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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
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 14, 2014
    Last Updated
    October 18, 2014
    Sponsor
    Gazi University
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    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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