Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients

Conditions
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Allogeneic Hematopoietic Stem Cell Transplantation

Intervention / Treatment
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* Device: Inspiratory muscle training
* Device: Sham inspiratory muscle training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>Intervention: Treatment group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device. | Device: Inspiratory muscle training<br>* Treatment group received inspiratory muscle training 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.<br>|
| Sham Comparator: Control group<br>Sham: Control group received sham inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device . | Device: Sham inspiratory muscle training<br>* Control group received sham inspiratory muscle training using threshold loading device (POWERbreathe Classic IMT Technologies Ltd. Birmingham, England) at fixed workload, 5% of MIP. 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inspiratory and expiratory muscle strength (MIP, MEP) | Mouth pressure device | 6 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allogeneic HSCT, Inspiratory Muscle Training, Exercise Capacity