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NCT Number: NCT03212560

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

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.

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Key information

Conditions

Hematologic Malignancies Anxiety Disorders Behavior Dyspnea Fatigue Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Mental Disorders Motor Activity Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

Yenimahalle, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Functional exercise capacity

    Time frame: first day

    Evaluated using 6-minute walking test

  2. Physical activity

    Time frame: first day

    Evaluated using a metabolic holter

  3. General quality of life

    Time frame: second day

    Evaluated using QOL using European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)

  4. Disease-specific quality of life

    Time frame: second day

    The Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)

  5. FACT

    Time frame: second day

    The Functional Assessment of Cancer Therapy-Anemia (FACT-An)

Secondary outcomes

  1. Pulmonary functions

    Time frame: first day

    Evaluated using spirometer

  2. Muscle strength

    Time frame: second day

    Evaluated using hand-held dynamometer for peripheral muscles (shoulder abduction, shoulder flexion, knee extension, hand grip strength)

  3. Respiratory muscle strength

    Time frame: second day

    Evaluated using mouth pressure device

  4. Respiratory muscle endurance

    Time frame: second day

    Evaluated using respiratory muscle trainer (POWERbreathe)

  5. Fatigue

    Time frame: second day

    Evaluated using Fatigue Severity Scale

  6. Dyspnea

    Time frame: first day

    Evaluated using Modified Medical Research Council Dyspnea scale (MMRC)

  7. Activity dyspnea

    Time frame: first day

    Evaluated using Modified Borg Scale

  8. Anxiety

    Time frame: second day

    Evaluated using Hospital Anxiety and Depression Scale

  9. Depression

    Time frame: second day

    Montgomery-Åsberg Depression Rating Scale

  10. Hospital depression

    Time frame: second day

    Evaluated using Hospital Anxiety and Depression Scale

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 11, 2017
Registry last updated
Feb 15, 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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