Hematopoietic Stem Cell TransplantationNCT03915210
Physical Inactivity in Candidates of HSCT
An observational study of Hematopoietic Stem Cell Transplantation, run by Gazi University.
Trial summary
Decreased number of steps and poorer quality of life are prevalently observed among candidates of hematopoietic stem cell transplantation (HSCT). However, impairments in other aspects of physical activity measurement including energy expenditure, physical activity duration, metabolic equivalents of daily task (METs)… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2014
- 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: Patients were previously diagnosed with a hematological malignancy and determined to be a candidate for allogeneic-HSCT who were orientated from Bone Marrow Transplantation Unit for rehabilitation program. Healthy individuals were recruited from staff in the university and their healthy relatives.
Who may be able to join
- being aged between 18 and 65 years, being a candidate for either allogeneic or autologous HSCT before the start of conditioning regimen who were orientated from Bone Marrow Transplantation Unit,
- having a diagnosis with a hematologic malignancy,
- being clinically stabile,
- being functionally mobile
- receiving optimal standard medical therapy including antibiotics, supplements and other drugs.
- being eager to participate to the study
- being aged between 18 and 65 years,
Who cannot join
- having cooperation problems, having orthopedic or neurological disease with a potential to limit daily walking,
- having comorbidities such as chronic obstructive pulmonary disease, cardiac diseases, acute infections and/or active hemorrhage (with hemoglobin values ≤8 g/L and platelet count ≤10.000 mm3)
- having any diagnosis of chronic diseases
- being current smokers
- being ex-smokers (≥10 pack*years)
About this study
Official title: Physical Activity Level, Pulmonary Functions and Quality of Life in Candidates of Hematopoietic Stem Cell Transplantation and Healthy Individuals: a Cross-sectional Study
Decreased number of steps and poorer quality of life are prevalently observed among candidates of hematopoietic stem cell transplantation (HSCT). However, impairments in other aspects of physical activity measurement including energy expenditure, physical activity duration, metabolic equivalents of daily task (METs) and lying down duration are still unknown in candidates based on comparison with healthy individuals, which was therefore aimed to investigate in current study.
Read the detailed description
In recent years, hematopoietic stem cell transplantation (HSCT) has been largely used to cure not only many hematologic malignancies but also autoimmune diseases and even genetic diseases. Advances in the HSCT and other cancer treatment approaches including supportive care practices provide patients better survival time nowadays. However, as life expectancy for recipients is increasing up to 85% for being alive 10 years after HSCT, post-HSCT complications are concurrently increasing. After HSCT, recipients may suffer from many infectious complications, cytopenia, immunosuppression, graft versus host disease, a lot of organ involvements and even secondary malignancies. In addition, they are also exposed to immobility condition, physical inactivity, depressive symptoms, psychosocial distress, fatigue, and complications of musculoskeletal, respiratory and cardiovascular systems rely on mostly treatments and treatment related with complications all of which have a negative impact on the survival, physical functions and quality of life of recipients. Hence, the guidelines recommend to all recipients both routine evaluations of clinical and cardiovascular risk factors, and also complying with healthy life style including doing regular physical activity and exercises.
On the other hand, chemotherapy, radiation therapy and further conditioning regimens are required to exterminate the abnormally proliferating cancer cells in patients with hematologic malignancies before HSCT, which also leads to pre-HSCT complications. These complications are observed as physical inactivity, abnormal pulmonary functions, muscle weakness, decreased exercise capacity, evident fatigue, psychological mood disorders and poorer quality of life in these patients until HSCT. Should immobility and physical inactivity extend, the patients may need to respiratory support including oxygen supply, noninvasive or invasive mechanic ventilation. As previously shown, these impairments especially physical inactivity have even existed in patients with hematologic malignancies at the period of pre-diagnosis and early diagnosis. While 33.8% of patients (n=438) could achieve the daily/weekly exercise criteria of guidelines during the time of pre-diagnosis, only 6.5% of patients could perform physical activity during anticancer treatments. In that study, physical activity level was evaluated using a questionnaire, and the patients meeting public health exercise guidelines have reported higher quality of life level. According to results of another study with higher sample size (n=3060), 1392 (46%) of patients are physically active based on their responses to questions at the pre-diagnosis period. However, the most striking result to emerge from the data in 2018 is that these active patients have considerably higher survival rates rather than insufficiently active patients. As demonstrated in 2014 (n=29), 61% of patients with early diagnosis meet the physical activity guidelines, and patients walk about 6.149 steps/d before the start of chemotherapy which was evaluated via a tri-axial accelerometer. As known, although patients have survived after HSCT, these problems have not meliorated in survivors over a long time after HSCT. Therefore, guidelines recommend that the patients should be oriented for rehabilitation in order to maximize muscle strength, functional mobility and quality of life of patients before the patients are subject to the process of HSCT.
