Inspiratory Muscle Training in Sarcoidosis

NCT02270333 | Completed

• 1 other identifier: GaziU
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sarcoidosis

Keywords

sarcoidosis; inspiratory muscle strength; exercise capacity; quality of life

Outcome Measures

Primary Outcomes (1)

• Maximum inspiratory and expiratory muscle strength (MIP, MEP)

  Mouth pressure device

  6 weeks

Secondary Outcomes (8)

• Exercise Capacity

  6 weeks

• Maximal Exercise Capacity

  6 weeks

• Fatigue

  6 weeks

• Pulmonary function and diffusing capacity

  6 weeks

• Peripheral muscle strength

  6 weeks

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

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

Device: Inspiratory muscle training

Control group

SHAM COMPARATOR

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

Device: Sham inspiratory muscle training

Interventions

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.

Treatment group

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.

Control group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gazi University: lead

Related Publications (5)

• 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.

  PMID: 15618580 RESULT

• 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.

  PMID: 17099029 RESULT

• 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.

  PMID: 11451823 RESULT

• 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.

  PMID: 9230229 RESULT

• 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.

  PMID: 26715771 DERIVED

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Müşerrefe Nur Karadallı, MSc.

  Gazi University

  STUDY CHAIR

• Burcu Camcıoğlu, MSc.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Meral Boşnak Güçlü, PhD

  Gazi University

  STUDY DIRECTOR

• Nurdan Köktürk, MD

  Gazi University

  PRINCIPAL INVESTIGATOR

• Haluk Türktaş, MD

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 21, 2014
• Study Start: April 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: April 1, 2014
• Last Updated: October 21, 2014

Record last verified: 2014-10