Clinical trial NCT03625063: Effects of Pulmonary Rehabilitation in Hematopoietic Stem Cell Transplantation Recipients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Keywords: exercise capacity
physical activity
respiratory muscle strength
respiratory muscle endurance
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximal exercise capacity
timeFrame: Second day
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: First day
measure: Respiratory muscle endurance
timeFrame: First day
measure: Peripheral muscle strength
timeFrame: First day
measure: Pulmonary functions contains dynamic lung volumes
timeFrame: First day
measure: Physical activity
timeFrame: First day
measure: Fatigue
timeFrame: First day
measure: Depression
timeFrame: Second day
measure: Survival
timeFrame: 100th day and first year
measure: Functional exercise capacity
timeFrame: First day
measure: Disease Specific Quality of Life
timeFrame: First day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
state: Çankaya
Study officials:
affiliation: Gazi University
name: Selin Bayram, MSc
role: STUDY_CHAIR
affiliation: Gazi University
name: Meral Boşnak Güçlü, Assoc. Prof
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Gülşah Barğı, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Zeliha Çelik, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.