Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients

• Sponsor: Gazi University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02270346
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Duration (Months): 18

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Allogeneic Hematopoietic Stem Cell Transplantation	Device: Inspiratory muscle training; Device: Sham inspiratory muscle training	N/A

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 Design

• Study Type: Interventional
• 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: Mar 1, 2012
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Inspiratory and expiratory muscle strength (MIP, MEP) [6 weeks]

   Mouth pressure device

Secondary Outcome Measures

1. Fatigue [6 weeks]

   Fatigue Impact Scale (FIS)

2. Pulmonary function [6 weeks]

   Spirometry

3. Peripheral muscle strength [6 weeks]

   Hand held dynamometer

4. Dyspnea [6 weeks]

   Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales,

5. Depression [6 weeks]

   Montgomery Asberg Depression Rating Scale (MADRS)

6. Quality of life [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 [6 weeks]

   Six-minute walk test (6MWT)

8. Maximal exercise capacity [6 weeks]

   Modified incremental shuttle walk test (ISWT)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Meral Boşnak Güçlü, Assoc. Prof., Gazi University
• ClinicalTrials.gov Identifier: NCT02270346
• Other Study ID Numbers: GaziUniversity
• First Posted: Oct 21, 2014
• Last Update Posted: Oct 21, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Meral Boşnak Güçlü, Assoc. Prof., Gazi University: Allogeneic HSCT, Inspiratory Muscle Training, Exercise Capacity
• Additional relevant MeSH terms: Respiratory Aspiration

Study Results

No Results Posted as of Oct 21, 2014