Stem Cell TransplantationNCT03448627
Physical Impairments in Allogeneic-HSCT
An observational study of Stem Cell Transplantation, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Pulmonary functions, exercise capacity and muscle strength deteriorate in survived hematopoietic stem cell transplantation (HSCT) recipients due to toxic effects of chemotherapy, radiotherapy, conditioning regimens and/or corticosteroid use before HSCT, prolonged stay of recipients in rooms with laminar airflow and… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stem Cell Transplantation
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2012to Dec 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 66 recipients underwent allogeneic HSCT who were at minimum 100 days status post-transplantation compared with 50 healthy individuals. All recipients transplanted at the Bone Marrow Transplantation Unit of University Faculty of Medicine. All measurements were done by a physiotherapist at Cardiopulmonary Unit of University Faculty of Health Science Department of Physiotherapy and Rehabilitation. Demographic and clinical characteristics of all participants were recorded. Study was planned as retrospective, cross sectional and approved by the local Ethics Committee. Informed consent was obtained from all individual participants included in the study.
Who may be able to join
- between ages of 18 and 70
- under standard medical treatment
- underwent allogeneic HSCT who were at minimum 100 days status post-transplantation
- being individuals without known and diagnosed any chronic diseases
- not actively smoking
- their cigarette exposure is not greater than 5 pack*year.
Who cannot join
- having cognitive disorder, orthopedic or neurological disease with a potential to affect assessment of maximal exercise capacity,
- having comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute respiratory or other infections,
- having problems like visual and mucositis which may prevent measurements,
- acute hemorrhage anywhere in the body,
- hemoglobin value less than 8 g/L and platelet count less than 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, 06010
About this study
Official title: Physiological Responses to Maximal Exercise Capacity and Muscle Strength in Survived Hematopoietic Stem Cell Transplantation Recipients
Pulmonary functions, exercise capacity and muscle strength deteriorate in survived hematopoietic stem cell transplantation (HSCT) recipients due to toxic effects of chemotherapy, radiotherapy, conditioning regimens and/or corticosteroid use before HSCT, prolonged stay of recipients in rooms with laminar airflow and strict infection control rules during process of HSCT. There are also limited numbers of studies demonstrated pulmonary function abnormalities, decreased maximal exercise capacity, respiratory and peripheral muscle weakness in recipients. Current study was planned since no study compared pulmonary functions, maximal exercise capacity, respiratory and peripheral muscle strength between recipients and healthy individuals in the literature.
Read the detailed description
Treatments of hematologic malignancies consist of chemotherapy, radiotherapy, surgery, medical treatment, supportive care and/or hematopoietic stem cell transplantation (HSCT) which is resulted in early or late adverse effects on body systems, tissues and organs. Physical deconditioning is also observed in patients with hematologic malignancies because of reasons such as neurotoxic and pulmonary toxic effects of long term these anticancer treatments, immobilization, recommendation of resting and avoiding intense exercise, nutrition problems, severe anemia and thrombocytopenia etc. For these reasons, normal physical activities may not be kept on by patients which induces decreased physical performance.
The HSCT provides longer survival with standard treatments for patients with hematological malignancies while it increases risk of HSCT-related toxicity, complications and even mortality. Infectious and non-infectious pulmonary complications occur in about 60% of HSCT recipients and intensive-care unit support is also required in one-third of recipients for these reasons. Restrictive lung disease prior to allogeneic HSCT is related to early respiratory failure, non-relapse mortality and respiratory muscle weakness in post transplantation period. Therefore pulmonary restriction is considered as a risk factor for complications or failure of HSCT. Moreover it is known that carbon monoxide diffusing capacity of lungs which is the most common abnormality seen in pulmonary function test, respiratory muscle strength and functional exercise capacity are reduced in the majority of patients before HSCT. In addition to muscle weakness and decreased exercise capacity at prior to HSCT, patients experience more reduction in both inspiratory and expiratory muscles and exercise capacity after HSCT. Unfortunately, exercise capacity and peripheral muscle strength are decreased in HSCT recipients in spite of doing regular and planned exercise during acute process of HSCT. The average reduction in functional exercise capacity of recipients is 48 m. As shown in the literature, limited number of study has used evaluation of maximal exercise capacity with Modified-Incremental Shuttle Walk Test (ISWT) in HSCT patients and recipients. On the other hand, it has been reported that ISWT is a reliable test and has no adverse event or side effects for HSCT recipients in these studies, as well. Despite the fact that there is no negative feedback related to using of this test in recipients, no study comprehensively demonstrated influence of HSCT on maximal exercise capacity.
