Physical Deteriorations in Allo-HSCT.

Gazi University144 enrolled

Overview

Limited number of studies reported impairments in physical activity, exercise capacity and quality of life of allogeneic hematopoietic stem cell transplantation (allogeneic-HSCT) recipients. However, comparison of dyspnea, exercise capacity, physical activity level and quality of life in allogeneic-HSCT recipients versus age-gender matched healthy individuals have not been known so far.To compare dyspnea, submaximal exercise capacity, physical activity level and quality of life in allogeneic-HSCT recipients with healthy individuals.

Hematopoietic stem cell transplantation (HSCT) is a prevalent curative treatment approach for a large variety of diseases affecting hematopoietic systems. More than 50.000 HSCT are implemented all over the world annually. Despite having complex aspect, allogeneic-HSCT also serves as an important chance of survival and cure for patients with hematological malignancies. Allogeneic-HSCT recipients have at least 2-year survival rate, yet long term complications such as chronic health conditions, life-threatening diseases, musculoskeletal and cardiopulmonary disorders may occur in recipients following HSCT due to general state of immunosuppression and medications. Besides pulmonary complications existed in 30-50% of HSCT recipients, pulmonary infiltrates especially after allogeneic HSCT is an ongoing challenge for recipients. All toxic treatments received to cure hematological malignancies including HSCT and various complications seen after HSCT may induce muscle weakness, decreased submaximal exercise capacity and oxygen consumption via impaired skeletal muscle oxygenation in most allogeneic-HSCT long-term survivors. Therefore, European Society for Blood and Marrow Transplantation Group recommends that allied health-care professionals should take part in team for a successful dynamic process of allogeneic-HSCT. Limited number of studies reported impairments in exercise capacity, physical activity and quality of life in allogeneic-HSCT recipients. However it is not known that to what extent dyspnea, exercise capacity, physical activity and quality of life impair in allogeneic recipients who were over 100 days status post transplantation versus age-gender matched healthy individuals so far. Therefore aspiration of current study was comparison of dyspnea, submaximal exercise capacity, physical activity level and quality of life in allogeneic-HSCT recipients with healthy individuals.

Study Type

OBSERVATIONAL

Enrollment

144

Conditions

Stem Cell Transplantation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria for recipients: * between ages of 18 and 70 * under standard medical treatment including immunosuppressive, antibiotics and other drugs * underwent allogeneic HSCT who were at minimum 100 days status post-transplantation Exclusion Criteria for recipients: * having cognitive disorder, orthopedic or neurological disease with a potential to affect assessment of exercise capacity, * having comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute respiratory or other infections, * having problems like visual and mucositis which may prevent measurements, * acute hemorrhage anywhere in the body, * hemoglobin value less than 8 g/L and platelet count less than 10.000 mm3 Inclusion Criteria for healthy individuals: * being 18-70 years of age * being individuals without known and diagnosed any chronic diseases Exclusion Criteria for healthy individuals: * being current smokers * being ex-smokers (≥5 packyears).

Locations (1)

Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

6-minute walk test (6-MWT)

Submaximal exercise capacity was evaluated with this test.

Time frame: 10 minutes

Secondary Outcomes

Pulmonary function test

Pulmonary functions were evaluated using a spirometry.

Time frame: 5 minutes

Dyspnea scale

Severity of dyspnea during daily living activities was evaluated using Modified Medical Research Council (MMRC) dyspnea scale. Dyspnea is graded between zero (absence of dyspnea during strenuous exercise) to four (presence of dyspnea during all daily living activities). Minimal clinically important difference (MCID) is 1 U for MMRC dyspnea scale.

Time frame: 2 minutes

Physical activity measurement

For this evaluation, a metabolic holter was used.

Time frame: 3 days

Quality of life Scale

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version3.0 (EORTC QLQ-C30) was used to evaluate aspects of quality of life impairment. Self-administered questionnaire incorporates five functional scales including social functioning subscale, three symptom scales including fatigue subscale, a global health status and several single items. All item scores are transformed to 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.

Time frame: 2 minutes

Data from ClinicalTrials.gov

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