Effects of Pulmonary Rehabilitation in Hematopoietic Stem Cell Transplantation Recipients

  • STATUS
    Recruiting
  • End date
    Dec 25, 2021
  • participants needed
    20
  • sponsor
    Gazi University
Updated on 25 January 2021
graft versus host disease
immunosuppression
fibrosis
allogeneic hematopoietic stem cell transplant
hereditary diseases

Summary

Stem cell transplantation is a process in which stem cells are harvested from either a patient's or donor's bone morrow or peripheral blood for intravenous infusion. Hematopoietic stem cell transplantation is a treatment with a high curative potential that may benefit a great number of patients with hematological, oncological, immunologic and hereditary diseases. In contrast, there are significant risks of chronic and acute complications due to conditioning regimens and immunosuppression, toxicity infections, graft versus host disease (GVHD) and inactivity including being bedridden. Patients undergoing hematopoietic stem cell transplantation are exposed to risk factors due to chemotherapy, whole body radiation, high dose corticosteroids, treatment-related inactivity, transplantation and GVHD-related muscle damage. Direct toxicity of the cardiovascular and musculoskeletal system (left ventricular dysfunction, pulmonary fibrosis) in relation to hematopoietic stem cell transplantation and secondary indirect physiological consequences of treatment such as exercise intolerance, sarcopenia are seen.

In literature, there are few studies showing that aerobic exercise and resistance training applied during and after the transplantation process has positive effects on muscle strength and endurance, fatigue, functional performance, quality of life and physical activity. It has been shown in the literature that inspiratory muscle training in allogeneic hematopoietic stem cell transplant recipients increases functional exercise capacity, inspiratory and expiratory muscle strength, and reduces effort dyspnea perception, but the effects of inspiratory muscle training during transplantation have not been investigated. There are no studies showing long-term follow-up of comprehensive cardiopulmonary rehabilitation program during hematopoietic stem cell transplantation and which of these outcome measures are survival effect. Therefore, the investigators aimed to investigate the effect of cardiopulmonary rehabilitation on hematopoietic stem cell transplantation in terms of exercise capacity, respiratory and peripheral muscle strength, respiratory muscle endurance, respiratory function, physical activity level, fatigue, depression and quality of life effects and the effect of these outcome measures on survival.

Description

According to sample size calculation 20 patients scheduled for hematopoietic stem cell transplantation will be included. Patients scheduled for hematopoietic stem cell transplantation will be evaluated four times; pre-transplantation, post-transplantation, 100th day after transplantation and 1st year after transplantation. Recipients will be randomized into study and control groups. Cardiopulmonary rehabilitation programme includes inspiratory muscle training, upper extremity aerobic exercise, progressive resistance training will be performed study groups. Upper extremity aerobic exercise and progressive resistance training will be performed control groups. Exercise capacity, physical activity, pulmonary functions, respiratory and peripheral muscle strength, respiratory muscle endurance, dyspnea and fatigue perception, depression and quality of life will be evaluated. Primary outcome measurements are exercise capacity and which outcome measures influence survival. Secondary outcomes are respiratory and peripheral muscle strength, respiratory muscle endurance, pulmonary functions, physical activity, dyspnea and fatigue perception, depression and quality of life.

Details
Condition Stem Cell Transplantation, Hematopoietic Stem Cell Transplantation, HSCT, Hematopoietic Stem Cell Transplant, Stem Cell Transplant
Treatment Exercise training group, Control training group
Clinical Study IdentifierNCT03625063
SponsorGazi University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have Hematopoietic Stem Cell Transplantation?
Do you have any of these conditions: Hematopoietic Stem Cell Transplantation or Hematopoietic Stem Cell Transplant or Stem Cell Transplantation or HSCT or Stem Cell Transplant?
patients scheduled to undergo hematopoietic stem cell transplantation
under standard medications
-65 years of age

Exclusion Criteria

orthopedic or neurological disease with a potential to affect functional capacity
comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute infections or pneumonia
have problems that can prevent evaluation
take treatment other than standard medications during transplantation
having acute hemorrhage in the intracranial and / or lung and other areas
having any contraindication to exercise training
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