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Stroke, ComplicationNCT04397133

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

A study testing inspiratory muscle training in people with Stroke, Complication and Respiratory Complication, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
inspiratory muscle training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteTurkey (Türkiye)
Study dates
23 Dec 2019to 1 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Physical Medicine Rehabilitation Traning and Research Hospital

    Istanbul, 34100

Other trials in Turkey (Türkiye)

About this study

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

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

Read the detailed 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.

Being tested
inspiratory muscle training, sham intervention
Keywords
Breathing exercises, Cerebrovascular disease, Muscle strength, Rehabilitation, Stroke
Medical subject headings
Stroke, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • inspiratory muscle trainingOther

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

  • sham interventionOther

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

Study groups in NCT04397133
Study groupRoleWhat they receive
intervention 1Experimentalin this group patients will get 4 week of inspiratory muscle training exercise 30 minutes every weekday ( 15 minutes of two session in each day)
Receives: Other: inspiratory muscle training
intervention 2Experimentalin this group patients will get 8 week of inspiratory muscle training exercise 30 minutes every weekday ( 15 minutes of two session in each day)
Receives: Other: inspiratory muscle training
control groupSham comparatorthis group will get sham intervention with 0 to 5 cmH2O resistance
Receives: Other: sham intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change in maximal inspiratory pressure

    Measured with MicroRPM (respiratory pressure meter) pressurometer device orally

    Measured: Baseline and week 8,12, 24

Secondary outcomes (2)

  1. The change in walking capacity

    The change in walking capacity wil be measured with Six Minute Walk Test

    Measured: Baseline and week 8,12, 24

  2. Pneumonia incidence

    Number of participants with Pneumonia will be determined at week 24

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2020
  2. Study start23 Dec 2019
  3. Primary completion15 Mar 2021
  4. Study completion1 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04397133
Sponsor's protocol ID
IstPMRTRH-IMT-H
Status last verified
Jan 2024
First submitted
11 Nov 2019
Last updated
23 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 22568454

  • 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.

    PubMed 21272713

  • 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.

    PubMed 27271373

  • 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.

    PubMed 21876848

  • 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.

    PubMed 20156979

  • 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.

    PubMed 12601102

Questions about this trial

What is this clinical trial studying?

A study testing inspiratory muscle training in people with Stroke, Complication and Respiratory Complication, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in maximal inspiratory pressure (time frame: Baseline and week 8,12, 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04397133, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.

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