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Clinical Trials/NCT03699358
NCT03699358
Completed
Not Applicable

Does Myeloid or Lymphoid Origin of Hematologic Neoplasm Affect Pulmonary Functions, Muscle Strength, Exercise Capacity, Fatigue and Quality of Life?

Gazi University1 site in 1 country57 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stem Cell Transplantation
Sponsor
Gazi University
Enrollment
57
Locations
1
Primary Endpoint
Maximal exercise capacity evaluation
Status
Completed
Last Updated
6 years ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
August 2017
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meral Boşnak Güçlü

Associate professor

Gazi University

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Maximal exercise capacity evaluation

Time Frame: 15-20 minutes

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

Secondary Outcomes

  • 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 Sites (1)

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