Evaluation and counseling of physical activity have become one of the most challenging topics recently; however, there is confusion in the meaning and usage of this term. Original definition of physical activity is "Physical activity is defined as any bodily movement produced by skeletal muscles that results in energy expenditure. Physical activity in daily life can be categorized into occupational, sports, conditioning, household, or other activities. Exercise is a subset of physical activity that is planned, structured, and repetitive and has as a final or an intermediate objective the improvement or maintenance of physical fitness.". In the literature, researchers have mostly tend to only one aspect of physical activity measurement in candidates of HSCT which is either steps count or estimation of physical activity intensity as regard to metabolic equivalent of daily task (MET). In fact, reason of this situation was that less objective tools such as questionnaire, questions, and pedometers were used to evaluate physical activity level in candidates. There is just a few studies used an objective device like triaxial accelerometer in the literature.
Physical inactivity as a cardiovascular risk factor is related with higher risks of cardiovascular diseases and complications after HSCT. Therefore, it is important to assess detailed physical activity along with its all aspects including energy expenditure, number of steps, activity types and durations in candidates of HSCT. However, impairments in energy expenditure, physical activity duration, metabolic equivalents of daily task (METs) and lying down duration are still unknown in candidates versus healthy individuals who are age and gender matched counterparts of candidates. Hence, it was aimed to compare physical activity parameters, pulmonary functions and quality of life scores of candidates with healthy individuals in the current study.
- Conditions
- Hematopoietic Stem Cell Transplantation
- Keywords
- Energy metabolism, Exercise, respiratory function test, quality of life, leisure activities, hematopoietic stem cell transplantation
- 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 |
|---|---|---|
| Candidates of HSCT | Physical activity level using a metabolic holter device, dynamic lung volumes (FEV1, FVC, FEV1/FVC, PEF, FEF25-75%) using a spirometer and quality of life using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version 3.0 were objectively evaluated. | |
| Healthy individuals | Physical activity level using a metabolic holter device, dynamic lung volumes (FEV1, FVC, FEV1/FVC, PEF, FEF25-75%) using a spirometer and quality of life using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version 3.0 were objectively evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity measurement
Physical activity levels of all participants were assessed with a metabolic holter device.
Measured: during a total of 48 hours
Secondary outcomes (2)
Evaluation of dynamic lung volumes
To assess dynamic lung volumes involving forced vital capacity (FVC), forced expiratory volume in one second (FEV1), forced expiratory volume in one second/forced vital capacity (FEV1/FVC), peak expiratory flow (PEF) and forced expiratory flow at 25%-75% (FEF25-75%), a spirometer was used. Guidelines were taken reference for this measurement. These values were recorded as percentages of predicted values.
Measured: 5 minutes
General quality of life assesment: European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)
European Organization for Research and Treatment of Cancer QOL Questionnaire C30 version3.0 was used to evaluate quality of life impairment. This is a self-administered questionnaire which consists of five functional subscales along with a social functioning subscale, three symptom subscales with also a fatigue subscale, a global health status subscale, and several single items. All item scores are converted to values from 0 to 100. Higher values show higher health levels in functional and social functioning subscales, a higher quality of life level in global health status subscale, and increased presence of symptoms in both symptom and fatigue subscales.
