NCT03699358

Brief Summary

Hematologic malignancies may arise from myeloid and lymphoid blood cells lineages affecting blood, bone marrow and lymph nodes. Accordingly, negative effects of malignancies on body systems vary. As known, muscle strength, exercise capacity, fatigue and quality of life deteriorate during allogeneic hematopoietic stem cell transplantation (HSCT). However, impacts of myeloid and lymphoid type disorders on pulmonary functions, muscle strength, exercise capacity, fatigue and quality of life in allogeneic-HSCT who diagnosed with hematologic malignancies. Therefore, current study aimed to comparatively investigate physical impairments between recipients with hematologic malignancies according to myeloid and lymphoid type disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
Last Updated

July 1, 2019

Status Verified

June 1, 2019

Enrollment Period

5.1 years

First QC Date

October 5, 2018

Last Update Submit

June 27, 2019

Conditions

Keywords

hematopoietic stem cell transplantationrespiratory function testrespiratory musclesmuscle strengthexercisewalk testquality of life

Outcome Measures

Primary Outcomes (1)

  • Maximal exercise capacity evaluation

    Modified-Incremental Shuttle Walk Test (ISWT) test was used to evaluate maximal exercise capaciity.

    15-20 minutes

Secondary Outcomes (4)

  • pulmonary function test

    5 minutes

  • Inspiratory and expiratory muscle strength (MIP, MEP)

    5-10 minutes

  • Quadriceps femoris muscle strength

    5 minutes

  • Quality of life level

    2 minutes

Study Arms (2)

Group 1: Myeloid recipients

Patients diagnosed with hematologic malignancy were recipients who undergone allogeneic-HSCT. Recipients were included in the current study and grouped as myeloid and lymphoid according to origin of their diagnosis. Recipients who had myeloid type disorders were included in myeloid group as well as recipients who had lymphoid type disorders were included in lymphoid group.

Group 2: Lymphoid recipients

Patients diagnosed with hematologic malignancy were recipients who undergone allogeneic-HSCT. Recipients were included in the current study and grouped as myeloid and lymphoid according to origin of their diagnosis. Recipients who had myeloid type disorders were included in myeloid group as well as recipients who had lymphoid type disorders were included in lymphoid group.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients in Bone Marrow Transplantation Unit of University were referred for participation in rehabilitation program as outpatient to Faculty of Health Science of University, Department of Physiotherapy and Rehabilitation, cardiopulmonary rehabilitation unit. Patients diagnosed with hematologic malignancy were recipients who undergone allogeneic-HSCT. Recipients who had myeloid type disorders were included in myeloid group as well as recipients who had lymphoid type disorders were included in lymphoid group. A physiotherapist conducted all measurements in the same day for all recipients individually.

You may qualify if:

  • years of age,
  • being an allogeneic-HSCT recipient who was at minimum 100 days status after transplantation
  • receiving optimal standard medical therapy including immunosuppressive agents, antibiotics, supplements and other drugs.

You may not qualify if:

  • having cognitive disorders, orthopedic or neurological disease with a potential to affect assessment of exercise capacity, visual impairments and mucositis which may prevent measurements, comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute respiratory or other infections, acute hemorrhage, low hemoglobin values (≤8 g/L) and low platelet count (≤10.000 mm3).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Health Science Department of PhysioTherapy

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (4)

  • Paul KL. Rehabilitation and exercise considerations in hematologic malignancies. Am J Phys Med Rehabil. 2011 May;90(5 Suppl 1):S88-94. doi: 10.1097/PHM.0b013e31820be055.

    PMID: 21765268BACKGROUND
  • Bergenthal N, Will A, Streckmann F, Wolkewitz KD, Monsef I, Engert A, Elter T, Skoetz N. Aerobic physical exercise for adult patients with haematological malignancies. Cochrane Database Syst Rev. 2014 Nov 11;(11):CD009075. doi: 10.1002/14651858.CD009075.pub2.

    PMID: 25386666BACKGROUND
  • Steinberg A, Asher A, Bailey C, Fu JB. The role of physical rehabilitation in stem cell transplantation patients. Support Care Cancer. 2015 Aug;23(8):2447-60. doi: 10.1007/s00520-015-2744-3. Epub 2015 May 14.

    PMID: 25971213BACKGROUND
  • Bargi G, Bosnak Guclu M, Turkoz Sucak AG. Differences in pulmonary and extra-pulmonary characteristics in severely versus non-severely fatigued recipients of allogeneic hematopoietic stem cell transplantation: a cross-sectional, comparative study. Hematology. 2019 Dec;24(1):112-122. doi: 10.1080/10245332.2018.1526441. Epub 2018 Sep 27.

    PMID: 30261831BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Gülşah Barğı, PhD

    Gazi University

    STUDY CHAIR
  • Meral Boşnak Güçlü, PhD

    Gazi University

    STUDY DIRECTOR
  • Gülsan Türköz Sucak, PhD.

    Bahçeşehir University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 9, 2018

Study Start

March 1, 2012

Primary Completion

April 1, 2017

Study Completion

August 1, 2017

Last Updated

July 1, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

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.

Locations