Impairments in pulmonary functions, respiratory muscle strength and maximal exercise capacity have been demonstrated in limited number of studies. Moreover, there is no study compared pulmonary functions, respiratory muscle strength and maximal exercise capacity between HSCT recipients and healthy individuals. Therefore investigators aimed to compare aforementioned outcomes between recipients and healthy individuals.
- Conditions
- Stem Cell Transplantation
- Keywords
- stem cell transplantation, Pulmonary Functions, muscle strength, exercise capacity
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: HSCT recipients | Pulmonary functions [spirometry], maximal exercise capacity [Modified-Incremental Shuttle Walk Test (ISWT)], inspiratory and expiratory muscle strength (MIP and MEP, respectively) [mouth pressure device] and peripheral muscle strength [hand-held dynamometer] were evaluated in allogeneic HSCT recipients (n=66).Vital signs, dyspnea and fatigue perception [Modified Borg Scale] were recorded as pre-post measurements of Modified-ISWT. | |
| Group 2: healthy individuals | Healthy individuals (n=50) were selected from individuals without known and diagnosed any chronic diseases. Similar measurements were applicated in healthy individuals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified-Incremental Shuttle Walk Test (ISWT)
This test was used to evaluate maximal exercise capacity
Measured: 15-20 minutes
Secondary outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study startMar 2012
- Primary completionNov 2014
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Stem Cell TransplantationStudies 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
- Prospective
- Enrolment
- 122 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, Principal investigator, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448627
- Sponsor's protocol ID
- GaziUniversity6
- Status last verified
- Apr 2019
- First submitted
- 22 Feb 2018
- Last updated
- 16 Apr 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
Kovalszki A, Schumaker GL, Klein A, Terrin N, White AC. Reduced respiratory and skeletal muscle strength in survivors of sibling or unrelated donor hematopoietic stem cell transplantation. Bone Marrow Transplant. 2008 Jun;41(11):965-9. doi: 10.1038/bmt.2008.15. Epub 2008 Feb 11.
PubMed 18264142Morishita S, Kaida K, Yamauchi S, Sota K, Ishii S, Ikegame K, Kodama N, Ogawa H, Domen K. Relationship between corticosteroid dose and declines in physical function among allogeneic hematopoietic stem cell transplantation patients. Support Care Cancer. 2013 Aug;21(8):2161-9. doi: 10.1007/s00520-013-1778-7. Epub 2013 Mar 9.
PubMed 23475197Knols RH, de Bruin ED, Uebelhart D, Aufdemkampe G, Schanz U, Stenner-Liewen F, Hitz F, Taverna C, Aaronson NK. Effects of an outpatient physical exercise program on hematopoietic stem-cell transplantation recipients: a randomized clinical trial. Bone Marrow Transplant. 2011 Sep;46(9):1245-55. doi: 10.1038/bmt.2010.288. Epub 2010 Dec 6.
PubMed 21132025Shelton ML, Lee JQ, Morris GS, Massey PR, Kendall DG, Munsell MF, Anderson KO, Simmonds MJ, Giralt SA. A randomized control trial of a supervised versus a self-directed exercise program for allogeneic stem cell transplant patients. Psychooncology. 2009 Apr;18(4):353-9. doi: 10.1002/pon.1505.
PubMed 19117328Morishita S, Kaida K, Yamauchi S, Wakasugi T, Ikegame K, Ogawa H, Domen K. Relationship of physical activity with physical function and health-related quality of life in patients having undergone allogeneic haematopoietic stem-cell transplantation. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12669. Epub 2017 Feb 21.
PubMed 28220548Bargi G, Guclu MB, Aribas Z, Aki SZ, Sucak GT. Inspiratory muscle training in allogeneic hematopoietic stem cell transplantation recipients: a randomized controlled trial. Support Care Cancer. 2016 Feb;24(2):647-659. doi: 10.1007/s00520-015-2825-3. Epub 2015 Jul 2.
PubMed 26135532Bird L, Arthur A, Niblock T, Stone R, Watson L, Cox K. Rehabilitation programme after stem cell transplantation: randomized controlled trial. J Adv Nurs. 2010 Mar;66(3):607-15. doi: 10.1111/j.1365-2648.2009.05232.x.
