Physical Impairments Related to Myeloid and Lymphoid Malignancies

NCT ID: NCT03699358

Last Updated: 2019-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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Hematologic malignancies affecting blood, bone marrow and lymph nodes comprise neoplasm of either myeloid or lymphoid blood stem cells origin. While a lymphoid stem cell becomes a white blood cell, a myeloid stem cell becomes one of the red blood cells, white blood cells or platelets types. Due to the this reason, defects in myeloid stem cells result in acute and chronic myelogenous leukemia, myelodysplastic syndromes or myeloproliferative diseases, whereas defects in lymphoid stem cells result in lymphomas, lymphocytic leukemias or myeloma. On the other hand, most of these hematologic malignancies are characterized with high rate of morbidity and mortality because of both the nature and various toxic treatments of neoplasm including chemotherapy with multiple agents, corticosteroids and hematopoietic stem cell transplantation (HSCT). Especially after allogeneic-HSCT, recipients experience more impairments in pulmonary functions, respiratory and peripheral muscle strength, exercise capacity, perception of fatigue and quality of life scores which make their lives difficult in terms of actively trying to return to the their life. However, although it has been known that each hematologic disease has a different negative impact on varied body systems or organs after HSCT, little attention has been paid to the comparatively investigation of impacts of myeloid and lymphoid hematological malignancies on pulmonary functions, muscle strength, exercise capacity, fatigue and quality of life in allogeneic-HSCT recipients. Hence, current study aimed to comparatively investigate physical impairments between recipients with hematologic malignancies according to myeloid and lymphoid type disorder.

Recipients undergone allogeneic-HSCT (˃100 days post-HSCT status) were included. Hematologic malignancies were grouped as myeloid and lymphoid. Pulmonary functions (spirometry), peripheral (dynamometer) and respiratory muscle strength (MIP-MEP) (mouth pressure device), exercise capacity (Modified Incremental Shuttle Walk Test (ISWT)), and quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) were evaluated.

Conditions

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Stem Cell Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this 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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18-65 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.

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Meral Boşnak Güçlü

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülşah Barğı, PhD

Role: STUDY_CHAIR

Gazi University

Meral Boşnak Güçlü, PhD

Role: STUDY_DIRECTOR

Gazi University

Gülsan Türköz Sucak, PhD.

Role: PRINCIPAL_INVESTIGATOR

Bahçeşehir University

Locations

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Gazi University Faculty of Health Science Department of PhysioTherapy

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 21765268 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25386666 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25971213 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30261831 (View on PubMed)

Other Identifiers

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GaziUniversity15

Identifier Type: -

Identifier Source: org_study_id

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