Allogeneic Hematopoietic Stem Cell Transplantation
Conditions
Keywords
Allogeneic HSCT, Inspiratory Muscle Training, Exercise Capacity
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.
Interventions
DEVICEInspiratory muscle training
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.
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.
Sponsors
Gazi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inspiratory and expiratory muscle strength (MIP, MEP) | 6 weeks | Mouth pressure device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary function | 6 weeks | Spirometry |
| Peripheral muscle strength | 6 weeks | Hand held dynamometer |
| Dyspnea | 6 weeks | Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales, |
| 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) |
| Submaximal exercise capacity | 6 weeks | Six-minute walk test (6MWT) |
| Maximal exercise capacity | 6 weeks | Modified incremental shuttle walk test (ISWT) |
| Depression | 6 weeks | Montgomery Asberg Depression Rating Scale (MADRS) |
Outcome results
None listed