Clinical trial NCT03606005: Physical Deteriorations in Allo-HSCT.
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stem Cell Transplantation
Keywords: stem cell transplantation
Pulmonary Functions
exercise capacity
dyspnea
Quality of Life
physical activity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: Hematopoietic stem cell transplantation (HSCT) is a prevalent curative treatment approach for a large variety of diseases affecting hematopoietic systems. More than 50.000 HSCT are implemented all over the world annually. Despite having complex aspect, allogeneic-HSCT also serves as an important chance of survival and cure for patients with hematological malignancies. Allogeneic-HSCT recipients have at least 2-year survival rate, yet long term complications such as chronic health conditions, life-threatening diseases, musculoskeletal and cardiopulmonary disorders may occur in recipients following HSCT due to general state of immunosuppression and medications. Besides pulmonary complications existed in 30-50% of HSCT recipients, pulmonary infiltrates especially after allogeneic HSCT is an ongoing challenge for recipients. All toxic treatments received to cure hematological malignancies including HSCT and various complications seen after HSCT may induce muscle weakness, decreased submaximal exercise capacity and oxygen consumption via impaired skeletal muscle oxygenation in most allogeneic-HSCT long-term survivors. Therefore, European Society for Blood and Marrow Transplantation Group recommends that allied health-care professionals should take part in team for a successful dynamic process of allogeneic-HSCT.

Limited number of studies reported impairments in exercise capacity, physical activity and quality of life in allogeneic-HSCT recipients. However it is not known that to what extent dyspnea, exercise capacity, physical activity and quality of life impair in allogeneic recipients who were over 100 days status post transplantation versus age-gender matched healthy individuals so far. Therefore aspiration of current study was comparison of dyspnea, submaximal exercise capacity, physical activity level and quality of life in allogeneic-HSCT recipients with healthy individuals.

Eligibility criteria: Inclusion Criteria for recipients:

* between ages of 18 and 70
* under standard medical treatment including immunosuppressive, antibiotics and other drugs
* underwent allogeneic HSCT who were at minimum 100 days status post-transplantation

Exclusion Criteria for recipients:

* having cognitive disorder, orthopedic or neurological disease with a potential to affect assessment of exercise capacity,
* having comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute respiratory or other infections,
* having problems like visual and mucositis which may prevent measurements,
* acute hemorrhage anywhere in the body,
* hemoglobin value less than 8 g/L and platelet count less than 10.000 mm3

Inclusion Criteria for healthy individuals:

* being 18-70 years of age
* being individuals without known and diagnosed any chronic diseases

Exclusion Criteria for healthy individuals:

* being current smokers
* being ex-smokers (≥5 packyears).

Primary outcomes:
measure: 6-minute walk test (6-MWT)
timeFrame: 10 minutes
Secondary outcomes:
measure: Pulmonary function test
timeFrame: 5 minutes
measure: Dyspnea scale
timeFrame: 2 minutes
measure: Physical activity measurement
timeFrame: 3 days
measure: Quality of life Scale
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation
Study officials:
affiliation: Gazi University
name: Gülşah Barğı, PhD
role: STUDY_CHAIR
affiliation: Gazi University
name: Meral Boşnak Güçlü, PhD
role: STUDY_DIRECTOR
affiliation: Medicalpark Bahçelievler Hospital
name: Gülsan Türköz Sucak, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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: 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.
citation: 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.