- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02270346
Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
Effects of Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment group
Intervention: Treatment group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device.
|
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 Comparator: Control group
Sham: Control group received sham inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device .
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inspiratory and expiratory muscle strength (MIP, MEP)
Time Frame: 6 weeks
|
Mouth pressure device
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peripheral muscle strength
Time Frame: 6 weeks
|
Hand held dynamometer
|
6 weeks
|
Fatigue
Time Frame: 6 weeks
|
Fatigue Impact Scale (FIS)
|
6 weeks
|
Pulmonary function
Time Frame: 6 weeks
|
Spirometry
|
6 weeks
|
Dyspnea
Time Frame: 6 weeks
|
Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales,
|
6 weeks
|
Depression
Time Frame: 6 weeks
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
6 weeks
|
Quality of life
Time Frame: 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)
|
6 weeks
|
Submaximal exercise capacity
Time Frame: 6 weeks
|
Six-minute walk test (6MWT)
|
6 weeks
|
Maximal exercise capacity
Time Frame: 6 weeks
|
Modified incremental shuttle walk test (ISWT)
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Meral Boşnak Güçlü, PhD., Gazi University
- Study Chair: Gülşah Barğı, MSc., Gazi University
- Principal Investigator: Zeynep Arıbaş, MSc., Gazi University
- Principal Investigator: Zeynep Şahika Akı, MD, PhD., Gazi University
- Principal Investigator: Gülsan Türköz Sucak, MD, PhD., Gazi University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GaziUniversity
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