Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
NCT ID: NCT02270346
Last Updated: 2014-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2012-03-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Treatment group
Intervention: Treatment group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device.
Inspiratory 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
Sham: Control group received sham inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device .
Sham inspiratory muscle training
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.
Interventions
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Inspiratory 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.
Sham inspiratory muscle training
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.
Eligibility Criteria
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Inclusion Criteria
* 18-65 years of age,
* Under standard medications
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Gazi University
OTHER
Responsible Party
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Meral Boşnak Güçlü
Assoc. Prof.
Principal Investigators
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Gülşah Barğı, MSc.
Role: STUDY_CHAIR
Gazi University
Meral Boşnak Güçlü, PhD.
Role: STUDY_DIRECTOR
Gazi University
Zeynep Arıbaş, MSc.
Role: PRINCIPAL_INVESTIGATOR
Gazi University
Zeynep Şahika Akı, MD, PhD.
Role: PRINCIPAL_INVESTIGATOR
Gazi University
Gülsan Türköz Sucak, MD, PhD.
Role: PRINCIPAL_INVESTIGATOR
Gazi University
References
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Dimeo FC, Tilmann MH, Bertz H, Kanz L, Mertelsmann R, Keul J. Aerobic exercise in the rehabilitation of cancer patients after high dose chemotherapy and autologous peripheral stem cell transplantation. Cancer. 1997 May 1;79(9):1717-22.
Ferrell B, Grant M, Schmidt GM, Rhiner M, Whitehead C, Fonbuena P, Forman SJ. The meaning of quality of life for bone marrow transplant survivors. Part 1. The impact of bone marrow transplant on quality of life. Cancer Nurs. 1992 Jun;15(3):153-60.
White AC, Terrin N, Miller KB, Ryan HF. Impaired respiratory and skeletal muscle strength in patients prior to hematopoietic stem-cell transplantation. Chest. 2005 Jul;128(1):145-52. doi: 10.1378/chest.128.1.145.
Kovalszki A, Schumaker GL, Klein A, Terrin N, White AC. Reduced respiratory and skeletal muscle strength in survivors of sibling or unrelated donor hematopoietic stem cell transplantation. Bone Marrow Transplant. 2008 Jun;41(11):965-9. doi: 10.1038/bmt.2008.15. Epub 2008 Feb 11.
Bargi G, Guclu MB, Aribas Z, Aki SZ, Sucak GT. Inspiratory muscle training in allogeneic hematopoietic stem cell transplantation recipients: a randomized controlled trial. Support Care Cancer. 2016 Feb;24(2):647-659. doi: 10.1007/s00520-015-2825-3. Epub 2015 Jul 2.
Other Identifiers
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GaziUniversity
Identifier Type: -
Identifier Source: org_study_id
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