Skip to main content
OpenTrials
Completed

NCT Number: NCT02270333

Inspiratory Muscle Training in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory muscle training

Device

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 Training

Device

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 outcomes

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

    Time frame: 6 weeks

    Mouth pressure device

Secondary outcomes

  1. Exercise Capacity

    Time frame: 6 weeks

    Six-minute walk test (6MWT)

  2. Maximal Exercise Capacity

    Time frame: 6 weeks

    Modified incremental shuttle walk test (ISWT)

  3. Fatigue

    Time frame: 6 weeks

    Fatigue Severity Scale (FSS)

  4. Pulmonary function and diffusing capacity

    Time frame: 6 weeks

    Spirometry

  5. Peripheral muscle strength

    Time frame: 6 weeks

    Hand-held dynamometer

  6. Dyspnea

    Time frame: 6 weeks

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

  7. Depression

    Time frame: 6 weeks

    Montgomery Asberg Depression Rating Scale (MADRS))

  8. Quality of life

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Effects of Inspiratory Muscle Training in Patients With Sarcoidosis

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Oct 21, 2014
Registry last updated
Oct 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.