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

NCT04397133 | Completed

• 1 other identifier: IstPMRTRH-IMT-H
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Stroke, Complication; Respiratory Complication

Keywords

Breathing exercises; Cerebrovascular disease; Muscle strength; Rehabilitation; Stroke

Outcome Measures

Primary Outcomes (1)

• The change in maximal inspiratory pressure

  Measured with MicroRPM (respiratory pressure meter) pressurometer device orally

  Baseline and week 8,12, 24

Secondary Outcomes (2)

• The change in walking capacity

  Baseline and week 8,12, 24

• Pneumonia incidence

  Week 24

Study Arms (3)

intervention 1

EXPERIMENTAL

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

intervention 2

EXPERIMENTAL

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

control group

SHAM COMPARATOR

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

Other: sham intervention

Interventions

inspiratory muscle training OTHER

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

intervention 1; intervention 2

sham intervention OTHER

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

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead
• Istanbul Saglik Bilimleri University: collaborator

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Traning and Research Hospital

Istanbul, 34100, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 22568454 BACKGROUND

• 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.

  PMID: 21272713 BACKGROUND

• 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.

  PMID: 27271373 BACKGROUND

• 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.

  PMID: 21876848 BACKGROUND

• 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.

  PMID: 20156979 BACKGROUND

• 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.

  PMID: 12601102 BACKGROUND

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: May 21, 2020
• Study Start: December 23, 2019
• Primary Completion: March 15, 2021
• Study Completion: April 1, 2021
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

TU (1)