Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients

Not Applicable

Completed

• Conditions: Allogeneic Hematopoietic Stem Cell Transplantation
• Interventions: Device: Sham inspiratory muscle training; Device: Inspiratory muscle training

• Registration Number: NCT02270346
• Lead Sponsor: Gazi University

Brief Summary

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) causes various toxic effects in many body tissues, organs and systems such as immune, cardiovascular, pulmonary, gastrointestinal, neuroendocrine and musculoskeletal systems, liver, kidneys and skin.Available limited numbers of studies showed that inspiratory muscle weakness in allo-HSCT candidates and recipients. Although meta-analysis, systematic reviews and studies demonstrated beneficial effects of inspiratory muscle training on several outcomes in different disease groups; chronic obstructive pulmonary disease, bronchiectasis and heart failure, no published paper reported the effects of IMT in allo-HSC recipients.

Detailed Description

Thirty-eight allo-HSCT recipients (˃100 days past post-transplant status) were included. Before and after 6-week IMT, maximal and submaximal exercise capacity, respiratory and peripheral muscle strength, pulmonary functions, dyspnea and fatigue perception, depression and quality of life were evaluated. Primary outcome measurement was respiratory muscle strength, secondary outcomes were exercise capacity, dyspnea, peripheral muscle strength, quality of life, fatigue and depression.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-06
• Study Completion: 2013-09
• Status Verified: 2014-10
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-18
• Last Update Submitted: 2014-10-18
• Study First Posted: 2014-10-21
• Last Update Posted: 2014-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Allo-HSC recipients (˃100 days past post-transplant status),
• 18-65 years of age,
• Under standard medications

Exclusion Criteria

• Having cognitive disorder, orthopedic problem or neurological disease that were affecting functional capacity,
• Additional heart and lung diseases such as asthma, chronic obstructive pulmonary disease, acute infections or pneumonia,
• Problems prevented performing assessment and training such as visual problems and mucositis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Sham inspiratory muscle training	Sham: Control group received sham inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device .
Treatment group	Inspiratory muscle training	Intervention: Treatment group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device.

Primary Outcome Measures

Name	Time	Method
Inspiratory and expiratory muscle strength (MIP, MEP)	6 weeks	Mouth pressure device

Secondary Outcome Measures

Name	Time	Method
Dyspnea	6 weeks	Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales,
Peripheral muscle strength	6 weeks	Hand held dynamometer
Depression	6 weeks	Montgomery Asberg Depression Rating Scale (MADRS)
Submaximal exercise capacity	6 weeks	Six-minute walk test (6MWT)
Pulmonary function	6 weeks	Spirometry
Maximal exercise capacity	6 weeks	Modified incremental shuttle walk test (ISWT)
Fatigue	6 weeks	Fatigue Impact Scale (FIS)
Quality of life	6 weeks	European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C-30 version 3.0 (Turkish versions of all scales)