Physical Deteriorations in Allo-HSCT.

NCT03606005 | Completed

• 1 other identifier: Gazi University 12
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Stem Cell Transplantation

Keywords

stem cell transplantation; Pulmonary Functions; exercise capacity; dyspnea; Quality of Life; physical activity

Outcome Measures

Primary Outcomes (1)

• 6-minute walk test (6-MWT)

  Submaximal exercise capacity was evaluated with this test.

  10 minutes

Secondary Outcomes (4)

• Pulmonary function test

  5 minutes

• Dyspnea scale

  2 minutes

• Physical activity measurement

  3 days

• Quality of life Scale

  2 minutes

Study Arms (2)

Group 1: Allogeneic-HSCT recipients

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.

Group 2: Healthy individuals

Healthy individuals were selected from individuals without known and diagnosed any chronic diseases. Similar measurements were applicated in healthy individuals.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• being 18-70 years of age
• being individuals without known and diagnosed any chronic diseases
• being current smokers
• being ex-smokers (≥5 packyears).

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (9)

• 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.

  PMID: 29720705 BACKGROUND

• 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.

  PMID: 25797423 BACKGROUND

• 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.

  PMID: 20656930 BACKGROUND

• 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.

  PMID: 21464398 BACKGROUND

• 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.

  PMID: 29889152 BACKGROUND

• 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.

  PMID: 16002928 BACKGROUND

• 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.

  PMID: 18264142 BACKGROUND

• 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.

  PMID: 29372395 BACKGROUND

• 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.

  PMID: 29269801 BACKGROUND

MeSH Terms

Conditions

Dyspnea; Motor Activity

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Gülşah Barğı, PhD

  Gazi University

  STUDY CHAIR

• Meral Boşnak Güçlü, PhD

  Gazi University

  STUDY DIRECTOR

• Gülsan Türköz Sucak, PhD.

  Medicalpark Bahçelievler Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 22, 2018
• First Posted: July 30, 2018
• Study Start: March 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2018
• Last Updated: May 28, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)