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

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Status: Completed

Conditions: Stroke, Complication; Respiratory Complication

Treatments: Other: inspiratory muscle training; Other: sham intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04397133

IstPMRTRH-IMT-H

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

54 participants in 3 patient groups

intervention 1

Experimental group

Description:

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)

Treatment:

Other: inspiratory muscle training

intervention 2

Experimental group

Description:

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)

Treatment:

Other: inspiratory muscle training

control group

Sham Comparator group

Description:

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

Treatment:

Other: sham intervention