Stem Cell TransplantationNCT03699358
Physical Impairments Related to Myeloid and Lymphoid Malignancies
An observational study of Stem Cell Transplantation, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Hematologic malignancies may arise from myeloid and lymphoid blood cells lineages affecting blood, bone marrow and lymph nodes. Accordingly, negative effects of malignancies on body systems vary. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stem Cell Transplantation
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2012to Aug 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients in Bone Marrow Transplantation Unit of University were referred for participation in rehabilitation program as outpatient to Faculty of Health Science of University, Department of Physiotherapy and Rehabilitation, cardiopulmonary rehabilitation unit. Patients diagnosed with hematologic malignancy were recipients who undergone allogeneic-HSCT. Recipients who had myeloid type disorders were included in myeloid group as well as recipients who had lymphoid type disorders were included in lymphoid group. A physiotherapist conducted all measurements in the same day for all recipients individually.
Who may be able to join
- 18-65 years of age,
- being an allogeneic-HSCT recipient who was at minimum 100 days status after transplantation
- receiving optimal standard medical therapy including immunosuppressive agents, antibiotics, supplements and other drugs.
Who cannot join
- having cognitive disorders, orthopedic or neurological disease with a potential to affect assessment of exercise capacity, visual impairments and mucositis which may prevent measurements, comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute respiratory or other infections, acute hemorrhage, low hemoglobin values (≤8 g/L) and low platelet count (≤10.000 mm3).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Health Science Department of PhysioTherapy
Ankara, 06560
About this study
Official title: Does Myeloid or Lymphoid Origin of Hematologic Neoplasm Affect Pulmonary Functions, Muscle Strength, Exercise Capacity, Fatigue and Quality of Life?
Hematologic malignancies may arise from myeloid and lymphoid blood cells lineages affecting blood, bone marrow and lymph nodes. Accordingly, negative effects of malignancies on body systems vary. As known, muscle strength, exercise capacity, fatigue and quality of life deteriorate during allogeneic hematopoietic stem cell transplantation (HSCT). However, impacts of myeloid and lymphoid type disorders on pulmonary functions, muscle strength, exercise capacity, fatigue and quality of life in allogeneic-HSCT who diagnosed with hematologic malignancies. Therefore, current study aimed to comparatively investigate physical impairments between recipients with hematologic malignancies according to myeloid and lymphoid type disorder.
Read the detailed description
Hematologic malignancies affecting blood, bone marrow and lymph nodes comprise neoplasm of either myeloid or lymphoid blood stem cells origin. While a lymphoid stem cell becomes a white blood cell, a myeloid stem cell becomes one of the red blood cells, white blood cells or platelets types. Due to the this reason, defects in myeloid stem cells result in acute and chronic myelogenous leukemia, myelodysplastic syndromes or myeloproliferative diseases, whereas defects in lymphoid stem cells result in lymphomas, lymphocytic leukemias or myeloma. On the other hand, most of these hematologic malignancies are characterized with high rate of morbidity and mortality because of both the nature and various toxic treatments of neoplasm including chemotherapy with multiple agents, corticosteroids and hematopoietic stem cell transplantation (HSCT). Especially after allogeneic-HSCT, recipients experience more impairments in pulmonary functions, respiratory and peripheral muscle strength, exercise capacity, perception of fatigue and quality of life scores which make their lives difficult in terms of actively trying to return to the their life. However, although it has been known that each hematologic disease has a different negative impact on varied body systems or organs after HSCT, little attention has been paid to the comparatively investigation of impacts of myeloid and lymphoid hematological malignancies on pulmonary functions, muscle strength, exercise capacity, fatigue and quality of life in allogeneic-HSCT recipients. Hence, current study aimed to comparatively investigate physical impairments between recipients with hematologic malignancies according to myeloid and lymphoid type disorder.
Recipients undergone allogeneic-HSCT (˃100 days post-HSCT status) were included. Hematologic malignancies were grouped as myeloid and lymphoid. Pulmonary functions (spirometry), peripheral (dynamometer) and respiratory muscle strength (MIP-MEP) (mouth pressure device), exercise capacity (Modified Incremental Shuttle Walk Test (ISWT)), and quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) were evaluated.
- Conditions
- Stem Cell Transplantation
- Keywords
- hematopoietic stem cell transplantation, respiratory function test, respiratory muscles, muscle strength, exercise, walk test, quality of life
- Medical subject headings
- Motor Activity
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 |
|---|---|---|
| Group 1: Myeloid recipients | Patients diagnosed with hematologic malignancy were recipients who undergone allogeneic-HSCT. Recipients were included in the current study and grouped as myeloid and lymphoid according to origin of their diagnosis. Recipients who had myeloid type disorders were included in myeloid group as well as recipients who had lymphoid type disorders were included in lymphoid group. | |
| Group 2: Lymphoid recipients | Patients diagnosed with hematologic malignancy were recipients who undergone allogeneic-HSCT. Recipients were included in the current study and grouped as myeloid and lymphoid according to origin of their diagnosis. Recipients who had myeloid type disorders were included in myeloid group as well as recipients who had lymphoid type disorders were included in lymphoid group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal exercise capacity evaluation
Modified-Incremental Shuttle Walk Test (ISWT) test was used to evaluate maximal exercise capaciity.
