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

Summary

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.

Conditions

• Hematopoietic Stem Cell Transplantation (HSCT)
• Pulmonary Rehabilitation
• Inspiratory Muscle Training

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 (MIP) and adjusted weekly based on measured MIP values. Exercises will be categorized into three progressive difficulty levels (easy, medium, and hard), with each stage lasting 2 weeks. Patients will inhale through the POWERbreathe IMT device during exercise movements and exhale during the return phase, ensuring simultaneous respiratory muscle activation and functional training.

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.

Sponsors & Collaborators

• Ceren Derya Gültekin

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-02

Primary Completion

2026-08-02

Completion

2026-09-02

Countries

• Turkey (Türkiye)

Study Locations