Physical Impairments Related to Myeloid and Lymphoid Malignancies

Completed

• Conditions: Stem Cell Transplantation

• Registration Number: NCT03699358
• Lead Sponsor: Gazi University

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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2017-04
• Study Completion: 2017-08
• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-27
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximal exercise capacity evaluation	15-20 minutes	Modified-Incremental Shuttle Walk Test (ISWT) test was used to evaluate maximal exercise capaciity.

Secondary Outcome Measures

Name	Time	Method
pulmonary function test	5 minutes	This test was evaluated using a spirometry
Inspiratory and expiratory muscle strength (MIP, MEP)	5-10 minutes	Respiratory muscle strength was evaluated with a mouth pressure device
Quadriceps femoris muscle strength	5 minutes	Peripheral muscle strength was evaluated with a hand-held dynamometer
Quality of life level	2 minutes	The Turkish version of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version3.0 (EORTC QLQ-C30) was carried out to the recipients for evaluation of aspects of quality of life impairment which is a valid and reliable questionnaire for patients with cancer in the whole world.Self-administered questionnaire incorporates five functional scales including social functioning subscale, three symptom scales including fatigue subscale, and a global health status as well as several single items. All item scores are transformed to percents (0-100). Higher values represent higher functional/healthy level in functional scales, a higher quality of life level in global health status and increased presence of symptoms in symptom scales.

Trial Locations

Locations (1)

Gazi University Faculty of Health Science Department of PhysioTherapy; 🇹🇷 Ankara, Turkey