Effects of Pulmonary Rehabilitation in Hematopoietic Stem Cell Transplantation Recipients
Condition: Hematopoietic Stem Cell Transplantation
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Exercise training group; Control training group
Intervention type(s): Other; Other
Intervention description(s): All exercise program will be applied during supervised session by a physiotherapist. Range of maximal heart rate will be screened by heart rate monitor during supervised session each day at patient's room. Inspiratory muscle training (threshold loading device (Threshold®- Inspiratory Muscle Trainer) at 20-30% of maximal inspiratory pressure (MIP)), upper extremity aerobic exercise training (arm ergometer, at 60-80% of maximum heart rate, dyspnea perception at 3-4 level as well as fatigue perception at 5-6 level according to Modified Borg Scale) and progressive resistance training (shoulder flexors, shoulder abduction and knee extensors at 4-6 level according to modified Borg scale) will be performed in the treatment group during acute hematopoietic stem cell transplantation process.; All exercise program will be applied during supervised session by a physiotherapist. Range of maximal heart rate will be screened by heart rate monitor during supervised session each day in patient's room.Upper extremity aerobic exercise training (arm ergometer, at 60-80% of maximum heart rate, dyspnea perception at 3-4 level as well as fatigue perception at 5-6 level according to Modified Borg Scale) and progressive resistance training (shoulder flexors, shoulder abduction and knee extensors at 4-6 level according to modified Borg scale) except inspiratory muscle training will be performed in the control group during acute hematopoietic stem cell transplantation process.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Keywords: exercise capacity; physical activity; respiratory muscle strength; respiratory muscle endurance