Inspiratory Muscle Training in Pulmonary Hypertension | NCT03385733

Studies
Inspiratory Muscle Training in Pulmonary Hypertension

NCT03385733

Sponsor

Istanbul University

Status

Completed

Last Update Posted

Mar 1, 2018Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Pulmonary Hypertension

Interventions

inspiratory muscle training

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
BuketA	Other Identifier	BiruniU

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2017Actual

Primary Completion Date

Feb 15, 2018Actual

Completion Date

Feb 15, 2018Actual

First Submitted Date

Dec 21, 2017

First Submission Date that Met QC Criteria

Dec 21, 2017

First Posted Date

Dec 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2018

Last Update Posted Date

Mar 1, 2018Actual

Name	Class
Biruni University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Inspiratory muscle training group	Experimental	Patients will continue 8 weeks, 5 days, 2 times 15 minutes training program with %30 MIP at home.	Other: inspiratory muscle training
control group	No Intervention	Patients will continue 8 weeks, 5 days, 2 times 15 minutes training program with 9 cmH2O pressure at home.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
inspiratory muscle training	Other	The treatment group received IMT. Patients were trained using an inspiratory threshold-loading device	Inspiratory muscle training group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mouth pressures	MIP and MEP	10 minutes

Secondary Outcomes

Measure	Description	Time Frame
International Physical Activity Questionnaire-Short Form	Physical activity	10 minutes
Minnesota Living with Heart Failure Questionnaire	quality of life

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Goksen Kuran Aslan	Istanbul University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul University		Istanbul		34010	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Results of the study will share with other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary
D009043	Motor Activity

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided