Actively Recruiting
Effects of Different Inspiratory Muscle Training Protocols in Hematopoietic Stem Cell Transplant Recipients
Led by Ceren Derya Gültekin · Updated on 2025-07-11
45
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how different inspiratory muscle training (IMT) methods affect patients undergoing hematopoietic stem cell transplantation (HSCT). This study focuses on improving respiratory muscle strength and endurance, reducing breathlessness, and enhancing exercise capacity and quality of life. It also examines diaphragm function, muscle strength, fatigue, oxidative stress, and inflammatory and muscle biomarkers in these patients. The trial is a prospective, randomized controlled, and single-blinded study designed to compare the effects of various IMT protocols during the transplantation process. Participants will be divided into three groups: one receiving standard inspiratory muscle training using the PowerBreathe Classic device at 40% of their maximum inspiratory pressure (MIP), a functional inspiratory muscle training group combining IMT with functional exercises three times a week, and a control group performing sham IMT at 10% MIP. All groups will train twice daily, five days a week, during the transplantation period, with functional group exercises supervised by a physiotherapist. Vital signs and other safety parameters will be monitored throughout the training sessions. Patients will be assessed three times: before exercise therapy, before and after starting the preparatory regime, and after exercise therapy post-transplant. Evaluations include breathlessness perception, cardiopulmonary function, respiratory muscle strength and endurance, diaphragm function, inflammatory and oxidative stress markers, muscle biomarkers, pulmonary function tests, peripheral muscle strength, fatigue, depression, and quality of life. The study will continue for about one year, with close monitoring of physical and biochemical outcomes to determine the impact of different inspiratory muscle training protocols on transplant recipients.
CONDITIONS
Brief Title
Effects of Different Inspiratory Muscle Training Protocols in Hematopoietic Stem Cell Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Cognitive disorders
- Orthopaedic or neurological diseases that may affect the assessment of physical fitness tests
- Comorbidities such as asthma, COPD
- Conditions contraindicating exercise training such as acute bleeding, haemoglobin value <5 g/dl, platelet count 30000 mm3, high fever (body temperature >38C), severe pain, confusion, dizziness, nausea and vomiting
- Patients with pneumonia or any acute infection
- Missing 3 or more consecutive exercise sessions
- Loss of willingness to participate during the research
- Development of clinical haemodynamic instability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants perform inspiratory muscle training at 40% of their maximal inspiratory pressure (MIP) workload. Training consists of 1 set of 8-10 diaphragmatic breaths for 15 minutes with 5-10 seconds rest intervals between sets, conducted twice daily, five days a week. MIP is reassessed weekly to adjust the training workload. Vital signs are monitored throughout sessions.
Multiple training sessions: twice daily, 5 days a week
Duration - 6 weeks
Participants engage in functional inspiratory muscle training combining the POWERbreathe IMT device with progressive functional exercises. This face-to-face training occurs three times per week for 30 minutes per session over 6 weeks. Resistance is set at 40% of MIP and adjusted weekly. Exercises progress through easy, medium, and hard levels every two weeks. Vital signs and symptoms are monitored before, during, and after sessions.
3 supervised sessions per week plus additional unsupervised IMT on other days
Duration - 6 weeks
Participants in the control group perform sham inspiratory muscle training at 10% of MIP workload, with 1 set of 8-10 diaphragmatic breaths for 15 minutes, twice daily, five days a week. Vital signs are measured before, during, and after exercises with continuous monitoring during sessions.
Multiple training sessions: twice daily, 5 days a week
Duration - Up to 1 year
Participants are monitored for outcomes including dyspnea perception, cardiopulmonary function, respiratory muscle strength and endurance, diaphragm function, inflammatory and oxidative stress markers, muscle biomarkers, pulmonary function, peripheral muscle strength, fatigue, depression, and quality of life for up to one year after training completion.
Periodic visits for assessments during study completion
Trial Site Locations
Total: 1 location
1
Istinye University
Istanbul, Zeytinburnu, Turkey (Türkiye), 34010
Actively Recruiting
Research Team
C
Ceren Derya Gültekin, MSc
M
Mine Gülden Polat, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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