NCT03448627|Completed
Physical Impairments in Allogeneic-HSCT
Physiological Responses to Maximal Exercise Capacity and Muscle Strength in Survived Hematopoietic Stem Cell Transplantation Recipients
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Physiological Responses to Maximal Exercise Capacity and Muscle Strength in Survived Hematopoietic Stem Cell Transplantation Recipients
Sponsor study identifier
observational
122
1 country
1
Study Start
March 2012
Actual (reported)Primary Completion
November 2014
Actual (reported)Study Completion
December 2017
Actual (reported)Pulmonary functions, exercise capacity and muscle strength deteriorate in survived hematopoietic stem cell transplantation (HSCT) recipients due to toxic effects of chemotherapy, radiotherapy, conditioning regimens and/or corticosteroid use before HSCT, prolonged stay of recipients in rooms with laminar airflow and strict infection control rules during process of HSCT. There are also limited numbers of studies demonstrated pulmonary function abnormalities, decreased maximal exercise capacity, respiratory and peripheral muscle weakness in recipients. Current study was planned since no study compared pulmonary functions, maximal exercise capacity, respiratory and peripheral muscle strength between recipients and healthy individuals in the literature.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2012
Actual (reported)November 2014
Actual (reported)December 2017
Actual (reported)February 22, 2018
Actual (reported)February 28, 2018
Actual (reported)Modified-Incremental Shuttle Walk Test (ISWT)
This test was used to evaluate maximal exercise capacity
15-20 minutes
pulmonary function test
5 minutes
inspiratory and expiratory muscle strength (MIP, MEP)
5-10 minutes
Quadriceps femoris muscle strength
5 minutes
Pulmonary functions \[spirometry\], maximal exercise capacity \[Modified-Incremental Shuttle Walk Test (ISWT)\], inspiratory and expiratory muscle strength (MIP and MEP, respectively) \[mouth pressure device\] and peripheral muscle strength \[hand-held dynamometer\] were evaluated in allogeneic HSCT recipients (n=66).Vital signs, dyspnea and fatigue perception \[Modified Borg Scale\] were recorded as pre-post measurements of Modified-ISWT.
Healthy individuals (n=50) were selected from individuals without known and diagnosed any chronic diseases. Similar measurements were applicated in healthy individuals.
66 recipients underwent allogeneic HSCT who were at minimum 100 days status post-transplantation compared with 50 healthy individuals. All recipients transplanted at the Bone Marrow Transplantation Unit of University Faculty of Medicine. All measurements were done by a physiotherapist at Cardiopulmonary Unit of University Faculty of Health Science Department of Physiotherapy and Rehabilitation. Demographic and clinical characteristics of all participants were recorded. Study was planned as retrospective, cross sectional and approved by the local Ethics Committee. Informed consent was obtained from all individual participants included in the study.
Gazi University Faculty of Health Science Department of PhysioTherapy
Ankara, 06010, Turkey (Türkiye)
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.
Morishita S, Kaida K, Yamauchi S, Sota K, Ishii S, Ikegame K, Kodama N, Ogawa H, Domen K. Relationship between corticosteroid dose and declines in physical function among allogeneic hematopoietic stem cell transplantation patients. Support Care Cancer. 2013 Aug;21(8):2161-9. doi: 10.1007/s00520-013-1778-7. Epub 2013 Mar 9.
Gülşah Barğı, PhD
Gazi University
Meral Boşnak Güçlü, PhD
Gazi University
Gülsan Türköz Sucak
Bahçeşehir University
122 participants (actual enrollment reported by the registry).
First Submitted
February 22, 2018
First Posted
February 28, 2018
Study Start
March 2012
Actual (reported)Contact the study team to confirm eligibility.
Knols RH, de Bruin ED, Uebelhart D, Aufdemkampe G, Schanz U, Stenner-Liewen F, Hitz F, Taverna C, Aaronson NK. Effects of an outpatient physical exercise program on hematopoietic stem-cell transplantation recipients: a randomized clinical trial. Bone Marrow Transplant. 2011 Sep;46(9):1245-55. doi: 10.1038/bmt.2010.288. Epub 2010 Dec 6.
Shelton ML, Lee JQ, Morris GS, Massey PR, Kendall DG, Munsell MF, Anderson KO, Simmonds MJ, Giralt SA. A randomized control trial of a supervised versus a self-directed exercise program for allogeneic stem cell transplant patients. Psychooncology. 2009 Apr;18(4):353-9. doi: 10.1002/pon.1505.
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.
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.
Bird L, Arthur A, Niblock T, Stone R, Watson L, Cox K. Rehabilitation programme after stem cell transplantation: randomized controlled trial. J Adv Nurs. 2010 Mar;66(3):607-15. doi: 10.1111/j.1365-2648.2009.05232.x.
Primary Completion
November 2014
Actual (reported)Study Completion
December 2017
Actual (reported)Last Updated
April 16, 2019
Record last verified: 2019-04
There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared.
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Source: ClinicalTrials.gov.
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