Measured: 15-20 minutes
Secondary outcomes (4)
pulmonary function test
This test was evaluated using a spirometry
Measured: 5 minutes
Inspiratory and expiratory muscle strength (MIP, MEP)
Respiratory muscle strength was evaluated with a mouth pressure device
Measured: 5-10 minutes
Quadriceps femoris muscle strength
Peripheral muscle strength was evaluated with a hand-held dynamometer
Measured: 5 minutes
Quality of life level
The Turkish version of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version3.0 (EORTC QLQ-C30) was carried out to the recipients for evaluation of aspects of quality of life impairment which is a valid and reliable questionnaire for patients with cancer in the whole world.Self-administered questionnaire incorporates five functional scales including social functioning subscale, three symptom scales including fatigue subscale, and a global health status as well as several single items. All item scores are transformed to percents (0-100). Higher values represent higher functional/healthy level in functional scales, a higher quality of life level in global health status and increased presence of symptoms in symptom scales.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study startMar 2012
- Primary completionApr 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 57 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, PhD, Study chair, Gazi UniversityMeral Boşnak Güçlü, PhD, Study director, Gazi UniversityGülsan Türköz Sucak, PhD., Principal investigator, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699358
- Sponsor's protocol ID
- GaziUniversity15
- Status last verified
- Jun 2019
- First submitted
- 5 Oct 2018
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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.
Publications
Paul KL. Rehabilitation and exercise considerations in hematologic malignancies. Am J Phys Med Rehabil. 2011 May;90(5 Suppl 1):S88-94. doi: 10.1097/PHM.0b013e31820be055.
PubMed 21765268Bergenthal N, Will A, Streckmann F, Wolkewitz KD, Monsef I, Engert A, Elter T, Skoetz N. Aerobic physical exercise for adult patients with haematological malignancies. Cochrane Database Syst Rev. 2014 Nov 11;(11):CD009075. doi: 10.1002/14651858.CD009075.pub2.
PubMed 25386666Steinberg A, Asher A, Bailey C, Fu JB. The role of physical rehabilitation in stem cell transplantation patients. Support Care Cancer. 2015 Aug;23(8):2447-60. doi: 10.1007/s00520-015-2744-3. Epub 2015 May 14.
PubMed 25971213Bargi G, Bosnak Guclu M, Turkoz Sucak AG. Differences in pulmonary and extra-pulmonary characteristics in severely versus non-severely fatigued recipients of allogeneic hematopoietic stem cell transplantation: a cross-sectional, comparative study. Hematology. 2019 Dec;24(1):112-122. doi: 10.1080/10245332.2018.1526441. Epub 2018 Sep 27.
PubMed 30261831
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Myeloid or Lymphoid Origin of Hematologic Neoplasm Affect Pulmonary Functions, Muscle Strength, Exercise Capacity, Fatigue and Quality of Life?
- ClinicalTrials.gov ID
- NCT03699358
- Acronym / sponsor ID
- GaziUniversity15
- Conditions
- Stem Cell Transplantation
- Keywords
- hematopoietic stem cell transplantation, respiratory function test, respiratory muscles, muscle strength, exercise, walk test, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 9 Oct 2018 (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 may arise from myeloid and lymphoid blood cells lineages affecting blood, bone marrow and lymph nodes. Accordingly, negative effects of malignancies on body systems vary. As known, muscle strength, exercise capacity, fatigue and quality of life deteriorate during allogeneic hematopoietic stem cell transplantation (HSCT). However, impacts of myeloid and lymphoid type disorders on pulmonary functions, muscle strength, exercise capacity, fatigue and quality of life in allogeneic-HSCT who diagnosed with hematologic malignancies. Therefore, current study aimed to comparatively investigate physical impairments between recipients with hematologic malignancies according to myeloid and lymphoid type disorder.
Detailed description
Hematologic malignancies affecting blood, bone marrow and lymph nodes comprise neoplasm of either myeloid or lymphoid blood stem cells origin. While a lymphoid stem cell becomes a white blood cell, a myeloid stem cell becomes one of the red blood cells, white blood cells or platelets types. Due to the this reason, defects in myeloid stem cells result in acute and chronic myelogenous leukemia, myelodysplastic syndromes or myeloproliferative diseases, whereas defects in lymphoid stem cells result in lymphomas, lymphocytic leukemias or myeloma. On the other hand, most of these hematologic malignancies are characterized with high rate of morbidity and mortality because of both the nature and various toxic treatments of neoplasm including chemotherapy with multiple agents, corticosteroids and hematopoietic stem cell transplantation (HSCT). Especially after allogeneic-HSCT, recipients experience more impairments in pulmonary functions, respiratory and peripheral muscle strength, exercise capacity, perception of fatigue and quality of life scores which make their lives difficult in terms of actively trying to return to the their life. However, although it has been known that each hematologic disease has a different negative impact on varied body systems or organs after HSCT, little attention has been paid to the comparatively investigation of impacts of myeloid and lymphoid hematological malignancies on pulmonary functions, muscle strength, exercise capacity, fatigue and quality of life in allogeneic-HSCT recipients. Hence, current study aimed to comparatively investigate physical impairments between recipients with hematologic malignancies according to myeloid and lymphoid type disorder.
