Inspiratory Muscle Training in Pulmonary Hypertension

• Sponsor: Istanbul University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03385733
• Collaborator: Biruni University (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.2
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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)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: Oct 10, 2017
• Actual Primary Completion Date: Feb 15, 2018
• Actual Study Completion Date: Feb 15, 2018

Arms and Interventions

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

Primary Outcome Measures

1. mouth pressures [10 minutes]

   MIP and MEP

Secondary Outcome Measures

1. International Physical Activity Questionnaire-Short Form [10 minutes]

   Physical activity

2. Minnesota Living with Heart Failure Questionnaire [15 minutes]

   quality of life

3. Activity monitoring (Sense wear® Armband) [3 days]

   Metabolic holter

4. 6 minute walking test [15 minutes]

   functional capacity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Istanbul University	Istanbul		Turkey	34010

Sponsors and Collaborators

• Istanbul University
• Biruni University

Investigators

• Study Director: Goksen Kuran Aslan, Istanbul University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Goksen Kuran Aslan, Associated Proff., Istanbul University
• ClinicalTrials.gov Identifier: NCT03385733
• Other Study ID Numbers: GAslan; BuketA
• First Posted: Dec 28, 2017
• Last Update Posted: Mar 1, 2018
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Goksen Kuran Aslan, Associated Proff., Istanbul University: pulmonary hypertension; inspiratory muscle training; functional capacity; physical activity
• Additional relevant MeSH terms: Hypertension, Pulmonary; Respiratory Aspiration; Hypertension

Study Results

No Results Posted as of Mar 1, 2018