ClinicalTrials.gg
Sign In
CompletedNCT02270333Updated Oct 21, 2014

Inspiratory Muscle Training in Sarcoidosis

An interventional study of Inspiratory muscle training and Sham inspiratory muscle training in Sarcoidosis, sponsored by Gazi University. Completed. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-10-21.

Sponsored by Gazi University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study summary

Respiratory muscle weakness results with decreased exercise capacity, worse fatigue, dyspnea and quality of life in patients with sarcoidosis. However, no study investigated the effects of inspiratory muscle training (IMT), therefore effects of IMT on outcomes in patients with sarcoidosis were investigated.

Read the detailed description

Patients were diagnosed with sarcoidosis according to the criteria of the latest American Thoracic Society (ATS)/European Respiratory Society (ERS)/World Association of Sarcoidosis and Other Granulomatous (WASOG) Disorders statement on sarcoidosis. Primary outcome measurement was respiratory muscle strength, secondary outcomes were, exercise capacity quality of life, fatigue and depression.

02

Conditions studied

  • Sarcoidosis

Browse trials for

Keywords

  • sarcoidosis
  • inspiratory muscle strength
  • exercise capacity
  • quality of life
03

In context

Sarcoidosis

285 studies on the registry are indexed under Sarcoidosis; 58 are open to participants now.

This study's enrollment of 30 is below the median of 54 across 158 interventional studies indexed under Sarcoidosis.

Browse Sarcoidosis studies →

Lead sponsor

Gazi University is the lead sponsor of 548 studies on the registry; 104 are open to participants now.

Browse Gazi University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinically stable
  • Under standard medication
  • Stage I and IV
  • No change in medications over three months

Exclusion criteria

Exclusion Criteria:

  • Cognitive disorders
  • Current corticosteroid use
  • Having co-morbidity to prevent performing IMT
  • Acute infection
  • Orthopedic and neurological problems
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Treatment group

    Intervention: Treatment group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device .

    Device: Inspiratory muscle training

  • Sham comparator
    Control group

    Sham: Control group received sham inspiratory muscle training using POWERbreathe Classic threshold loading device .

    Device: Sham inspiratory muscle training

Interventions

  • DeviceInspiratory muscle training

    Treatment group received inspiratory muscle training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 40% of maximal inspiratory pressure (MIP). The MIP was measured at supervised session each week, and 40% of measured MIP value was the new training workload. The treatment group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department.

  • DeviceSham inspiratory muscle training

    Control group received sham inspiratory muscle training (IMT) at fixed workload, 5% of MIP using threshold loading device (POWERbreathe Classic device IMT Technologies Ltd. Birmingham, England). The control group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department.

06

What researchers measure

Primary outcomes

  1. Maximum inspiratory and expiratory muscle strength (MIP, MEP)

    Mouth pressure device

    Time frame: 6 weeks

Secondary outcomes

  1. Exercise Capacity

    Six-minute walk test (6MWT)

    Time frame: 6 weeks

  2. Maximal Exercise Capacity

    Modified incremental shuttle walk test (ISWT)

    Time frame: 6 weeks

  3. Fatigue

    Fatigue Severity Scale (FSS)

    Time frame: 6 weeks

  4. Pulmonary function and diffusing capacity

    Spirometry

    Time frame: 6 weeks

  5. Peripheral muscle strength

    Hand-held dynamometer

    Time frame: 6 weeks

  6. Dyspnea

    Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales

    Time frame: 6 weeks

  7. Depression

    Montgomery Asberg Depression Rating Scale (MADRS))

    Time frame: 6 weeks

  8. Quality of life

    Saint George's Respiratory Questionnaire (SGRQ) (Turkish versions of all scales)

    Time frame: 6 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Spruit MA, Thomeer MJ, Gosselink R, Troosters T, Kasran A, Debrock AJ, Demedts MG, Decramer M. Skeletal muscle weakness in patients with sarcoidosis and its relationship with exercise intolerance and reduced health status. Thorax. 2005 Jan;60(1):32-8. doi: 10.1136/thx.2004.022244. PubMed 15618580 ↗
  • Kabitz HJ, Lang F, Walterspacher S, Sorichter S, Muller-Quernheim J, Windisch W. Impact of impaired inspiratory muscle strength on dyspnea and walking capacity in sarcoidosis. Chest. 2006 Nov;130(5):1496-502. doi: 10.1378/chest.130.5.1496. PubMed 17099029 ↗
  • Baydur A, Alsalek M, Louie SG, Sharma OP. Respiratory muscle strength, lung function, and dyspnea in patients with sarcoidosis. Chest. 2001 Jul;120(1):102-8. doi: 10.1378/chest.120.1.102. PubMed 11451823 ↗
  • Wirnsberger RM, Drent M, Hekelaar N, Breteler MH, Drent S, Wouters EF, Dekhuijzen PN. Relationship between respiratory muscle function and quality of life in sarcoidosis. Eur Respir J. 1997 Jul;10(7):1450-5. doi: 10.1183/09031936.97.10071450. PubMed 9230229 ↗
  • Karadalli MN, Bosnak-Guclu M, Camcioglu B, Kokturk N, Turktas H. Effects of Inspiratory Muscle Training in Subjects With Sarcoidosis: A Randomized Controlled Clinical Trial. Respir Care. 2016 Apr;61(4):483-94. doi: 10.4187/respcare.04312. Epub 2015 Dec 29. PubMed 26715771 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2012, a primary completion of Sep 2013 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2014
First posted
Oct 21, 2014
Start
Apr 2012
Primary completionActual
Sep 2013
CompletionActual
Apr 2014
Last update
Oct 21, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02270333
Lead sponsor
Gazi University
Responsible party
Meral Boşnak Güçlü (Assoc. Prof., Gazi University) — Principal investigator
First posted
Oct 21, 2014
Start date
Apr 2012
Primary completion
Sep 2013
Completion
Apr 2014
Last update
Oct 21, 2014

Study contacts

Müşerrefe Nur Karadallı, MSc.
study chair · Gazi University
Burcu Camcıoğlu, MSc.
principal investigator · Gazi University
Meral Boşnak Güçlü, PhD
study director · Gazi University
Nurdan Köktürk, MD
principal investigator · Gazi University
Haluk Türktaş, MD
principal investigator · Gazi University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Sarcoidosis →

Other studies from this sponsor

Gazi University →

Start the discussion