PubMed 20423395
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Responses to Maximal Exercise Capacity and Muscle Strength in Survived Hematopoietic Stem Cell Transplantation Recipients
- ClinicalTrials.gov ID
- NCT03448627
- Acronym / sponsor ID
- GaziUniversity6
- Conditions
- Stem Cell Transplantation
- Keywords
- stem cell transplantation, Pulmonary Functions, muscle strength, exercise capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 28 Feb 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.
Pulmonary functions, exercise capacity and muscle strength deteriorate in survived hematopoietic stem cell transplantation (HSCT) recipients due to toxic effects of chemotherapy, radiotherapy, conditioning regimens and/or corticosteroid use before HSCT, prolonged stay of recipients in rooms with laminar airflow and strict infection control rules during process of HSCT. There are also limited numbers of studies demonstrated pulmonary function abnormalities, decreased maximal exercise capacity, respiratory and peripheral muscle weakness in recipients. Current study was planned since no study compared pulmonary functions, maximal exercise capacity, respiratory and peripheral muscle strength between recipients and healthy individuals in the literature.
Detailed description
Treatments of hematologic malignancies consist of chemotherapy, radiotherapy, surgery, medical treatment, supportive care and/or hematopoietic stem cell transplantation (HSCT) which is resulted in early or late adverse effects on body systems, tissues and organs. Physical deconditioning is also observed in patients with hematologic malignancies because of reasons such as neurotoxic and pulmonary toxic effects of long term these anticancer treatments, immobilization, recommendation of resting and avoiding intense exercise, nutrition problems, severe anemia and thrombocytopenia etc. For these reasons, normal physical activities may not be kept on by patients which induces decreased physical performance.
The HSCT provides longer survival with standard treatments for patients with hematological malignancies while it increases risk of HSCT-related toxicity, complications and even mortality. Infectious and non-infectious pulmonary complications occur in about 60% of HSCT recipients and intensive-care unit support is also required in one-third of recipients for these reasons. Restrictive lung disease prior to allogeneic HSCT is related to early respiratory failure, non-relapse mortality and respiratory muscle weakness in post transplantation period. Therefore pulmonary restriction is considered as a risk factor for complications or failure of HSCT. Moreover it is known that carbon monoxide diffusing capacity of lungs which is the most common abnormality seen in pulmonary function test, respiratory muscle strength and functional exercise capacity are reduced in the majority of patients before HSCT. In addition to muscle weakness and decreased exercise capacity at prior to HSCT, patients experience more reduction in both inspiratory and expiratory muscles and exercise capacity after HSCT. Unfortunately, exercise capacity and peripheral muscle strength are decreased in HSCT recipients in spite of doing regular and planned exercise during acute process of HSCT. The average reduction in functional exercise capacity of recipients is 48 m. As shown in the literature, limited number of study has used evaluation of maximal exercise capacity with Modified-Incremental Shuttle Walk Test (ISWT) in HSCT patients and recipients. On the other hand, it has been reported that ISWT is a reliable test and has no adverse event or side effects for HSCT recipients in these studies, as well. Despite the fact that there is no negative feedback related to using of this test in recipients, no study comprehensively demonstrated influence of HSCT on maximal exercise capacity.
Impairments in pulmonary functions, respiratory muscle strength and maximal exercise capacity have been demonstrated in limited number of studies. Moreover, there is no study compared pulmonary functions, respiratory muscle strength and maximal exercise capacity between HSCT recipients and healthy individuals. Therefore investigators aimed to compare aforementioned outcomes between recipients and healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: HSCT recipients | – | –Pulmonary functions [spirometry], maximal exercise capacity [Modified-Incremental Shuttle Walk Test (ISWT)], inspiratory and expiratory muscle strength (MIP and MEP, respectively) [mouth pressure device] and peripheral muscle strength [hand-held dynamometer] were evaluated in allogeneic HSCT recipients (n=66).Vital signs, dyspnea and fatigue perception [Modified Borg Scale] were recorded as pre-post measurements of Modified-ISWT. |
| Group 2: healthy individuals | – | –Healthy individuals (n=50) were selected from individuals without known and diagnosed any chronic diseases. Similar measurements were applicated in healthy individuals. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 66 recipients underwent allogeneic HSCT who were at minimum 100 days status post-transplantation compared with 50 healthy individuals. All recipients transplanted at the Bone Marrow Transplantation Unit of University Faculty of Medicine. All measurements were done by a physiotherapist at Cardiopulmonary Unit of University Faculty of Health Science Department of Physiotherapy and Rehabilitation. Demographic and clinical characteristics of all participants were recorded. Study was planned as retrospective, cross sectional and approved by the local Ethics Committee. Informed consent was obtained from all individual participants included in the study.