Recipients undergone allogeneic-HSCT (˃100 days post-HSCT status) were included. Hematologic malignancies were grouped as myeloid and lymphoid. Pulmonary functions (spirometry), peripheral (dynamometer) and respiratory muscle strength (MIP-MEP) (mouth pressure device), exercise capacity (Modified Incremental Shuttle Walk Test (ISWT)), and quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) were evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Myeloid recipients | – | –Patients diagnosed with hematologic malignancy were recipients who undergone allogeneic-HSCT. Recipients were included in the current study and grouped as myeloid and lymphoid according to origin of their diagnosis. Recipients who had myeloid type disorders were included in myeloid group as well as recipients who had lymphoid type disorders were included in lymphoid group. |
| Group 2: Lymphoid recipients | – | –Patients diagnosed with hematologic malignancy were recipients who undergone allogeneic-HSCT. Recipients were included in the current study and grouped as myeloid and lymphoid according to origin of their diagnosis. Recipients who had myeloid type disorders were included in myeloid group as well as recipients who had lymphoid type disorders were included in lymphoid group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in Bone Marrow Transplantation Unit of University were referred for participation in rehabilitation program as outpatient to Faculty of Health Science of University, Department of Physiotherapy and Rehabilitation, cardiopulmonary rehabilitation unit. Patients diagnosed with hematologic malignancy were recipients who undergone allogeneic-HSCT. Recipients who had myeloid type disorders were included in myeloid group as well as recipients who had lymphoid type disorders were included in lymphoid group. A physiotherapist conducted all measurements in the same day for all recipients individually.
Key inclusion criteria (3 listed)
- 18-65 years of age,
- being an allogeneic-HSCT recipient who was at minimum 100 days status after transplantation
- receiving optimal standard medical therapy including immunosuppressive agents, antibiotics, supplements and other drugs.
Key exclusion criteria (1 listed)
- having cognitive disorders, orthopedic or neurological disease with a potential to affect assessment of exercise capacity, visual impairments and mucositis which may prevent measurements, comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute respiratory or other infections, acute hemorrhage, low hemoglobin values (≤8 g/L) and low platelet count (≤10.000 mm3).
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
Maximal exercise capacity evaluation
Time frame: 15-20 minutes
Modified-Incremental Shuttle Walk Test (ISWT) test was used to evaluate maximal exercise capaciity.
4 secondary outcomes
pulmonary function test
Time frame: 5 minutes
Inspiratory and expiratory muscle strength (MIP, MEP)
Time frame: 5-10 minutes
Quadriceps femoris muscle strength
Time frame: 5 minutes
Quality of life level
Time frame: 2 minutes
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 1 Jul 2019.
- Background: PubMed 21765268Paul KL. Rehabilitation and exercise considerations in hematologic malignancies. Am J Phys Med Rehabil. 2011 May;90(5 Suppl 1):S88-94. doi: 10.1097/PHM.0b013e31820be055.
- Background: PubMed 25386666Bergenthal N, Will A, Streckmann F, Wolkewitz KD, Monsef I, Engert A, Elter T, Skoetz N. Aerobic physical exercise for adult patients with haematological malignancies. Cochrane Database Syst Rev. 2014 Nov 11;(11):CD009075. doi: 10.1002/14651858.CD009075.pub2.
- Background: PubMed 25971213Steinberg A, Asher A, Bailey C, Fu JB. The role of physical rehabilitation in stem cell transplantation patients. Support Care Cancer. 2015 Aug;23(8):2447-60. doi: 10.1007/s00520-015-2744-3. Epub 2015 May 14.
- Background: PubMed 30261831Bargi G, Bosnak Guclu M, Turkoz Sucak AG. Differences in pulmonary and extra-pulmonary characteristics in severely versus non-severely fatigued recipients of allogeneic hematopoietic stem cell transplantation: a cross-sectional, comparative study. Hematology. 2019 Dec;24(1):112-122. doi: 10.1080/10245332.2018.1526441. Epub 2018 Sep 27.
- 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.
Related trials for Stem Cell Transplantation
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
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, PhD study chair
Gazi University
Meral Boşnak Güçlü, PhD study director
Gazi University
Gülsan Türköz Sucak, PhD. principal investigator
Bahçeşehir University
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 Stem Cell Transplantation, 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 1 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 1 Jul 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?
Maximal exercise capacity evaluation (time frame: 15-20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03699358, which also lists 4 linked publications.
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 1 Jul 2019.