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 posted16 Apr 2019
- Study startJan 2012
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 94 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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915210
- Sponsor's protocol ID
- GaziUniversity18
- Status last verified
- Oct 2020
- First submitted
- 11 Apr 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Copelan EA. Hematopoietic stem-cell transplantation. N Engl J Med. 2006 Apr 27;354(17):1813-26. doi: 10.1056/NEJMra052638. No abstract available.
PubMed 16641398Paudel N, Schulze D, Gentzler RD, Evens AM, Helenowski I, Dillehay G, Frankfurt O, Mehta J, Donnelly ED, Gordon LI, Winter JN, Mittal BB. Patterns of Failure and Survival Outcomes after Total Lymphoid Irradiation and High-Dose Chemotherapy with Autologous Stem Cell Transplantation for Relapsed or Refractory Classical Hodgkin Lymphoma. Int J Radiat Oncol Biol Phys. 2019 Jun 1;104(2):436-446. doi: 10.1016/j.ijrobp.2019.02.007. Epub 2019 Feb 11.
PubMed 30763660Mohammed J, Smith SR, Burns L, Basak G, Aljurf M, Savani BN, Schoemans H, Peric Z, Chaudhri NA, Chigbo N, Alfred A, Bakhsh H, Salooja N, Chris Chim A, Hashmi SK. Role of Physical Therapy before and after Hematopoietic Stem Cell Transplantation: White Paper Report. Biol Blood Marrow Transplant. 2019 Jun;25(6):e191-e198. doi: 10.1016/j.bbmt.2019.01.018. Epub 2019 Jan 15.
PubMed 30658224Wingard JR, Majhail NS, Brazauskas R, Wang Z, Sobocinski KA, Jacobsohn D, Sorror ML, Horowitz MM, Bolwell B, Rizzo JD, Socie G. Long-term survival and late deaths after allogeneic hematopoietic cell transplantation. J Clin Oncol. 2011 Jun 1;29(16):2230-9. doi: 10.1200/JCO.2010.33.7212. Epub 2011 Apr 4.
PubMed 21464398Majhail NS, Rizzo JD, Lee SJ, Aljurf M, Atsuta Y, Bonfim C, Burns LJ, Chaudhri N, Davies S, Okamoto S, Seber A, Socie G, Szer J, Van Lint MT, Wingard JR, Tichelli A; Center for International Blood and Marrow Transplant Research (CIBMTR); American Society for Blood and Marrow Transplantation (ASBMT); European Group for Blood and Marrow Transplantation (EBMT); Asia-Pacific Blood and Marrow Transplantation Group (APBMT); Bone Marrow Transplantation Society of Australia and New Zeland (BMTSANZ); East Mediterrnean Blood and Marrow Transplantation Group (EMBMT); Sociedale Brasileira de Transplante de Medula Ossea (SBTMO). [Recommended screening and preventive practices for long-term survivors after hematopoietic cell transplantation]. Rinsho Ketsueki. 2014 Jun;55(6):607-32. Japanese.
PubMed 24975331Vermaete N, Wolter P, Verhoef G, Gosselink R. Physical activity and physical fitness in lymphoma patients before, during, and after chemotherapy: a prospective longitudinal study. Ann Hematol. 2014 Mar;93(3):411-24. doi: 10.1007/s00277-013-1881-3. Epub 2013 Aug 21.
PubMed 23963412Hung YC, Bauer J, Horsley P, Waterhouse M, Bashford J, Isenring E. Changes in nutritional status, body composition, quality of life, and physical activity levels of cancer patients undergoing autologous peripheral blood stem cell transplantation. Support Care Cancer. 2013 Jun;21(6):1579-86. doi: 10.1007/s00520-012-1698-y. Epub 2013 Jan 10.
PubMed 23306934White AC, Terrin N, Miller KB, Ryan HF. Impaired respiratory and skeletal muscle strength in patients prior to hematopoietic stem-cell transplantation. Chest. 2005 Jul;128(1):145-52. doi: 10.1378/chest.128.1.145.