Key inclusion criteria (6 listed)
- between ages of 18 and 70
- under standard medical treatment
- underwent allogeneic HSCT who were at minimum 100 days status post-transplantation
- being individuals without known and diagnosed any chronic diseases
- not actively smoking
Key exclusion criteria (5 listed)
- having cognitive disorder, orthopedic or neurological disease with a potential to affect assessment of maximal exercise capacity,
- having comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute respiratory or other infections,
- having problems like visual and mucositis which may prevent measurements,
- acute hemorrhage anywhere in the body,
- hemoglobin value less than 8 g/L and platelet count less than 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
Modified-Incremental Shuttle Walk Test (ISWT)
Time frame: 15-20 minutes
This test was used to evaluate maximal exercise capacity
3 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
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 16 Apr 2019.
- Results publication: PubMed 18264142Kovalszki A, Schumaker GL, Klein A, Terrin N, White AC. Reduced respiratory and skeletal muscle strength in survivors of sibling or unrelated donor hematopoietic stem cell transplantation. Bone Marrow Transplant. 2008 Jun;41(11):965-9. doi: 10.1038/bmt.2008.15. Epub 2008 Feb 11.
- Results publication: PubMed 23475197Morishita S, Kaida K, Yamauchi S, Sota K, Ishii S, Ikegame K, Kodama N, Ogawa H, Domen K. Relationship between corticosteroid dose and declines in physical function among allogeneic hematopoietic stem cell transplantation patients. Support Care Cancer. 2013 Aug;21(8):2161-9. doi: 10.1007/s00520-013-1778-7. Epub 2013 Mar 9.
- Results publication: PubMed 21132025Knols RH, de Bruin ED, Uebelhart D, Aufdemkampe G, Schanz U, Stenner-Liewen F, Hitz F, Taverna C, Aaronson NK. Effects of an outpatient physical exercise program on hematopoietic stem-cell transplantation recipients: a randomized clinical trial. Bone Marrow Transplant. 2011 Sep;46(9):1245-55. doi: 10.1038/bmt.2010.288. Epub 2010 Dec 6.
- Results publication: PubMed 19117328Shelton ML, Lee JQ, Morris GS, Massey PR, Kendall DG, Munsell MF, Anderson KO, Simmonds MJ, Giralt SA. A randomized control trial of a supervised versus a self-directed exercise program for allogeneic stem cell transplant patients. Psychooncology. 2009 Apr;18(4):353-9. doi: 10.1002/pon.1505.
- Results publication: PubMed 28220548Morishita S, Kaida K, Yamauchi S, Wakasugi T, Ikegame K, Ogawa H, Domen K. Relationship of physical activity with physical function and health-related quality of life in patients having undergone allogeneic haematopoietic stem-cell transplantation. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12669. Epub 2017 Feb 21.
- Results publication: PubMed 26135532Bargi G, Guclu MB, Aribas Z, Aki SZ, Sucak GT. Inspiratory muscle training in allogeneic hematopoietic stem cell transplantation recipients: a randomized controlled trial. Support Care Cancer. 2016 Feb;24(2):647-659. doi: 10.1007/s00520-015-2825-3. Epub 2015 Jul 2.
- Results publication: PubMed 20423395Bird L, Arthur A, Niblock T, Stone R, Watson L, Cox K. Rehabilitation programme after stem cell transplantation: randomized controlled trial. J Adv Nurs. 2010 Mar;66(3):607-15. doi: 10.1111/j.1365-2648.2009.05232.x.
- 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, PhD study chair
Gazi University
Meral Boşnak Güçlü, PhD study director
Gazi University
Gülsan Türköz Sucak 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 6 inclusion and 5 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 16 Apr 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?
Modified-Incremental Shuttle Walk Test (ISWT) (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 NCT03448627, which also lists 7 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 16 Apr 2019.