Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients

October 18, 2014 updated by: Meral Boşnak Güçlü, Gazi University

Effects of 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.

Study Overview

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

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

October 14, 2014

First Submitted That Met QC Criteria

October 18, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Estimate)

October 21, 2014

Last Update Submitted That Met QC Criteria

October 18, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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