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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03212560
Enrollment
30
Registered
2017-07-11
Start date
2016-10-31
Completion date
2018-12-31
Last updated
2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Malignancies

Keywords

Exercise capacity, Physical activity, Quality of life, Pulmonary functions, Muscle strength, Respiratory muscle strength, Respiratory muscle endurance, Dyspnea, Anxiety, Fatigue

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.

Interventions

None listed

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Functional exercise capacityfirst dayEvaluated using 6-minute walking test
Physical activityfirst dayEvaluated using a metabolic holter
General quality of lifesecond dayEvaluated using QOL using European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)
Disease-specific quality of lifesecond dayThe Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)
FACTsecond dayThe Functional Assessment of Cancer Therapy-Anemia (FACT-An)

Secondary

MeasureTime frameDescription
Dyspneafirst dayEvaluated using Modified Medical Research Council Dyspnea scale (MMRC)
Activity dyspneafirst dayEvaluated using Modified Borg Scale
Pulmonary functionsfirst dayEvaluated using spirometer
Depressionsecond dayMontgomery-Åsberg Depression Rating Scale
Hospital depressionsecond dayEvaluated using Hospital Anxiety and Depression Scale
Anxietysecond dayEvaluated using Hospital Anxiety and Depression Scale
Muscle strengthsecond dayEvaluated using hand-held dynamometer for peripheral muscles (shoulder abduction, shoulder flexion, knee extension, hand grip strength)
Respiratory muscle strengthsecond dayEvaluated using mouth pressure device
Respiratory muscle endurancesecond dayEvaluated using respiratory muscle trainer (POWERbreathe)
Fatiguesecond dayEvaluated using Fatigue Severity Scale

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026