Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
Primary Purpose
Allogeneic Hematopoietic Stem Cell Transplantation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inspiratory muscle training
Sham inspiratory muscle training
Sponsored by
About this trial
This is an interventional supportive care trial for Allogeneic Hematopoietic Stem Cell Transplantation focused on measuring Allogeneic HSCT, Inspiratory Muscle Training, Exercise Capacity
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Treatment group
Control group
Arm Description
Intervention: Treatment group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device.
Sham: Control group received sham inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device .
Outcomes
Primary Outcome Measures
Inspiratory and expiratory muscle strength (MIP, MEP)
Mouth pressure device
Secondary Outcome Measures
Fatigue
Fatigue Impact Scale (FIS)
Pulmonary function
Spirometry
Peripheral muscle strength
Hand held dynamometer
Dyspnea
Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales,
Depression
Montgomery Asberg Depression Rating Scale (MADRS)
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)
Submaximal exercise capacity
Six-minute walk test (6MWT)
Maximal exercise capacity
Modified incremental shuttle walk test (ISWT)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02270346
Brief Title
Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
Official Title
Effects of Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allogeneic Hematopoietic Stem Cell Transplantation
Keywords
Allogeneic HSCT, Inspiratory Muscle Training, Exercise Capacity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
Intervention: Treatment group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Sham: Control group received sham inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device .
Intervention Type
Device
Intervention Name(s)
Inspiratory muscle training
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham inspiratory muscle training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inspiratory and expiratory muscle strength (MIP, MEP)
Description
Mouth pressure device
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Fatigue
Description
Fatigue Impact Scale (FIS)
Time Frame
6 weeks
Title
Pulmonary function
Description
Spirometry
Time Frame
6 weeks
Title
Peripheral muscle strength
Description
Hand held dynamometer
Time Frame
6 weeks
Title
Dyspnea
Description
Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales,
Time Frame
6 weeks
Title
Depression
Description
Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame
6 weeks
Title
Quality of life
Description
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C-30 version 3.0 (Turkish versions of all scales)
Time Frame
6 weeks
Title
Submaximal exercise capacity
Description
Six-minute walk test (6MWT)
Time Frame
6 weeks
Title
Maximal exercise capacity
Description
Modified incremental shuttle walk test (ISWT)
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülşah Barğı, MSc.
Organizational Affiliation
Gazi University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Meral Boşnak Güçlü, PhD.
Organizational Affiliation
Gazi University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zeynep Arıbaş, MSc.
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zeynep Şahika Akı, MD, PhD.
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gülsan Türköz Sucak, MD, PhD.
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
9128987
Citation
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.
Results Reference
result
PubMed Identifier
1611601
Citation
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.
Results Reference
result
PubMed Identifier
16002928
Citation
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.
Results Reference
result
PubMed Identifier
18264142
Citation
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.
Results Reference
result
PubMed Identifier
26135532
Citation
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.
Results Reference
derived
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Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
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