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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-23

Study Completion Date

2021-04-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Stroke, Complication Respiratory Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

three armed study with two interventions and one control group intervention group 1: inspiratory muscle training applied for 4 week intervention group 2: inspiratory muscle training applied for 8 week control group : will get sham intervention

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

the assessor who will investigate the results and the investigator who will perform the MIP and 6-minutes walking test will be blinded to the randomization

Study Groups

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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)

Group Type EXPERIMENTAL

inspiratory muscle training

Intervention Type OTHER

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

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)

Group Type EXPERIMENTAL

inspiratory muscle training

Intervention Type OTHER

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

control group

this group will get sham intervention with 0 to 5 cmH2O resistance

Group Type SHAM_COMPARATOR

sham intervention

Intervention Type OTHER

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

Interventions

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inspiratory muscle training

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

Intervention Type OTHER

sham intervention

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No