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SarcoidosisNCT02270333

Inspiratory Muscle Training in Sarcoidosis

A study testing Inspiratory muscle training in people with Sarcoidosis, run by Gazi University.

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

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 more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Sarcoidosis
What is being tested?
Inspiratory muscle training
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
No sites listed yet
Study dates
Apr 2012to Apr 2014
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: Effects of Inspiratory Muscle Training in Patients With Sarcoidosis

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.

Conditions
Sarcoidosis
Being tested
Inspiratory muscle training, Sham inspiratory muscle training
Keywords
sarcoidosis, inspiratory muscle strength, exercise capacity, quality of life
Medical subject headings
Sarcoidosis

What participants receive

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

  • Inspiratory muscle trainingDevice

    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.

  • Sham inspiratory muscle trainingDevice

    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.

Study groups in NCT02270333
Study groupRoleWhat they receive
Treatment groupActive comparatorIntervention: Treatment group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device .
Receives: Device: Inspiratory muscle training
Control groupSham comparatorSham: Control group received sham inspiratory muscle training using POWERbreathe Classic threshold loading device .
Receives: Device: Sham inspiratory muscle training

What is being measured

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

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

    Mouth pressure device

    Measured: 6 weeks

Secondary outcomes (8)

  1. Exercise Capacity

    Six-minute walk test (6MWT)

    Measured: 6 weeks

  2. Maximal Exercise Capacity

    Modified incremental shuttle walk test (ISWT)

    Measured: 6 weeks

  3. Fatigue

    Fatigue Severity Scale (FSS)

    Measured: 6 weeks

  4. Pulmonary function and diffusing capacity

    Spirometry

    Measured: 6 weeks

  5. Peripheral muscle strength

    Hand-held dynamometer

    Measured: 6 weeks

  6. Dyspnea

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

    Measured: 6 weeks

  7. Depression

    Montgomery Asberg Depression Rating Scale (MADRS))

    Measured: 6 weeks

  8. Quality of life

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

    Measured: 6 weeks

Timeline

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

  1. First posted21 Oct 2014 (estimated)
  2. Study startApr 2012
  3. Primary completionSep 2013
  4. Study completionApr 2014

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02270333
Sponsor's protocol ID
GaziU
Status last verified
Oct 2014
First submitted
8 Oct 2014
Last updated
21 Oct 2014
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Inspiratory muscle training in people with Sarcoidosis, run by Gazi University.

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 5 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 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

Maximum inspiratory and expiratory muscle strength (MIP, MEP) (time frame: 6 weeks). 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 NCT02270333, which also lists 5 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 21 Oct 2014.

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