Hematopoietic Stem Cell TransplantationNCT03007602
Effects of Upper Extremity Aerobic Exercise Training in Hematopoietic Stem Cell Transplantation Recipients
A study testing Upper Extremity Aerobic Exercise in people with Hematopoietic Stem Cell Transplantation and Aerobic Exercise, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Hematologic malignancy is a tumor of myeloid or lymphatic cells that affects lymph nodes with the involvement of blood, bone marrow or other organs.There are various treatment options for hematological malignancies ranging from follow-up to single or multiple agent chemotherapy, radiotherapy, immunotherapy and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Aerobic Exercise
- What is being tested?
- Upper Extremity Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2016to Sep 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being an hematopoietic stem cell transplantation recipient during the intermediate/late post-transplant phase (>100 days),
- 18-65 years of age
- under standard medications.
Who cannot join
- having a 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 training 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
Ankara
About this study
Hematologic malignancy is a tumor of myeloid or lymphatic cells that affects lymph nodes with the involvement of blood, bone marrow or other organs.There are various treatment options for hematological malignancies ranging from follow-up to single or multiple agent chemotherapy, radiotherapy, immunotherapy and autologous or allogeneic hematopoietic stem cell transplantations (HSCT). The general recommendation for patients is to relax and avoid intense exercise, regardless of the devastating consequences of neglecting physical exercise. Patients also go to relaxation by reducing their activity to avoid fatigue, which leads to loss of muscle strength and endurance. As a consequence of all, fatigue, vomiting, weight loss, anemia, depression, decreased aerobic capacity, muscle weakness, decreased physical function and poor quality of life are observed in HSCT recipients. It has been shown that physical exercises improve oxygen consumption, depression and fatigue, cardiorespiratory fitness, muscle strength and physical well-being in patients with hematologic malignancies who are at stages of various treatments. In literature, effects of upper extremity aerobic exercise training have been investigated in patients with spinal cord injury, neuromuscular diseases, claudication, hypertension, multiple sclerosis, heart failure, paraplegic patients and healthy individuals. Results of these studies has shown that upper extremity aerobic exercise training improves walking distance, increases oxygen pulse, muscle strength and endurance of upper extremity. No study was observed to investigate the effects of upper extremity aerobic exercise training on exercise capacity and quality of life in HSCT recipients, as we know. For this reason, our aim is to investigate the effects of upper extremity aerobic exercise training on exercise capacity and quality of life in HSCT recipients.
Read the detailed description
Minimum 30 allogeneic and autologous HSCT recipients (˃100 days past post-transplant status) will be included. Before and after 6-week upper extremity aerobic exercise training, maximal and submaximal exercise capacity, respiratory and peripheral muscle strength, pulmonary functions, physical activity, dyspnea and fatigue perception, anxiety, depression and quality of life were evaluated. Primary outcome measurements were exercise capacity and quality of life , secondary outcomes were respiratory and peripheral muscle strength, pulmonary functions, physical activity, dyspnea and fatigue perception, anxiety and depression.
- Being tested
- Upper Extremity Aerobic Exercise
- Keywords
- Hematopoietic stem cell transplantation, Aerobic exercise, Quality of Life, Muscle Strength, Depression, exercise capacity, dyspnea, anxiety, fatigue, pulmonary functions
- Medical subject headings
- Depression, Dyspnea, Anxiety Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Extremity Aerobic ExerciseOther
Range of maximal heart rate is being followed by a polar band during supervised session each week.
Aerobic exercise is being trained for 30 min-per/day, 3 days/week, 6 weeks. All sessions are being performed by a physiotherapist at cardiopulmonary rehabilitation department.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group: aerobic exercise | Experimental | The upper extremity aerobic exercise training with an arm ergometer will be performed in the treatment group so that training intensity will be between 60% and 80% of the maximum heart rate, dyspnea perception will be 3-4 according to Modified Borg Scale and fatigue perception will be 5-6 according to Modified Borg Scale, training duration will be a 6-week. Receives: Other: Upper Extremity Aerobic Exercise |
| Control group: deep breathing exercise | No intervention | Deep breathing exercises combinated with arm movements will be given as a home schedule in the control group. Training duration will be a 6-week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional exercise capacity evaluation
Evaluated with 6-minute walking test
Measured: 6-week
Secondary outcomes (9)
pulmonary functions test
Evaluated with spirometer
Measured: 6-week
muscle strength
Evaluated with a hand-held dynamometer for peripheral muscles, mouth pressure device for respiratory muscle strength
Measured: 6-week
cough strength
Evaluated with peak flow meter
Measured: 6-week
physical activity level
Evaluated with a metabolic holter
Measured: 6-week
fatigue severity
Evaluated using Fatigue Severity Scale
Measured: 6-week
anxiety and depression perception
Evaluated using Hospital Anxiety and Depression Scale
Measured: 6-week
dyspnea perception
Evaluated using Modified Medical Research Council Dyspnea scale (MMRC) and Modified Borg Scale
Measured: 6-week
quality of life level
evaluated using QOL using European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)
Measured: 6-week
maximal exercise capacity evaluation
evaluated using Modified Incremental Shuttle Walk Test
Measured: 6-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startApr 2016
- Primary completionAug 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- 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
- Gülşah Barğı, MSc., Study chair, Gazi UniversityMeral Boşnak Güçlü, PhD., Study director, Gazi UniversityZübeyde Nur Özkurt, PhD., Principal investigator, Gazi UniversityMünci Yağcı, PhD., Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007602
- Sponsor's protocol ID
- Gazi-231
- Status last verified
- Feb 2021
- First submitted
- 16 Dec 2016
- Last updated
- 25 Feb 2021
- 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 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upper Extremity Aerobic Exercise Training in Hematopoietic Stem Cell Transplantation Recipients
- ClinicalTrials.gov ID
- NCT03007602
- Acronym / sponsor ID
- Gazi-231
- Keywords
- Hematopoietic stem cell transplantation, Aerobic exercise, Quality of Life, Muscle Strength, Depression, exercise capacity, dyspnea, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 2 Jan 2017 (estimated)
- 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 malignancy is a tumor of myeloid or lymphatic cells that affects lymph nodes with the involvement of blood, bone marrow or other organs.There are various treatment options for hematological malignancies ranging from follow-up to single or multiple agent chemotherapy, radiotherapy, immunotherapy and autologous or allogeneic hematopoietic stem cell transplantations (HSCT). The general recommendation for patients is to relax and avoid intense exercise, regardless of the devastating consequences of neglecting physical exercise. Patients also go to relaxation by reducing their activity to avoid fatigue, which leads to loss of muscle strength and endurance. As a consequence of all, fatigue, vomiting, weight loss, anemia, depression, decreased aerobic capacity, muscle weakness, decreased physical function and poor quality of life are observed in HSCT recipients. It has been shown that physical exercises improve oxygen consumption, depression and fatigue, cardiorespiratory fitness, muscle strength and physical well-being in patients with hematologic malignancies who are at stages of various treatments. In literature, effects of upper extremity aerobic exercise training have been investigated in patients with spinal cord injury, neuromuscular diseases, claudication, hypertension, multiple sclerosis, heart failure, paraplegic patients and healthy individuals. Results of these studies has shown that upper extremity aerobic exercise training improves walking distance, increases oxygen pulse, muscle strength and endurance of upper extremity. No study was observed to investigate the effects of upper extremity aerobic exercise training on exercise capacity and quality of life in HSCT recipients, as we know. For this reason, our aim is to investigate the effects of upper extremity aerobic exercise training on exercise capacity and quality of life in HSCT recipients.
Detailed description
Minimum 30 allogeneic and autologous HSCT recipients (˃100 days past post-transplant status) will be included. Before and after 6-week upper extremity aerobic exercise training, maximal and submaximal exercise capacity, respiratory and peripheral muscle strength, pulmonary functions, physical activity, dyspnea and fatigue perception, anxiety, depression and quality of life were evaluated. Primary outcome measurements were exercise capacity and quality of life , secondary outcomes were respiratory and peripheral muscle strength, pulmonary functions, physical activity, dyspnea and fatigue perception, anxiety and depression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group: aerobic exercise | Experimental | Other: Upper Extremity Aerobic ExerciseThe upper extremity aerobic exercise training with an arm ergometer will be performed in the treatment group so that training intensity will be between 60% and 80% of the maximum heart rate, dyspnea perception will be 3-4 according to Modified Borg Scale and fatigue perception will be 5-6 according to Modified Borg Scale, training duration will be a 6-week. |
| Control group: deep breathing exercise | No intervention | –Deep breathing exercises combinated with arm movements will be given as a home schedule in the control group. Training duration will be a 6-week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- being an hematopoietic stem cell transplantation recipient during the intermediate/late post-transplant phase (>100 days),
- 18-65 years of age
- under standard medications.
Key exclusion criteria (7 listed)
- having a 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 training 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper Extremity Aerobic ExerciseRange of maximal heart rate is being followed by a polar band during supervised session each week. Aerobic exercise is being trained for 30 min-per/day, 3 days/week, 6 weeks. All sessions are being performed by a physiotherapist at cardiopulmonary rehabilitation department. | Other | Treatment group: aerobic exercise |
Primary outcome
functional exercise capacity evaluation
Time frame: 6-week
Evaluated with 6-minute walking test
9 secondary outcomes
pulmonary functions test
Time frame: 6-week
muscle strength
Time frame: 6-week
cough strength
Time frame: 6-week
physical activity level
Time frame: 6-week
fatigue severity
Time frame: 6-week
anxiety and depression perception
Time frame: 6-week
dyspnea perception
Time frame: 6-week
quality of life level
Time frame: 6-week
maximal exercise capacity evaluation
Time frame: 6-week
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 25 Feb 2021.
- 'Best supportive care' has had its day.Link provided by the sponsor.
- Management of bleeding and of invasive procedures in patients with platelet disorders and/or thrombocytopenia: Guidelines of the Italian Society for Haemostasis and Thrombosis (SISET).Link provided by the sponsor.
- Aerobic physical exercise for adult patients with haematological malignancies.Link 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.
Gülşah Barğı, MSc. study chair
Gazi University
Meral Boşnak Güçlü, PhD. study director
Gazi University
Zübeyde Nur Özkurt, PhD. principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Extremity Aerobic Exercise in people with Hematopoietic Stem Cell Transplantation and Aerobic Exercise, 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 25 Feb 2021. 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 evaluation (time frame: 6-week). 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 25 Feb 2021.