PubMed 16002928Morishita 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 28220548Morishita S, Kaida K, Tanaka T, Itani Y, Ikegame K, Okada M, Ishii S, Kodama N, Ogawa H, Domen K. Prevalence of sarcopenia and relevance of body composition, physiological function, fatigue, and health-related quality of life in patients before allogeneic hematopoietic stem cell transplantation. Support Care Cancer. 2012 Dec;20(12):3161-8. doi: 10.1007/s00520-012-1460-5. Epub 2012 Apr 12.
PubMed 22526152
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Level, Pulmonary Functions and Quality of Life in Candidates of Hematopoietic Stem Cell Transplantation and Healthy Individuals: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03915210
- Acronym / sponsor ID
- GaziUniversity18
- Conditions
- Hematopoietic Stem Cell Transplantation
- Keywords
- Energy metabolism, Exercise, respiratory function test, quality of life, leisure activities, hematopoietic stem cell transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Apr 2019 (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.
Decreased number of steps and poorer quality of life are prevalently observed among candidates of hematopoietic stem cell transplantation (HSCT). However, impairments in other aspects of physical activity measurement including energy expenditure, physical activity duration, metabolic equivalents of daily task (METs) and lying down duration are still unknown in candidates based on comparison with healthy individuals, which was therefore aimed to investigate in current study.
Detailed description
In recent years, hematopoietic stem cell transplantation (HSCT) has been largely used to cure not only many hematologic malignancies but also autoimmune diseases and even genetic diseases. Advances in the HSCT and other cancer treatment approaches including supportive care practices provide patients better survival time nowadays. However, as life expectancy for recipients is increasing up to 85% for being alive 10 years after HSCT, post-HSCT complications are concurrently increasing. After HSCT, recipients may suffer from many infectious complications, cytopenia, immunosuppression, graft versus host disease, a lot of organ involvements and even secondary malignancies. In addition, they are also exposed to immobility condition, physical inactivity, depressive symptoms, psychosocial distress, fatigue, and complications of musculoskeletal, respiratory and cardiovascular systems rely on mostly treatments and treatment related with complications all of which have a negative impact on the survival, physical functions and quality of life of recipients. Hence, the guidelines recommend to all recipients both routine evaluations of clinical and cardiovascular risk factors, and also complying with healthy life style including doing regular physical activity and exercises.
On the other hand, chemotherapy, radiation therapy and further conditioning regimens are required to exterminate the abnormally proliferating cancer cells in patients with hematologic malignancies before HSCT, which also leads to pre-HSCT complications. These complications are observed as physical inactivity, abnormal pulmonary functions, muscle weakness, decreased exercise capacity, evident fatigue, psychological mood disorders and poorer quality of life in these patients until HSCT. Should immobility and physical inactivity extend, the patients may need to respiratory support including oxygen supply, noninvasive or invasive mechanic ventilation. As previously shown, these impairments especially physical inactivity have even existed in patients with hematologic malignancies at the period of pre-diagnosis and early diagnosis. While 33.8% of patients (n=438) could achieve the daily/weekly exercise criteria of guidelines during the time of pre-diagnosis, only 6.5% of patients could perform physical activity during anticancer treatments. In that study, physical activity level was evaluated using a questionnaire, and the patients meeting public health exercise guidelines have reported higher quality of life level. According to results of another study with higher sample size (n=3060), 1392 (46%) of patients are physically active based on their responses to questions at the pre-diagnosis period. However, the most striking result to emerge from the data in 2018 is that these active patients have considerably higher survival rates rather than insufficiently active patients. As demonstrated in 2014 (n=29), 61% of patients with early diagnosis meet the physical activity guidelines, and patients walk about 6.149 steps/d before the start of chemotherapy which was evaluated via a tri-axial accelerometer. As known, although patients have survived after HSCT, these problems have not meliorated in survivors over a long time after HSCT. Therefore, guidelines recommend that the patients should be oriented for rehabilitation in order to maximize muscle strength, functional mobility and quality of life of patients before the patients are subject to the process of HSCT.
