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Completed

NCT Number: NCT02270346

Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory muscle training

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 Inspiratory Muscle Training

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.

Primary outcomes

  1. Inspiratory and expiratory muscle strength (MIP, MEP)

    Time frame: 6 weeks

    Mouth pressure device

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Effects of Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 21, 2014
Registry last updated
Oct 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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