The Optimal Treatment Duration for Inspiratory Muscle Strengthening Exercises in Stroke Patients

January 20, 2024 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

The Optimal Treatment Duration for Inspiratory Muscle Strengthening Exercises in Stroke Patients: A Double-blind Randomised Controlled Trial

The first aim of this study is if there is any difference between 4 or 8 weeks of inspiratory muscle training ( IMT ) exercises groups and control groups in stroke survivors. The secondary aims of this study is if there is any difference in walking capacity (in 8th, 12th, 24th weeks) and pulmonary complications (pneumonia incidences) in long term follow-ups (6 months) in these aforementioned groups

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stroke is one of the leading causes of death and disability. It is not only because of loss of extremity motions but also loss of inspiratory muscle strength. In this study we aimed to determine the optimum duration for inspiratory muscle training exercises for stroke survivors since there is not enough data about it in the literature.

The study will include at least 54 patients in total and 18 in each groups ( two intervention and one control) . The patients will be evaluated for angina, chronic obstructive pulmonary disease, congestive heart disease; in these conditions the patients will be excluded from the study. Also in first examinations we will evaluate the maximal inspiratory pressure (MIP) of patients, of them the ones with MIP measurements above 80 mmH2O will also be excluded since it is the expected value in normal people.

After admission and randomizing the patients, baseline measurements of MIP, 6-minutes walking test will be done. In intervention groups the patients will get 30 minutes of inspiratory muscle training exercises ( 15 minutes of two session each day) with threshold IMT device every weekday. And in control group, the patients will get sham intervention for 8 weeks. The MIP and 6-minutes walking test will be done in 8th,12th and 24th weeks. And also in 24th week we will record the pneumonia incidence if occured.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34100
        • Istanbul Physical Medicine Rehabilitation Traning and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ischemic/ hemorrhagic stroke
  • Stroke duration> 3 months
  • Age> 18 years old
  • Baseline maximal inspiratory pressure below 80 cmH2O

Exclusion Criteria:

  • Cognitive deficiency
  • Facial paralysis
  • Chronic obstructive pulmonary disease
  • Congestive heart disease
  • Myocardial infarction in last three months
  • Angina pectoris

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention 1
in this group patients will get 4 week of inspiratory muscle training exercise 30 minutes every weekday ( 15 minutes of two session in each day)
Other: inspiratory muscle training
inspiratory muscle training will be done with Philips Respironics Threshold IMT device starting with resistance of % 50 of MIP value
Experimental: intervention 2
in this group patients will get 8 week of inspiratory muscle training exercise 30 minutes every weekday ( 15 minutes of two session in each day)
Other: inspiratory muscle training
inspiratory muscle training will be done with Philips Respironics Threshold IMT device starting with resistance of % 50 of MIP value
Sham Comparator: control group
this group will get sham intervention with 0 to 5 cmH2O resistance
Other: sham intervention
in these group the patients will get sham intervention with Philips Respironics Threshold IMT device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in maximal inspiratory pressure
Time Frame: Baseline and week 8,12, 24
Measured with MicroRPM (respiratory pressure meter) pressurometer device orally
Baseline and week 8,12, 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in walking capacity
Time Frame: Baseline and week 8,12, 24
The change in walking capacity wil be measured with Six Minute Walk Test
Baseline and week 8,12, 24
Pneumonia incidence
Time Frame: Week 24
Number of participants with Pneumonia will be determined at week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Collaborators

Istanbul Saglik Bilimleri University

Investigators

  • Principal Investigator: Yunus Emre Doğan, MD, Istanbul Physical Medicine Rehabilitation Traning and Research Hospital
  • Principal Investigator: Burak Kütük, MD, Istanbul Physical Medicine Rehabilitation Traning and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2019

Primary Completion (Actual)

March 15, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

May 17, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 20, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstPMRTRH-IMT-H

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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