Deteriorations in Dyspnea, Exercise Capacity, Physical Activity and Quality of Life of Allogeneic Hematopoietic Stem Cell Transplantation Survivors Versus Healthy Individuals: a Retrospective, Cross Sectional Study
Sponsor study identifier
observational
144
1 country
1
Study Start
March 2012
Actual (reported)Primary Completion
August 2017
Actual (reported)Study Completion
October 2018
Actual (reported)Limited number of studies reported impairments in physical activity, exercise capacity and quality of life of allogeneic hematopoietic stem cell transplantation (allogeneic-HSCT) recipients. However, comparison of dyspnea, exercise capacity, physical activity level and quality of life in allogeneic-HSCT recipients versus age-gender matched healthy individuals have not been known so far.To compare dyspnea, submaximal exercise capacity, physical activity level and quality of life in allogeneic-HSCT recipients with healthy individuals.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2018
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)August 2017
Actual (reported)July 22, 2018
Actual (reported)July 30, 2018
Actual (reported)October 2018
Actual (reported)6-minute walk test (6-MWT)
Submaximal exercise capacity was evaluated with this test.
10 minutes
Pulmonary function test
5 minutes
Dyspnea scale
2 minutes
Physical activity measurement
3 days
Quality of life Scale
2 minutes
Dyspnea \[Modified Medical Research Council dyspnea scale (MMRC)\], submaximal exercise capacity \[6-minute walk test (6-MWT)\], physical activity level \[metabolic holter\], quality of life \[European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQOL)\] and pulmonary functions \[spirometry\] were evaluated in allogeneic-HSCT recipients (.Vital signs, dyspnea and fatigue perception \[Modified Borg Scale\] were recorded as pre-post measurements of 6-MWT.
Healthy individuals were selected from individuals without known and diagnosed any chronic diseases. Similar measurements were applicated in healthy individuals.
All allogeneic-HSCT recipients in Bone Marrow Transplantation Unit of University were referred for rehabilitation to Unit of Faculty of Health Science, Department of Physiotherapy and Rehabilitation as outpatient. Allogeneic-HSCT recipients (n=82) and aged-gender matched healthy individuals (n=63) were evaluated and compared.Recipients and healthy individuals were matched with regard to age and gender. Study was planned as prospective, cross sectional and approved by local Ethics Committee. Informed consent was obtained from all individual participants included in study.
Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation
Ankara, 06010, Turkey (Türkiye)
Mohty M, Duarte RF, Kuball J, Bader P, Basak GW, Bonini C, Carreras E, Chabannon C, Dufour C, Gennery A, Lankester A, Lanza F, Ljungman P, Montoto S, Nagler A, Snowden JA, Styczynski J, Sureda A, Kroger N. Recommendations from the European Society for Blood and Marrow Transplantation (EBMT) for a curriculum in hematopoietic cell transplantation. Bone Marrow Transplant. 2018 Dec;53(12):1548-1552. doi: 10.1038/s41409-018-0190-9. Epub 2018 May 2.
Hilgendorf I, Greinix H, Halter JP, Lawitschka A, Bertz H, Wolff D. Long-term follow-up after allogeneic stem cell transplantation. Dtsch Arztebl Int. 2015 Jan 23;112(4):51-8. doi: 10.3238/arztebl.2015.0051.
Gülşah Barğı, PhD
Gazi University
Meral Boşnak Güçlü, PhD
Gazi University
Gülsan Türköz Sucak, PhD.
Medicalpark Bahçelievler Hospital
144 participants (actual enrollment reported by the registry).
First Submitted
July 22, 2018
First Posted
July 30, 2018
Study Start
March 2012
Actual (reported)Contact the study team to confirm eligibility.
Sun CL, Francisco L, Kawashima T, Leisenring W, Robison LL, Baker KS, Weisdorf DJ, Forman SJ, Bhatia S. Prevalence and predictors of chronic health conditions after hematopoietic cell transplantation: a report from the Bone Marrow Transplant Survivor Study. Blood. 2010 Oct 28;116(17):3129-39; quiz 3377. doi: 10.1182/blood-2009-06-229369. Epub 2010 Jul 23.
Wingard JR, Majhail NS, Brazauskas R, Wang Z, Sobocinski KA, Jacobsohn D, Sorror ML, Horowitz MM, Bolwell B, Rizzo JD, Socie G. Long-term survival and late deaths after allogeneic hematopoietic cell transplantation. J Clin Oncol. 2011 Jun 1;29(16):2230-9. doi: 10.1200/JCO.2010.33.7212. Epub 2011 Apr 4.
Gea-Banacloche J. Pulmonary infectious complications after hematopoietic stem cell transplantation: a practical guide to clinicians. Curr Opin Organ Transplant. 2018 Aug;23(4):375-380. doi: 10.1097/MOT.0000000000000549.
White AC, Terrin N, Miller KB, Ryan HF. Impaired respiratory and skeletal muscle strength in patients prior to hematopoietic stem-cell transplantation. Chest. 2005 Jul;128(1):145-52. doi: 10.1378/chest.128.1.145.
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.
Wakasugi T, Morishita S, Kaida K, Itani Y, Kodama N, Ikegame K, Ogawa H, Domen K. Impaired skeletal muscle oxygenation following allogeneic hematopoietic stem cell transplantation is associated with exercise capacity. Support Care Cancer. 2018 Jul;26(7):2149-2160. doi: 10.1007/s00520-017-4036-6. Epub 2018 Jan 25.
Dirou S, Chambellan A, Chevallier P, Germaud P, Lamirault G, Gourraud PA, Perrot B, Delasalle B, Forestier B, Guillaume T, Peterlin P, Garnier A, Magnan A, Blanc FX, Lemarchand P. Deconditioning, fatigue and impaired quality of life in long-term survivors after allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2018 Mar;53(3):281-290. doi: 10.1038/s41409-017-0057-5. Epub 2017 Dec 21.
Primary Completion
August 2017
Actual (reported)Study Completion
October 2018
Actual (reported)Last Updated
May 28, 2019
Record last verified: 2019-05
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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