Clinical trial NCT03212560: Exercise Capacity and Physical Activity Levels in Newly Diagnosed Hematologic Malignant Patients
Official title: Exercise Capacity, Physical Activity Level and Quality of Life in Newly Diagnosed Hematologic Malignant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Malignancies
Keywords: Exercise capacity
Physical activity
Quality of life
Pulmonary functions
Muscle strength
Respiratory muscle strength
Respiratory muscle endurance
Dyspnea
Anxiety
Fatigue
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients and healthy volunteers

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional exercise capacity
timeFrame: first day
measure: Physical activity
timeFrame: first day
measure: General quality of life
timeFrame: second day
measure: Disease-specific quality of life
timeFrame: second day
measure: FACT
timeFrame: second day
Secondary outcomes:
measure: Pulmonary functions
timeFrame: first day
measure: Muscle strength
timeFrame: second day
measure: Respiratory muscle strength
timeFrame: second day
measure: Respiratory muscle endurance
timeFrame: second day
measure: Fatigue
timeFrame: second day
measure: Dyspnea
timeFrame: first day
measure: Activity dyspnea
timeFrame: first day
measure: Anxiety
timeFrame: second day
measure: Depression
timeFrame: second day
measure: Hospital depression
timeFrame: second day
Other outcomes:
Locations:
city: Yenimahalle
country: Turkey
facility: Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
Study officials:
affiliation: Research assistant
name: Zeliha Çelik, Pt
role: STUDY_CHAIR
affiliation: Associate professor
name: Meral Boşnak Güçlü, Pt, Phd
role: STUDY_DIRECTOR
affiliation: Associate professor
name: Zübeyde Nur Özkurt, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: