- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03625063
Effects of Pulmonary Rehabilitation in Hematopoietic Stem Cell Transplantation Recipients
Investigation of Pulmonary Rehabilitation on Exercise Capacity, Physical Activity Level, Respiratory Muscle Strength and Endurance During Transplantation Process 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Çankaya
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Ankara, Çankaya, Turkey, 06580
- Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Exercise training group
Inspiratory muscle, upper extremity aerobic exercise and progressive resistance trainings
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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.
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Sham Comparator: Control training group
Upper extremity aerobic exercise and progressive resistance trainings
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal exercise capacity
Time Frame: Second day
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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.
|
Second day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory muscle strength
Time Frame: First day
|
Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device .
|
First day
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Respiratory muscle endurance
Time Frame: First day
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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.
|
First day
|
Peripheral muscle strength
Time Frame: First day
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Shoulder abduction and knee extensor muscle strength using portable hand held dynamometer, hand grip strength using grip dynamometer will be evaluated.
|
First day
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Pulmonary functions contains dynamic lung volumes
Time Frame: First day
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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. |
First day
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Physical activity
Time Frame: First day
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Physical activity will be evaluated multi sensor activity monitor for 4 consecutive days.
|
First day
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Fatigue
Time Frame: First day
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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).
|
First day
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Depression
Time Frame: Second day
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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.
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Second day
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Survival
Time Frame: 100th day and first year
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Kaplan-meier survival analysis will be calculated at 100th day and first year.
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100th day and first year
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Functional exercise capacity
Time Frame: First day
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Functional exercise capacity will be evaluated with 6-minute walking test according to the ATS and ERS criteria.
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First day
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Disease Specific Quality of Life
Time Frame: First day
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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.
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First day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zeliha Çelik, MSc, Gazi University
- Study Chair: Selin Bayram, MSc, Gazi University
- Study Director: Meral Boşnak Güçlü, Assoc. Prof, Gazi University
- Principal Investigator: Gülşah Barğı, PhD, Gazi University
Publications and helpful links
General Publications
- Kelsey CR, Scott JM, Lane A, Schwitzer E, West MJ, Thomas S, Herndon JE 2nd, Michalski MG, Horwitz ME, Hennig T, Jones LW. Cardiopulmonary exercise testing prior to myeloablative allo-SCT: a feasibility study. Bone Marrow Transplant. 2014 Oct;49(10):1330-6. doi: 10.1038/bmt.2014.159. Epub 2014 Jul 28.
- Morishita S, Kaida K, Yamauchi S, Wakasugi T, Ikegame K, Ogawa H, Domen K. Relationship of physical activity with physical function and health-related quality of life in patients having undergone allogeneic haematopoietic stem-cell transplantation. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12669. Epub 2017 Feb 21.
- Kovalszki A, Schumaker GL, Klein A, Terrin N, White AC. Reduced respiratory and skeletal muscle strength in survivors of sibling or unrelated donor hematopoietic stem cell transplantation. Bone Marrow Transplant. 2008 Jun;41(11):965-9. doi: 10.1038/bmt.2008.15. Epub 2008 Feb 11.
- Mello M, Tanaka C, Dulley FL. Effects of an exercise program on muscle performance in patients undergoing allogeneic bone marrow transplantation. Bone Marrow Transplant. 2003 Oct;32(7):723-8. doi: 10.1038/sj.bmt.1704227.
- Hacker ED, Larson J, Kujath A, Peace D, Rondelli D, Gaston L. Strength training following hematopoietic stem cell transplantation. Cancer Nurs. 2011 May-Jun;34(3):238-49. doi: 10.1097/NCC.0b013e3181fb3686.
- Baumann FT, Zopf EM, Nykamp E, Kraut L, Schule K, Elter T, Fauser AA, Bloch W. Physical activity for patients undergoing an allogeneic hematopoietic stem cell transplantation: benefits of a moderate exercise intervention. Eur J Haematol. 2011 Aug;87(2):148-56. doi: 10.1111/j.1600-0609.2011.01640.x.
- Bargi G, Guclu MB, Aribas Z, Aki SZ, Sucak GT. Inspiratory muscle training in allogeneic hematopoietic stem cell transplantation recipients: a randomized controlled trial. Support Care Cancer. 2016 Feb;24(2):647-659. doi: 10.1007/s00520-015-2825-3. Epub 2015 Jul 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Gazi University 8
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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