Physical Deteriorations in Allo-HSCT.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Deteriorations in Dyspnea, Exercise Capacity, Physical Activity and Quality of Life of Allogeneic Hematopoietic Stem Cell Transplantation Survivors Versus Healthy Individuals: a Retrospective, Cross Sectional Study

Conditions
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Stem Cell Transplantation

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Allogeneic-HSCT recipients<br>Dyspnea [Modified Medical Research Council dyspnea scale (MMRC)], submaximal exercise capacity [6-minute walk test (6-MWT)], physical activity level [metabolic holter], quality of life [European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQOL)] and pulmonary functions [spirometry] were evaluated in allogeneic-HSCT recipients (.Vital signs, dyspnea and fatigue perception [Modified Borg Scale] were recorded as pre-post measurements of 6-MWT. | |
| Group 2: Healthy individuals<br>Healthy individuals were selected from individuals without known and diagnosed any chronic diseases. Similar measurements were applicated in healthy individuals. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk test (6-MWT) | Submaximal exercise capacity was evaluated with this test. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function test | Pulmonary functions were evaluated using a spirometry. | 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. | 2 minutes | 
| Physical activity measurement | For this evaluation, a metabolic holter was used. | 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. | 2 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise capacity, dyspnea, Quality of Life, physical activity, stem cell transplantation, Pulmonary Functions