Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients

Gazi University40 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Interventions

Inspiratory muscle trainingDEVICE

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 trainingDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Inspiratory and expiratory muscle strength (MIP, MEP)

Mouth pressure device

Time frame: 6 weeks

Secondary Outcomes

Fatigue

Fatigue Impact Scale (FIS)

Time frame: 6 weeks

Pulmonary function

Spirometry

Time frame: 6 weeks

Peripheral muscle strength

Hand held dynamometer

Time frame: 6 weeks

Dyspnea

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

Time frame: 6 weeks

Depression

Montgomery Asberg Depression Rating Scale (MADRS)

Time frame: 6 weeks

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)

Time frame: 6 weeks

Submaximal exercise capacity

Six-minute walk test (6MWT)

Time frame: 6 weeks

Maximal exercise capacity

Modified incremental shuttle walk test (ISWT)

Time frame: 6 weeks