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

Respiratory Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04397133
• Other study ID #: IstPMRTRH-IMT-H
• Status: Completed
• Phase: N/A
• Start date: December 23, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: January 2024
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 1, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Complication
• Stroke
• Stroke, Complication

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine Rehabilitation Traning and Research Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital	Istanbul Saglik Bilimleri University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Billinger SA, Coughenour E, Mackay-Lyons MJ, Ivey FM. Reduced cardiorespiratory fitness after stroke: biological consequences and exercise-induced adaptations. Stroke Res Treat. 2012;2012:959120. doi: 10.1155/2012/959120. Epub 2011 Aug 14. — View Citation

Britto RR, Rezende NR, Marinho KC, Torres JL, Parreira VF, Teixeira-Salmela LF. Inspiratory muscular training in chronic stroke survivors: a randomized controlled trial. Arch Phys Med Rehabil. 2011 Feb;92(2):184-90. doi: 10.1016/j.apmr.2010.09.029. — View Citation

Guillen-Sola A, Messagi Sartor M, Bofill Soler N, Duarte E, Barrera MC, Marco E. Respiratory muscle strength training and neuromuscular electrical stimulation in subacute dysphagic stroke patients: a randomized controlled trial. Clin Rehabil. 2017 Jun;31(6):761-771. doi: 10.1177/0269215516652446. Epub 2016 Jun 7. — View Citation

Katzan IL, Cebul RD, Husak SH, Dawson NV, Baker DW. The effect of pneumonia on mortality among patients hospitalized for acute stroke. Neurology. 2003 Feb 25;60(4):620-5. doi: 10.1212/01.wnl.0000046586.38284.60. — View Citation

Pollock RD, Rafferty GF, Moxham J, Kalra L. Respiratory muscle strength and training in stroke and neurology: a systematic review. Int J Stroke. 2013 Feb;8(2):124-30. doi: 10.1111/j.1747-4949.2012.00811.x. Epub 2012 May 9. — View Citation

Sutbeyaz ST, Koseoglu F, Inan L, Coskun O. Respiratory muscle training improves cardiopulmonary function and exercise tolerance in subjects with subacute stroke: a randomized controlled trial. Clin Rehabil. 2010 Mar;24(3):240-50. doi: 10.1177/0269215509358932. Epub 2010 Feb 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in maximal inspiratory pressure	Measured with MicroRPM (respiratory pressure meter) pressurometer device orally	Baseline and week 8,12, 24
Secondary	The change in walking capacity	The change in walking capacity wil be measured with Six Minute Walk Test	Baseline and week 8,12, 24
Secondary	Pneumonia incidence	Number of participants with Pneumonia will be determined at week 24	Week 24