Exercise Capacity and Physical Activity Levels in Newly Diagnosed Hematologic Malignant Patients

Study Overview
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Brief Summary
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Hematologic malignancies are neoplasms that affect the blood, bone marrow, and lymph nodes. Hematological malignancies are the most common forms of leukemia, lymphoma, and myeloma, with numerous subtypes. The general symptoms of leukemia are fatigue, increased susceptibility to infection, bleeding, and the formation of bruises easily. Typical lymphoma symptoms are night sweats and involuntary weight loss, recurrent fever, fatigue, and itching. Myeloma patients often have bone pain, fatigue, anemia, hypercalcemia or infection symptoms. Adverse effects of hematologic malignancies and treatments cause abnormality in physical function and quality of life. Treatments such as chemotherapy, radiotherapy and hematopoietic stem cell transplantation, which may have side effects on the body systems are used in early or late period. The most common side effect due to chemotherapy is fatigue. Vomiting, weight loss, anemia, depression, decreased aerobic capacity, loss of muscle strength, decreased physical functioning and deterioration in the quality of life are indirect side effects seen in patients. In the literature, side effects of hematological malignancies have been investigated after treatment in patients. However, no study investigated exercise capacity, quality of life, physical activity level and pulmonary functions on newly diagnosed hematologic malignant patients. Therefore, the investigators aimed to compare aforementioned outcomes in newly diagnosed hematologic malignant patients and healthy controls.

Detailed Description
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According to sample size calculation 30 newly diagnosed hematologic malignant patients and 30 healthy individuals will be included. Before treatment submaximal exercise capacity, physical activity, quality of life, pulmonary functions, respiratory and peripheral muscle strength, respiratory muscle endurance, dyspnea and fatigue perception, anxiety and depression will be evaluated. Primary outcome measurements are exercise capacity, physical activity, quality of life, secondary outcomes are respiratory and peripheral muscle strength, respiratory muscle endurance, pulmonary functions, dyspnea and fatigue perception, anxiety and depression.

Official Title
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Exercise Capacity, Physical Activity Level and Quality of Life in Newly Diagnosed Hematologic Malignant Patients

Conditions
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Hematologic Malignancies

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed hematological malignant patients 18-65 years of age under standard medications. Exclusion Criteria: having cognitive disorder, orthopedic or neurological disease with a potential to affect functional capacity, comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute infections or pneumonia, problems which may prevent evaluating such as visual problems and mucositis having metastasis to any region (bone etc.) having acute hemorrhage in the intracranial and / or lung and other areas having any contraindication to exercise training

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Newly diagnosed individuals<br>Newly diagnosed hematologic malignant patients included in the study. Inclusion and exclusion criteria were considered. | |
| Healthy individuals<br>Those without chronic disease were included in the study. Inclusion and exclusion criteria were considered. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional exercise capacity | Evaluated using 6-minute walking test | first day | 
| Physical activity | Evaluated using a metabolic holter | first day | 
| General quality of life | Evaluated using QOL using European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL) | second day | 
| Disease-specific quality of life | The Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) | second day | 
| FACT | The Functional Assessment of Cancer Therapy-Anemia (FACT-An) | second day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary functions | Evaluated using spirometer | first day | 
| Muscle strength | Evaluated using hand-held dynamometer for peripheral muscles (shoulder abduction, shoulder flexion, knee extension, hand grip strength) | second day | 
| Respiratory muscle strength | Evaluated using mouth pressure device | second day | 
| Respiratory muscle endurance | Evaluated using respiratory muscle trainer (POWERbreathe) | second day | 
| Fatigue | Evaluated using Fatigue Severity Scale | second day | 
| Dyspnea | Evaluated using Modified Medical Research Council Dyspnea scale (MMRC) | first day | 
| Activity dyspnea | Evaluated using Modified Borg Scale | first day | 
| Anxiety | Evaluated using Hospital Anxiety and Depression Scale | second day | 
| Depression | Montgomery-Åsberg Depression Rating Scale | second day | 
| Hospital depression | Evaluated using Hospital Anxiety and Depression Scale | second day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle strength, Exercise capacity, Physical activity, Quality of life, Pulmonary functions, Respiratory muscle strength, Respiratory muscle endurance, Dyspnea, Anxiety, Fatigue