
 Other: inspiratory muscle training
The treatment group received IMT. Patients were trained using an inspiratory threshold-loading device
No Intervention: control group
Patients will continue 8 weeks, 5 days, 2 times 15 minutes training program with 9 cmH2O pressure at home.


Outcome Measures
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Primary Outcome Measures :
  1. mouth pressures [ Time Frame: 10 minutes ]
    MIP and MEP


Secondary Outcome Measures :
  1. International Physical Activity Questionnaire-Short Form [ Time Frame: 10 minutes ]
    Physical activity

  2. Minnesota Living with Heart Failure Questionnaire [ Time Frame: 15 minutes ]
    quality of life

  3. Activity monitoring (Sense wear® Armband) [ Time Frame: 3 days ]
    Metabolic holter

  4. 6 minute walking test [ Time Frame: 15 minutes ]
    functional capacity


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Pulmonary Hypertension,
  • NYHA functional class I-IV
  • MIP pressure <80 cm h2O

Exclusion Criteria:

  • COPD
  • Conditions which can limit the assessments
  • Insufficient cooperation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385733


Locations
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Turkey
Istanbul University
Istanbul, Turkey, 34010
Sponsors and Collaborators
Istanbul University
Biruni University
Investigators
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Study Director: Goksen Kuran Aslan Istanbul University
More Information
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Responsible Party: Goksen Kuran Aslan, Associated Proff., Istanbul University
ClinicalTrials.gov Identifier: NCT03385733    
Other Study ID Numbers: GAslan
BuketA ( Other Identifier: BiruniU )
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Results of the study will share with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Goksen Kuran Aslan, Istanbul University:
pulmonary hypertension
inspiratory muscle training
functional capacity
physical activity
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Respiratory Aspiration
Hypertension
Vascular Diseases
Cardiovascular Diseases
 Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes