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NCT Number: NCT04397133

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Physical Medicine Rehabilitation Traning and Research Hospital

Istanbul, 34100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory Muscle Training

Other

inspiratory muscle training will be done with Philips Respironics Threshold IMT device starting with resistance of % 50 of MIP value

Sham intervention

Other

in these group the patients will get sham intervention with Philips Respironics Threshold IMT device

Primary outcomes

  1. The change in maximal inspiratory pressure

    Time frame: Baseline and week 8,12, 24

    Measured with MicroRPM (respiratory pressure meter) pressurometer device orally

Secondary outcomes

  1. 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

  2. Pneumonia incidence

    Time frame: Week 24

    Number of participants with Pneumonia will be determined at week 24

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Collaborators

  • Istanbul Saglik Bilimleri University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 21, 2020
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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