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NCT Number: NCT03625063

Effects of Pulmonary Rehabilitation in Hematopoietic Stem Cell Transplantation Recipients

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplantation Behavior Motor Activity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

Ankara, Çankaya, 06580, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients scheduled to undergo hematopoietic stem cell transplantation
  • under standard medications
  • 18-65 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

Treatment and study plan

Exercise training group

Other

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.

Control training group

Other

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.

Primary outcomes

  1. Maximal exercise capacity

    Time frame: Second day

    Maximal exercise capacity will be evaluated symptom limited cardiopulmonary exercise testing. Oxygen consumption will be measured by cardiopulmonary exercise test. The cardiopulmonary exercise test will be performed on the treadmill at a progressively increasing speed and grade.

Secondary outcomes

  1. Respiratory muscle strength

    Time frame: First day

    Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device .

  2. Respiratory muscle endurance

    Time frame: First day

    It will be evaluated incremental threshold loading test, in which participants started an initial load of 30% of maximal inspiratory pressure with a 10% increment every 2 minutes.

  3. Peripheral muscle strength

    Time frame: First day

    Shoulder abduction and knee extensor muscle strength using portable hand held dynamometer, hand grip strength using grip dynamometer will be evaluated.

  4. Pulmonary functions contains dynamic lung volumes

    Time frame: First day

    Pulmonary function tests will be performed using a spirometry according to the American Thoracic Society and European Respratory Society criteria.

    Forced expiratory volume in the first second (FEV1, (liter)) and (FEV1 (%)) , forced vital capacity (FVC (L)) and (FVC (%)), forced expiratory volume in the first second/forced vital capacity (FEV1/FVC (%)) , peak expiratory flow (PEF(L)), and (PEF (%)), and forced expiratory flow from 25 to 75 % (FEF25-75 %(L)), and (FEF25-75 % (%)) will be expressed as the liter and percentages of the predicted values.

  5. Physical activity

    Time frame: First day

    Physical activity will be evaluated multi sensor activity monitor for 4 consecutive days.

  6. Fatigue

    Time frame: First day

    Fatigue Severity Scale (Turkish version) - Fatigue Severity Scale (FSS) is a self-reported questionnaire. FSS evaluates patient's fatigue severity. This questionnaire includes 9 items and score range for each item from 1 to 7 point (7-point Likert scale). Fatigue Severity Scale score is calculates by deriving an arithmetic mean. Cut-scores of over 4 are indicative of significant fatigue (higher scores show more severe fatigue).

  7. Depression

    Time frame: Second day

    Beck Depression Inventory (Turkish version) - Beck Depression Inventory (BDI) is a self-reported questionnaire. BDI evaluates patients' depression level. This questionnaire includes 21 items. Each item scores from 0 to 3 point (higher scores shows patient ). The BAI scores are classified as "depression" over 17 points.

  8. Survival

    Time frame: 100th day and first year

    Kaplan-meier survival analysis will be calculated at 100th day and first year.

  9. Functional exercise capacity

    Time frame: First day

    Functional exercise capacity will be evaluated with 6-minute walking test according to the ATS and ERS criteria.

  10. Disease Specific Quality of Life

    Time frame: First day

    Quality of life was measured using Turkish version of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version 3.0 (EORTCQLQ) which is widely used as health related quality of life questionnaire in cancer patients. The cancer-specific questionnaire has 30 questions and incorporates five functional scales, three symptom scales, a global health status and several single items. All item scores are transformed to 0-100. Higher values indicate higher functional/healthy level in functional scales, a higher quality of life level in global health status and increased symptoms in symptom scales.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Investigation of Pulmonary Rehabilitation on Exercise Capacity, Physical Activity Level, Respiratory Muscle Strength and Endurance During Transplantation Process in Hematopoietic Stem Cell Transplantation Recipients

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 10, 2018
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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