Evaluation and counseling of physical activity have become one of the most challenging topics recently; however, there is confusion in the meaning and usage of this term. Original definition of physical activity is "Physical activity is defined as any bodily movement produced by skeletal muscles that results in energy expenditure. Physical activity in daily life can be categorized into occupational, sports, conditioning, household, or other activities. Exercise is a subset of physical activity that is planned, structured, and repetitive and has as a final or an intermediate objective the improvement or maintenance of physical fitness.". In the literature, researchers have mostly tend to only one aspect of physical activity measurement in candidates of HSCT which is either steps count or estimation of physical activity intensity as regard to metabolic equivalent of daily task (MET). In fact, reason of this situation was that less objective tools such as questionnaire, questions, and pedometers were used to evaluate physical activity level in candidates. There is just a few studies used an objective device like triaxial accelerometer in the literature.
Physical inactivity as a cardiovascular risk factor is related with higher risks of cardiovascular diseases and complications after HSCT. Therefore, it is important to assess detailed physical activity along with its all aspects including energy expenditure, number of steps, activity types and durations in candidates of HSCT. However, impairments in energy expenditure, physical activity duration, metabolic equivalents of daily task (METs) and lying down duration are still unknown in candidates versus healthy individuals who are age and gender matched counterparts of candidates. Hence, it was aimed to compare physical activity parameters, pulmonary functions and quality of life scores of candidates with healthy individuals in the current study.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Candidates of HSCT | – | –Physical activity level using a metabolic holter device, dynamic lung volumes (FEV1, FVC, FEV1/FVC, PEF, FEF25-75%) using a spirometer and quality of life using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version 3.0 were objectively evaluated. |
| Healthy individuals | – | –Physical activity level using a metabolic holter device, dynamic lung volumes (FEV1, FVC, FEV1/FVC, PEF, FEF25-75%) using a spirometer and quality of life using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version 3.0 were objectively evaluated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were previously diagnosed with a hematological malignancy and determined to be a candidate for allogeneic-HSCT who were orientated from Bone Marrow Transplantation Unit for rehabilitation program. Healthy individuals were recruited from staff in the university and their healthy relatives.
Key inclusion criteria (7 listed)
- being aged between 18 and 65 years, being a candidate for either allogeneic or autologous HSCT before the start of conditioning regimen who were orientated from Bone Marrow Transplantation Unit,
- having a diagnosis with a hematologic malignancy,
- being clinically stabile,
- being functionally mobile
- receiving optimal standard medical therapy including antibiotics, supplements and other drugs.
Key exclusion criteria (5 listed)
- having cooperation problems, having orthopedic or neurological disease with a potential to limit daily walking,
- having comorbidities such as chronic obstructive pulmonary disease, cardiac diseases, acute infections and/or active hemorrhage (with hemoglobin values ≤8 g/L and platelet count ≤10.000 mm3)
- having any diagnosis of chronic diseases
- being current smokers
- being ex-smokers (≥10 pack*years)
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
Physical activity measurement
Time frame: during a total of 48 hours
Physical activity levels of all participants were assessed with a metabolic holter device.
2 secondary outcomes
Evaluation of dynamic lung volumes
Time frame: 5 minutes
General quality of life assesment: European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)
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 22 Oct 2020.
- Results publication: PubMed 16641398Copelan EA. Hematopoietic stem-cell transplantation. N Engl J Med. 2006 Apr 27;354(17):1813-26. doi: 10.1056/NEJMra052638. No abstract available.
- Results publication: PubMed 30763660Paudel N, Schulze D, Gentzler RD, Evens AM, Helenowski I, Dillehay G, Frankfurt O, Mehta J, Donnelly ED, Gordon LI, Winter JN, Mittal BB. Patterns of Failure and Survival Outcomes after Total Lymphoid Irradiation and High-Dose Chemotherapy with Autologous Stem Cell Transplantation for Relapsed or Refractory Classical Hodgkin Lymphoma. Int J Radiat Oncol Biol Phys. 2019 Jun 1;104(2):436-446. doi: 10.1016/j.ijrobp.2019.02.007. Epub 2019 Feb 11.
