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Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients

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ClinicalTrials.gov Identifier: NCT02270346
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : October 21, 2014
Sponsor:
Information provided by (Responsible Party):
Meral Boşnak Güçlü, Gazi University

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.

Condition or disease Intervention/treatment Phase
Allogeneic Hematopoietic Stem Cell Transplantation Device: Inspiratory muscle training Device: Sham inspiratory muscle training Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
Study Start Date : March 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
Active Comparator: Treatment group
Intervention: Treatment group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device.
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.


Sham Comparator: Control group
Sham: Control group received sham inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device .
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.





Primary Outcome Measures :
  1. Inspiratory and expiratory muscle strength (MIP, MEP) [ Time Frame: 6 weeks ]
    Mouth pressure device


Secondary Outcome Measures :
  1. Fatigue [ Time Frame: 6 weeks ]
    Fatigue Impact Scale (FIS)

  2. Pulmonary function [ Time Frame: 6 weeks ]
    Spirometry

  3. Peripheral muscle strength [ Time Frame: 6 weeks ]
    Hand held dynamometer

  4. Dyspnea [ Time Frame: 6 weeks ]
    Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales,

  5. Depression [ Time Frame: 6 weeks ]
    Montgomery Asberg Depression Rating Scale (MADRS)

  6. 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)

  7. Submaximal exercise capacity [ Time Frame: 6 weeks ]
    Six-minute walk test (6MWT)

  8. Maximal exercise capacity [ Time Frame: 6 weeks ]
    Modified incremental shuttle walk test (ISWT)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270346


Sponsors and Collaborators
Gazi University
Investigators
Study Chair: Gülşah Barğı, MSc. Gazi University
Study Director: Meral Boşnak Güçlü, PhD. 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 of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Meral Boşnak Güçlü, Assoc. Prof., Gazi University
ClinicalTrials.gov Identifier: NCT02270346     History of Changes
Other Study ID Numbers: GaziUniversity
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: October 21, 2014
Last Verified: October 2014

Keywords provided by Meral Boşnak Güçlü, Gazi University:
Allogeneic HSCT, Inspiratory Muscle Training, Exercise Capacity

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes