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

NCT ID: NCT03212560

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-31

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.

Conditions

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Hematologic Malignancies

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Newly diagnosed individuals

Newly diagnosed hematologic malignant patients included in the study. Inclusion and exclusion criteria were considered.

No interventions assigned to this group

Healthy individuals

Those without chronic disease were included in the study. Inclusion and exclusion criteria were considered.

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Meral Boşnak Güçlü

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeliha Çelik, Pt

Role: STUDY_CHAIR

Research assistant

Meral Boşnak Güçlü, Pt, Phd

Role: STUDY_DIRECTOR

Associate professor

Zübeyde Nur Özkurt, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Associate professor

Locations

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

Yenimahalle, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Gazi University1

Identifier Type: -

Identifier Source: org_study_id

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