- Results publication: PubMed 30658224Mohammed J, Smith SR, Burns L, Basak G, Aljurf M, Savani BN, Schoemans H, Peric Z, Chaudhri NA, Chigbo N, Alfred A, Bakhsh H, Salooja N, Chris Chim A, Hashmi SK. Role of Physical Therapy before and after Hematopoietic Stem Cell Transplantation: White Paper Report. Biol Blood Marrow Transplant. 2019 Jun;25(6):e191-e198. doi: 10.1016/j.bbmt.2019.01.018. Epub 2019 Jan 15.
- Results publication: PubMed 21464398Wingard JR, Majhail NS, Brazauskas R, Wang Z, Sobocinski KA, Jacobsohn D, Sorror ML, Horowitz MM, Bolwell B, Rizzo JD, Socie G. Long-term survival and late deaths after allogeneic hematopoietic cell transplantation. J Clin Oncol. 2011 Jun 1;29(16):2230-9. doi: 10.1200/JCO.2010.33.7212. Epub 2011 Apr 4.
- Results publication: PubMed 24975331Majhail NS, Rizzo JD, Lee SJ, Aljurf M, Atsuta Y, Bonfim C, Burns LJ, Chaudhri N, Davies S, Okamoto S, Seber A, Socie G, Szer J, Van Lint MT, Wingard JR, Tichelli A; Center for International Blood and Marrow Transplant Research (CIBMTR); American Society for Blood and Marrow Transplantation (ASBMT); European Group for Blood and Marrow Transplantation (EBMT); Asia-Pacific Blood and Marrow Transplantation Group (APBMT); Bone Marrow Transplantation Society of Australia and New Zeland (BMTSANZ); East Mediterrnean Blood and Marrow Transplantation Group (EMBMT); Sociedale Brasileira de Transplante de Medula Ossea (SBTMO). [Recommended screening and preventive practices for long-term survivors after hematopoietic cell transplantation]. Rinsho Ketsueki. 2014 Jun;55(6):607-32. Japanese.
- Results publication: PubMed 23963412Vermaete N, Wolter P, Verhoef G, Gosselink R. Physical activity and physical fitness in lymphoma patients before, during, and after chemotherapy: a prospective longitudinal study. Ann Hematol. 2014 Mar;93(3):411-24. doi: 10.1007/s00277-013-1881-3. Epub 2013 Aug 21.
- Results publication: PubMed 23306934Hung YC, Bauer J, Horsley P, Waterhouse M, Bashford J, Isenring E. Changes in nutritional status, body composition, quality of life, and physical activity levels of cancer patients undergoing autologous peripheral blood stem cell transplantation. Support Care Cancer. 2013 Jun;21(6):1579-86. doi: 10.1007/s00520-012-1698-y. Epub 2013 Jan 10.
- Results publication: PubMed 16002928White AC, Terrin N, Miller KB, Ryan HF. Impaired respiratory and skeletal muscle strength in patients prior to hematopoietic stem-cell transplantation. Chest. 2005 Jul;128(1):145-52. doi: 10.1378/chest.128.1.145.
- 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 22526152Morishita S, Kaida K, Tanaka T, Itani Y, Ikegame K, Okada M, Ishii S, Kodama N, Ogawa H, Domen K. Prevalence of sarcopenia and relevance of body composition, physiological function, fatigue, and health-related quality of life in patients before allogeneic hematopoietic stem cell transplantation. Support Care Cancer. 2012 Dec;20(12):3161-8. doi: 10.1007/s00520-012-1460-5. Epub 2012 Apr 12.
- Individual participant dataSharing planned: No
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic Stem Cell Transplantation, run by Gazi University.
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 7 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Physical activity measurement (time frame: during a total of 48 hours). 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 NCT03915210, which also lists 10 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 22 Oct 2020.