ClinicalTrials.gg
CompletedNCT03385733Updated Mar 1, 2018

Inspiratory Muscle Training in Pulmonary Hypertension

An interventional study of inspiratory muscle training in Pulmonary Hypertension, sponsored by Istanbul University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-03-01.

Sponsored by Istanbul University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 46 studies in Hypertension, Pulmonary with a site in Turkey — 6 open to participants now, 13 under way, 4 of them phase 3. Hypertension, Pulmonary · Turkey.

Enrollment
23rd of 28
30 · median 129
Started
2017
with 1 other
No phase
8 of 46
1 open now
Registered
21st of 46
by date
Lead sponsor
3 of 46
Istanbul University

Among the 46 studies in Hypertension, Pulmonary with a site in Turkey, this one is the 23rd largest by enrollment of the 28 interventional ones that give a count, is one of 2 that started in 2017, is one of 8 with no phase, and was the 21st registered.

Hypertension, Pulmonary

1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.

Browse Hypertension, Pulmonary studies →

Open to participants now

6 of the 46 studies in Hypertension, Pulmonary with a site in Turkey are open now. Recruiting first, the newest first:

1 more — sign in →

All 6 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 164 Hypertension, Pulmonary studies recruiting now, 100 (61%) set no upper age limit and 26 (16%) stop at 75 or younger; 39 take children under 18; 24 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Pulmonary Hypertension

Keywords

  • pulmonary hypertension
  • inspiratory muscle training
  • functional capacity
  • physical activity
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Conditions which can limit the assessments
  • Insufficient cooperation
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • 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

  • No intervention
    control group

    Patients will continue 8 weeks, 5 days, 2 times 15 minutes training program with 9 cmH2O pressure at home.

Interventions

  • Otherinspiratory muscle training

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

06

What researchers measure

Primary outcomes

  1. mouth pressures

    MIP and MEP

    Time frame: 10 minutes

Secondary outcomes

  1. International Physical Activity Questionnaire-Short Form

    Physical activity

    Time frame: 10 minutes

  2. Minnesota Living with Heart Failure Questionnaire

    quality of life

    Time frame: 15 minutes

  3. Activity monitoring (Sense wear® Armband)

    Metabolic holter

    Time frame: 3 days

  4. 6 minute walking test

    functional capacity

    Time frame: 15 minutes

07

Study locations

1 site
  • Istanbul University
    Istanbul, 34010, Turkey
08

References and documents

Individual participant data

Plan to share: No — Results of the study will share with other researchers

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Feb 2018, 4 months.

Of 134 non-industry interventional studies with no phase under Hypertension, Pulmonary, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 46. This study's 4 months is below that.

Counting every sponsor, half of 148 studies reached it within 23 months; a quarter within 9 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 21, 2017
First posted
Dec 28, 2017
StartActual
Oct 10, 2017
Primary completionActual
Feb 15, 2018
CompletionActual
Feb 15, 2018
Last update
Mar 1, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03385733
Collaborators
Biruni University
Responsible party
Goksen Kuran Aslan (Associated Proff., Istanbul University) — Principal investigator
First posted
Dec 28, 2017
Start date
Oct 10, 2017
Primary completion
Feb 15, 2018
Completion
Feb 15, 2018
Last update
Mar 1, 2018

Study contacts

Goksen Kuran Aslan
study director · Istanbul University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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