Physical Impairments in Allogeneic-HSCT

NCT03448627 | Completed

• 1 other identifier: GaziUniversity6
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stem Cell Transplantation

Keywords

stem cell transplantation; Pulmonary Functions; muscle strength; exercise capacity

Outcome Measures

Primary Outcomes (1)

• Modified-Incremental Shuttle Walk Test (ISWT)

  This test was used to evaluate maximal exercise capacity

  15-20 minutes

Secondary Outcomes (3)

• pulmonary function test

  5 minutes

• inspiratory and expiratory muscle strength (MIP, MEP)

  5-10 minutes

• Quadriceps femoris muscle strength

  5 minutes

Study Arms (2)

Group 1: HSCT recipients

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.

Group 2: healthy individuals

Healthy individuals (n=50) 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

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.

You may qualify if:

• between ages of 18 and 70
• under standard medical treatment
• 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 maximal 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 individuals without known and diagnosed any chronic diseases
• not actively smoking
• their cigarette exposure is not greater than 5 pack\*year.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Health Science Department of PhysioTherapy

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (7)

• 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 RESULT

• 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.

  PMID: 23475197 RESULT

• 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.

  PMID: 21132025 RESULT

• 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.

  PMID: 19117328 RESULT

• 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.

  PMID: 28220548 RESULT

• 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.

  PMID: 26135532 RESULT

• 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.

  PMID: 20423395 RESULT

Study Officials

• Gülşah Barğı, PhD

  Gazi University

  STUDY CHAIR

• Meral Boşnak Güçlü, PhD

  Gazi University

  STUDY DIRECTOR

• Gülsan Türköz Sucak

  Bahçeşehir University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: February 28, 2018
• Study Start: March 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2017
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)