NCT03385733

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2018

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

December 21, 2017

Last Update Submit

February 28, 2018

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertensioninspiratory muscle trainingfunctional capacityphysical activity

Outcome Measures

Primary Outcomes (1)

  • mouth pressures

    MIP and MEP

    10 minutes

Secondary Outcomes (4)

  • International Physical Activity Questionnaire-Short Form

    10 minutes

  • Minnesota Living with Heart Failure Questionnaire

    15 minutes

  • Activity monitoring (Sense wear® Armband)

    3 days

  • 6 minute walking test

    15 minutes

Study Arms (2)

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

inspiratory muscle trainingOTHER

The treatment group received IMT. Patients were trained using an inspiratory threshold-loading device

Inspiratory muscle training group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • COPD
  • Conditions which can limit the assessments
  • Insufficient cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension, PulmonaryMotor Activity

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Goksen Kuran Aslan

    Istanbul University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will randomize into two groups as Group A: inspiratory muscle training, and Group B (control group)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Proff.

Study Record Dates

First Submitted

December 21, 2017

First Posted

December 28, 2017

Study Start

October 10, 2017

Primary Completion

February 15, 2018

Study Completion

February 15, 2018

Last Updated

March 1, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Results of the study will share with other researchers

Locations

TU(1)