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

NCT03212560 | Completed

• 1 other identifier: Gazi University1
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancies

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Functional exercise capacity

  Evaluated using 6-minute walking test

  first day

• Physical activity

  Evaluated using a metabolic holter

  first day

• General quality of life

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

  second day

• Disease-specific quality of life

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

  second day

• FACT

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

  second day

Secondary Outcomes (10)

• Pulmonary functions

  first day

• Muscle strength

  second day

• Respiratory muscle strength

  second day

• Respiratory muscle endurance

  second day

• Fatigue

  second day

Study Arms (2)

Newly diagnosed individuals

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

Healthy individuals

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients and healthy volunteers

You may qualify if:

• Newly diagnosed hematological malignant patients
• years of age
• under standard medications.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Yenimahalle, Turkey (Türkiye)

Location

Related Links

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MeSH Terms

Conditions

Hematologic Neoplasms; Motor Activity; Dyspnea; Anxiety Disorders; Fatigue

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Behavior; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Zeliha Çelik, Pt

  Research assistant

  STUDY CHAIR

• Meral Boşnak Güçlü, Pt, Phd

  Associate professor

  STUDY DIRECTOR

• Zübeyde Nur Özkurt, MD, Phd

  Associate professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 11, 2017
• Study Start: October 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)