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Inspiratory Muscle Training in Sarcoidosis

Primary Purpose

Sarcoidosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inspiratory muscle training
Sham inspiratory muscle training
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sarcoidosis focused on measuring sarcoidosis, inspiratory muscle strength, exercise capacity, quality of life

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Treatment group

    Control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Maximum inspiratory and expiratory muscle strength (MIP, MEP)
    Mouth pressure device

    Secondary Outcome Measures

    Exercise Capacity
    Six-minute walk test (6MWT)
    Maximal Exercise Capacity
    Modified incremental shuttle walk test (ISWT)
    Fatigue
    Fatigue Severity Scale (FSS)
    Pulmonary function and diffusing capacity
    Spirometry
    Peripheral muscle strength
    Hand-held dynamometer
    Dyspnea
    Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales
    Depression
    Montgomery Asberg Depression Rating Scale (MADRS))
    Quality of life
    Saint George's Respiratory Questionnaire (SGRQ) (Turkish versions of all scales)

    Full Information

    First Posted
    October 8, 2014
    Last Updated
    October 18, 2014
    Sponsor
    Gazi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02270333
    Brief Title
    Inspiratory Muscle Training in Sarcoidosis
    Official Title
    Effects of Inspiratory Muscle Training in Patients With Sarcoidosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gazi University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcoidosis
    Keywords
    sarcoidosis, inspiratory muscle strength, exercise capacity, quality of life

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment group
    Arm Type
    Active Comparator
    Arm Description
    Intervention: Treatment group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device .
    Arm Title
    Control group
    Arm Type
    Sham Comparator
    Arm Description
    Sham: Control group received sham inspiratory muscle training using POWERbreathe Classic threshold loading device .
    Intervention Type
    Device
    Intervention Name(s)
    Inspiratory muscle training
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Sham inspiratory muscle training
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Maximum inspiratory and expiratory muscle strength (MIP, MEP)
    Description
    Mouth pressure device
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Exercise Capacity
    Description
    Six-minute walk test (6MWT)
    Time Frame
    6 weeks
    Title
    Maximal Exercise Capacity
    Description
    Modified incremental shuttle walk test (ISWT)
    Time Frame
    6 weeks
    Title
    Fatigue
    Description
    Fatigue Severity Scale (FSS)
    Time Frame
    6 weeks
    Title
    Pulmonary function and diffusing capacity
    Description
    Spirometry
    Time Frame
    6 weeks
    Title
    Peripheral muscle strength
    Description
    Hand-held dynamometer
    Time Frame
    6 weeks
    Title
    Dyspnea
    Description
    Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales
    Time Frame
    6 weeks
    Title
    Depression
    Description
    Montgomery Asberg Depression Rating Scale (MADRS))
    Time Frame
    6 weeks
    Title
    Quality of life
    Description
    Saint George's Respiratory Questionnaire (SGRQ) (Turkish versions of all scales)
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinically stable Under standard medication Stage I and IV No change in medications over three months Exclusion Criteria: Cognitive disorders Current corticosteroid use Having co-morbidity to prevent performing IMT Acute infection Orthopedic and neurological problems
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Müşerrefe Nur Karadallı, MSc.
    Organizational Affiliation
    Gazi University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Burcu Camcıoğlu, MSc.
    Organizational Affiliation
    Gazi University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Meral Boşnak Güçlü, PhD
    Organizational Affiliation
    Gazi University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Nurdan Köktürk, MD
    Organizational Affiliation
    Gazi University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Haluk Türktaş, MD
    Organizational Affiliation
    Gazi University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15618580
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    17099029
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    11451823
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    9230229
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    26715771
    Citation
    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.
    Results Reference
    derived

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    Inspiratory Muscle Training in Sarcoidosis

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