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

Ceren Derya Gültekin

Status: Enrolling

Conditions: Inspiratory Muscle Training; Pulmonary Rehabilitation; Hematopoietic Stem Cell Transplantation (HSCT)

Treatments: Other: Sham Inspiratory Muscle Training; Other: Functional Inspiratory Muscle Training; Other: Inspiratory Muscle Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07061444

24-207

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

45 participants in 3 patient groups, including a placebo group

1. Inspiratory Muscle Training Group

Active Comparator group

Description:

Fifteen patients meeting the inclusion criteria will undergo standard inspiratory muscle training using the PowerBreathe Classic device (HaB International Ltd., Southam, UK). IMT will be performed at 40% of the maximum inspiratory pressure (MIP), with weekly re-assessment of MIP by the responsible researcher to adjust the training workload. Each session will consist of 8-10 diaphragmatic breaths, followed by a rest interval of 5-10 seconds, lasting 15 minutes per session. Training will be conducted twice daily, five days per week. Vital signs, including heart rate and oxygen saturation, will be monitored continuously throughout the exercises, and measurements will also be taken before, after, and during the first minute of recovery. This progressive IMT protocol aims to optimize inspiratory muscle strength through evidence-based threshold pressure loading, ensuring patient safety and effective respiratory muscle adaptation over time.

Treatment:

Other: Inspiratory Muscle Training

2. Functional Inspiratory Muscle Training Group

Active Comparator group

Description:

Fifteen patients will undergo functional respiratory muscle training integrating inspiratory muscle training (IMT) and functional exercises. The POWERbreathe IMT device, using a threshold loading technique, will be set at 40% of maximum inspiratory pressure (MIP) and adjusted weekly based on updated MIP values. Training sessions will be conducted face-to-face, three times per week, for 30 minutes under physiotherapist supervision, while classical IMT will continue on other days. During each session, heart rate, oxygen saturation, fatigue, and dyspnoea perception will be monitored before, during, and after exercises, including the first minute of recovery. The six-week program will involve progressive functional exercises classified into three difficulty levels-easy, medium, and hard-spanning two-week intervals. Patients will be instructed to inhale through the POWERbreathe device during movement and exhale upon returning to the starting position.

Treatment:

Other: Functional Inspiratory Muscle Training

3. Control Group

Placebo Comparator group

Description:

Sham protocol will be applied to 15 randomly selected patients. All vital signs of the patient will be taken before and after exercise training and during the 1st minute recovery period. Oxygen saturation monitoring and heart rate will be measured throughout the exercise. Type: threshold loading inspiratory muscle training (PowerBreath classic will be used.) Progression: will be studied at 10% of the re-measured MIP at the beginning of each week.

Treatment:

Other: Sham Inspiratory Muscle Training