Hematologic MalignanciesNCT03212560
Exercise Capacity and Physical Activity Levels in Newly Diagnosed Hematologic Malignant Patients
An observational study of Hematologic Malignancies, run by Gazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hematologic Malignancies
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2016to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospitalized patients and healthy volunteers
Who may be able to join
- Newly diagnosed hematological malignant patients
- 18-65 years of age
- under standard medications.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
Yenimahalle
About this study
Official title: Exercise Capacity, Physical Activity Level and Quality of Life in Newly Diagnosed Hematologic Malignant Patients
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.
Read the 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.
- Conditions
- Hematologic Malignancies
- Keywords
- Exercise capacity, Physical activity, Quality of life, Pulmonary functions, Muscle strength, Respiratory muscle strength, Respiratory muscle endurance, Dyspnea, Anxiety, Fatigue
- Medical subject headings
- Hematologic Neoplasms, Motor Activity, Dyspnea, Anxiety Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional exercise capacity
Evaluated using 6-minute walking test
Measured: first day
Physical activity
Evaluated using a metabolic holter
Measured: first day
General quality of life
Evaluated using QOL using European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)
Measured: second day
Disease-specific quality of life
The Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)
Measured: second day
FACT
The Functional Assessment of Cancer Therapy-Anemia (FACT-An)
Measured: second day
Secondary outcomes (10)
Pulmonary functions
Evaluated using spirometer
Measured: first day
Muscle strength
Evaluated using hand-held dynamometer for peripheral muscles (shoulder abduction, shoulder flexion, knee extension, hand grip strength)
Measured: second day
Respiratory muscle strength
Evaluated using mouth pressure device
Measured: second day
Respiratory muscle endurance
Evaluated using respiratory muscle trainer (POWERbreathe)
Measured: second day
Fatigue
Evaluated using Fatigue Severity Scale
Measured: second day
Dyspnea
Evaluated using Modified Medical Research Council Dyspnea scale (MMRC)
Measured: first day
Activity dyspnea
Evaluated using Modified Borg Scale
Measured: first day
Anxiety
Evaluated using Hospital Anxiety and Depression Scale
Measured: second day
Depression
Montgomery-Åsberg Depression Rating Scale
Measured: second day
Hospital depression
Evaluated using Hospital Anxiety and Depression Scale
Measured: second day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startOct 2016
- Primary completionSep 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Zeliha Çelik, Pt, Study chair, Research assistantMeral Boşnak Güçlü, Pt, Phd, Study director, Associate professorZübeyde Nur Özkurt, MD, Phd, Principal investigator, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212560
- Sponsor's protocol ID
- Gazi University1
- Status last verified
- Feb 2019
- First submitted
- 3 Jul 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Capacity, Physical Activity Level and Quality of Life in Newly Diagnosed Hematologic Malignant Patients
- ClinicalTrials.gov ID
- NCT03212560
- Acronym / sponsor ID
- Gazi University1
- Conditions
- Hematologic Malignancies
- Keywords
- Exercise capacity, Physical activity, Quality of life, Pulmonary functions, Muscle strength, Respiratory muscle strength, Respiratory muscle endurance, Dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients and healthy volunteers
Key inclusion criteria (3 listed)
- Newly diagnosed hematological malignant patients
- 18-65 years of age
- under standard medications.
Key exclusion criteria (7 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional exercise capacity
Time frame: first day
Evaluated using 6-minute walking test
Physical activity
Time frame: first day
Evaluated using a metabolic holter
General quality of life
Time frame: second day
Evaluated using QOL using European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)
Disease-specific quality of life
Time frame: second day
The Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)
FACT
Time frame: second day
The Functional Assessment of Cancer Therapy-Anemia (FACT-An)
10 secondary outcomes
Pulmonary functions
Time frame: first day
Muscle strength
Time frame: second day
Respiratory muscle strength
Time frame: second day
Respiratory muscle endurance
Time frame: second day
Fatigue
Time frame: second day
Dyspnea
Time frame: first day
Activity dyspnea
Time frame: first day
Anxiety
Time frame: second day
Depression
Time frame: second day
Hospital depression
Time frame: second day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeliha Çelik, Pt study chair
Research assistant
Meral Boşnak Güçlü, Pt, Phd study director
Associate professor
Zübeyde Nur Özkurt, MD, Phd principal investigator
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Malignancies, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional exercise capacity (time frame: first day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.