Effects of Different Inspiratory Muscle Training Protocols in Hematopoietic Stem Cell Transplant Recipients

Overview

Introduction: After haematopoietic stem cell transplantation (HSCT), patients often experience complications such as respiratory difficulties, fatigue and decreased quality of life. The aim of the study was to compare the effectiveness of different inspiratory muscle training (IMT) protocols on respiratory muscle strength and endurance, dyspnoea, maximal exercise capacity, diaphragmatic function, respiratory function parameters, peripheral muscle strength, fatigue, quality of life, oxidative stress parameters, muscle biomarkers and inflammatory biomarkers in HSCT recipients during the transplantation process. Method: The study will include patients between 18-65 years of age, who are able to walk and understand the instructions, who do not have orthopedic, neurological or cardiac disorders and who will undergo haematopoietic stem cell transplantation. Patients with cognitive impairments; orthopedic or neurological diseases that may affect the evaluation of physical fitness tests; patients with comorbidities such as asthma, COPD will not be included in the study. In cases where the exercise group subjects' attendance to the training protocol is interrupted for 3 sessions or more consecutively, the voluntariness to participate in the research is lost during the research process, and clinical haemodynamic instability develops in the subjects, the participant will be excluded from the study. Patients in whom exercise training is contraindicated such as acute bleeding, haemoglobin value \<5 g/dl, platelet count ≤10000 mm3, high fever (body temperature \>38◦C), severe pain, confusion, dizziness, nausea and vomiting will not be included in the exercise. It is planned as a prospective, randomised controlled and single blinded study. Triple blinding could not be performed due to the executive's evaluation and implementation of the study protocol. Patients included in the study will be randomly divided into 3 study groups of 15 people each. Stratified randomisation technique will be used. A total of 45 haematopoietic stem cell transplant patients will be included in the study. Patients will be evaluated 3 times: before exercise therapy (pre-HSCT), before and after starting the preparatory regime and after exercise therapy (post-HSCT). Primary assessment measures are dyspnoea, maximal exercise capacity, respiratory muscle strength and endurance, diaphragmatic respiration, oxidative stress parameters, inflammatory markers, muscle biomarkers, pulmonary function test. Secondary assessment measures were peripheral muscle strength, fatigue, depression, and quality of life. The research arms consisted of a total of 45(15;15;15) people in 3 groups: 'standard inspiratory muscle training group', 'functional respiratory muscle training group' and 'control group' with 15 people in each group. All patients in the control and research groups will receive inspiratory muscle training for a total of 30 minutes twice a day, every weekday during the transplantation period, starting at the end of the session in which their initial assessment was made. Functional respiratory muscle training group will perform functional exercises simultaneously with inspiratory muscle training 3 days a week (Monday-Wednesday-Friday or Tuesday-Thursday-Saturday). All exercises will be supervised by a physiotherapist. The most important originality of this study is that it is the first study to investigate the effects of functional respiratory muscle training on respiratory parameters, diaphragm function, peripheral muscle strength, maximum oxygen consumption, dyspnoea, fatigue, depression and quality of life in HSCT recipients. It is the first randomised controlled study to demonstrate the effect of inspiratory muscle training on diaphragmatic function in HSCT recipients and it is one of the rare studies in which exercise capacity will be evaluated by cardiopulmonary exercise test. It is also the first study to examine the relationship between inspiratory muscle training and muscle biomarkers and oxidative stress parameters in HSCT recipients. H0: There is no difference in the effectiveness of different inspiratory muscle training protocols on maximal exercise capacity, respiratory muscle strength, respiratory muscle endurance, diaphragmatic function, oxidative stress parameters, muscle biomarkers, inflammatory biomarkers, dyspnoea, peripheral muscle strength, quality of life, fatigue, depression in haematopoietic stem cell transplant recipients. H1: There is a difference in the effectiveness of different inspiratory muscle training protocols on maximal exercise capacity, respiratory muscle strength, respiratory muscle endurance, diaphragmatic function, oxidative stress parameters, muscle biomarkers, inflammatory biomarkers, dyspnoea, peripheral muscle strength, quality of life, fatigue, depression in haematopoietic stem cell transplant recipients.

Interventions

• Other Inspiratory Muscle Training
  Inspiratory muscle training will be performed at 40% of MIP workload, 1 set of 8-10 diaphragmatic respirations for 15 minutes, with 5-10 seconds rest intervals between sets. 5 days a week, 2 sessions per day.
• Other Functional Inspiratory Muscle Training
  This study investigates the integration of functional inspiratory muscle training (IMT) with conventional physiotherapy. Patients will perform inspiratory muscle training using the threshold loading technique with the POWERbreathe IMT device, combined with functional exercises. The functional IMT protocol will be administered face-to-face, 3 days a week, for 30 minutes per session over a 6-week period. Resistance on the IMT device will be set to 40% of the patient's maximal inspiratory pressure
• Other Sham Inspiratory Muscle Training
  Control group will be performed at 10% of the MIP workload, 1 set of 8-10 diaphragmatic breaths for 15 minutes, with 5-10 seconds rest intervals between sets. 2 sessions per day, 5 days a week.

Primary outcome measures

• Dyspnea Perception Measurement [Time frame: "Through study completion, an average of 1 year"]
• Cardiopulmonary Function Measurement [Time frame: "Through study completion, an average of 1 year"]
• Respiratory Muscle Strength Measurement [Time frame: "Through study completion, an average of 1 year"]
• Respiratory Muscle Endurance Measurement [Time frame: "Through study completion, an average of 1 year"]
• Diaphragm Function and Thickness Measurement [Time frame: "Through study completion, an average of 1 year"]
• Inflammatory Markers Measurement [Time frame: "Through study completion, an average of 1 year"]
• Oxidative Stress Parameters Measurement [Time frame: "Through study completion, an average of 1 year"]
• Muscle Biomarkers Measurement [Time frame: "Through study completion, an average of 1 year"]
• Pulmonary Function Test [Time frame: "Through study completion, an average of 1 year"]

Secondary outcome measures (4)

• Peripheral Muscle Strength Measurement [Time frame: "Through study completion, an average of 1 year"]
• Fatigue Perception Measurement [Time frame: "Through study completion, an average of 1 year"]
• Depression Measurement [Time frame: "Through study completion, an average of 1 year"]
• Quality of Life Measurement [Time frame: "Through study completion, an average of 1 year"]

Eligibility criteria

Inclusion criteria

• Planned haematopoietic stem cell transplantation in the adult bone marrow transplant unit
• Between the ages of 18-65
• Under standard medical treatment, including immunosuppressives, antibiotics and other medications
• Ability to walk, co-operate and be clinically stable
• No history of orthopaedic, neurological, cardiac disorders

Exclusion criteria

• Cognitive disorders
• Have orthopaedic or neurological diseases that may affect the assessment of physical fitness tests
• Having comorbidities such as asthma, COPD
• Conditions in which exercise training is contraindicated, such as acute bleeding, haemoglobin value <5 g/dl, platelet count ≤10000 mm3, high fever (body temperature >38◦C), severe pain, confusion, dizziness, nausea and vomiting
• Patients with pneumonia or any acute infection

-≥ 3 consecutive sessions of interruption of the exercise group subjects' attendance to the training protocol

• Loss of willingness to participate in the research during the research process
• Development of clinical haemodynamic instability in patients

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Istinye University — Istanbul

Identifiers

NCT: NCT07061444 · 24-207

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