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

Hematologic Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212560
• Other study ID #: Gazi University1
• Status: Completed
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancies

Locations

Country	Name	City	State
Turkey	Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation	Yenimahalle

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional exercise capacity	Evaluated using 6-minute walking test	first day
Primary	Physical activity	Evaluated using a metabolic holter	first day
Primary	General quality of life	Evaluated using QOL using European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)	second day
Primary	Disease-specific quality of life	The Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)	second day
Primary	FACT	The Functional Assessment of Cancer Therapy-Anemia (FACT-An)	second day
Secondary	Pulmonary functions	Evaluated using spirometer	first day
Secondary	Muscle strength	Evaluated using hand-held dynamometer for peripheral muscles (shoulder abduction, shoulder flexion, knee extension, hand grip strength)	second day
Secondary	Respiratory muscle strength	Evaluated using mouth pressure device	second day
Secondary	Respiratory muscle endurance	Evaluated using respiratory muscle trainer (POWERbreathe)	second day
Secondary	Fatigue	Evaluated using Fatigue Severity Scale	second day
Secondary	Dyspnea	Evaluated using Modified Medical Research Council Dyspnea scale (MMRC)	first day
Secondary	Activity dyspnea	Evaluated using Modified Borg Scale	first day
Secondary	Anxiety	Evaluated using Hospital Anxiety and Depression Scale	second day
Secondary	Depression	Montgomery-Åsberg Depression Rating Scale	second day
Secondary	Hospital depression	Evaluated using Hospital Anxiety and Depression Scale	second day

External Links

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