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Completed

NCT Number: NCT03699358

Physical Impairments Related to Myeloid and Lymphoid Malignancies

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University Faculty of Health Science Department of PhysioTherapy

Ankara, 06560, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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

  1. pulmonary function test

    Time frame: 5 minutes

    This test was evaluated using a spirometry

  2. Inspiratory and expiratory muscle strength (MIP, MEP)

    Time frame: 5-10 minutes

    Respiratory muscle strength was evaluated with a mouth pressure device

  3. Quadriceps femoris muscle strength

    Time frame: 5 minutes

    Peripheral muscle strength was evaluated with a hand-held dynamometer

  4. Quality of life level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 9, 2018
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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