Allogeneic Hematopoietic Stem Cell TransplantationNCT02270346
Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
A study testing Inspiratory muscle training in people with Allogeneic Hematopoietic Stem Cell Transplantation, run by Gazi University.
Trial summary
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) causes various toxic effects in many body tissues, organs and systems such as immune, cardiovascular, pulmonary, gastrointestinal, neuroendocrine and musculoskeletal systems, liver, kidneys and skin.Available limited numbers of studies showed that… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation
- What is being tested?
- Inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Sep 2013
- 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
- Allo-HSC recipients (˃100 days past post-transplant status),
- 18-65 years of age,
- Under standard medications
Who cannot join
- Having cognitive disorder, orthopedic problem or neurological disease that were affecting functional capacity,
- Additional heart and lung diseases such as asthma, chronic obstructive pulmonary disease, acute infections or pneumonia,
- Problems prevented performing assessment and training such as visual problems and mucositis
About this study
Official title: Effects of Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) causes various toxic effects in many body tissues, organs and systems such as immune, cardiovascular, pulmonary, gastrointestinal, neuroendocrine and musculoskeletal systems, liver, kidneys and skin.Available limited numbers of studies showed that inspiratory muscle weakness in allo-HSCT candidates and recipients. Although meta-analysis, systematic reviews and studies demonstrated beneficial effects of inspiratory muscle training on several outcomes in different disease groups; chronic obstructive pulmonary disease, bronchiectasis and heart failure, no published paper reported the effects of IMT in allo-HSC recipients.
Read the detailed description
Thirty-eight allo-HSCT recipients (˃100 days past post-transplant status) were included. Before and after 6-week IMT, maximal and submaximal exercise capacity, respiratory and peripheral muscle strength, pulmonary functions, dyspnea and fatigue perception, depression and quality of life were evaluated. Primary outcome measurement was respiratory muscle strength, secondary outcomes were exercise capacity, dyspnea, peripheral muscle strength, quality of life, fatigue and depression.
- Being tested
- Inspiratory muscle training, Sham inspiratory muscle training
- Keywords
- Allogeneic HSCT, Inspiratory Muscle Training, Exercise Capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingDevice
Treatment group received inspiratory muscle training using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 40% of maximal inspiratory pressure (MIP).
The MIP was measured at supervised session each week, and 40% of measured MIP value was the new training workload.
The treatment group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department.
Sham inspiratory muscle trainingDevice
Control group received sham inspiratory muscle training using threshold loading device (POWERbreathe Classic IMT Technologies Ltd. Birmingham, England) at fixed workload, 5% of MIP.
The control group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | Intervention: Treatment group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device. Receives: Device: Inspiratory muscle training |
| Control group | Sham comparator | Sham: Control group received sham inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device . Receives: Device: Sham inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory and expiratory muscle strength (MIP, MEP)
Mouth pressure device
Measured: 6 weeks
Secondary outcomes (8)
Fatigue
Fatigue Impact Scale (FIS)
Measured: 6 weeks
Pulmonary function
Spirometry
Measured: 6 weeks
Peripheral muscle strength
Hand held dynamometer
Measured: 6 weeks
Dyspnea
Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales,
Measured: 6 weeks
Depression
Montgomery Asberg Depression Rating Scale (MADRS)
Measured: 6 weeks
Quality of life
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C-30 version 3.0 (Turkish versions of all scales)
Measured: 6 weeks
Submaximal exercise capacity
Six-minute walk test (6MWT)
Measured: 6 weeks
Maximal exercise capacity
Modified incremental shuttle walk test (ISWT)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startMar 2012
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Allogeneic 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 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 UniversityZeynep Arıbaş, MSc., Principal investigator, Gazi UniversityZeynep Şahika Akı, MD, PhD., Principal investigator, Gazi UniversityGülsan Türköz Sucak, MD, PhD., Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270346
- Sponsor's protocol ID
- GaziUniversity
- Status last verified
- Oct 2014
- First submitted
- 14 Oct 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dimeo FC, Tilmann MH, Bertz H, Kanz L, Mertelsmann R, Keul J. Aerobic exercise in the rehabilitation of cancer patients after high dose chemotherapy and autologous peripheral stem cell transplantation. Cancer. 1997 May 1;79(9):1717-22.
PubMed 9128987Ferrell B, Grant M, Schmidt GM, Rhiner M, Whitehead C, Fonbuena P, Forman SJ. The meaning of quality of life for bone marrow transplant survivors. Part 1. The impact of bone marrow transplant on quality of life. Cancer Nurs. 1992 Jun;15(3):153-60.
PubMed 1611601White 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 16002928Kovalszki 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 18264142Bargi 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 26135532
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
- ClinicalTrials.gov ID
- NCT02270346
- Acronym / sponsor ID
- GaziUniversity
- Keywords
- Allogeneic HSCT, Inspiratory Muscle Training, Exercise Capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 21 Oct 2014 (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.
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) causes various toxic effects in many body tissues, organs and systems such as immune, cardiovascular, pulmonary, gastrointestinal, neuroendocrine and musculoskeletal systems, liver, kidneys and skin.Available limited numbers of studies showed that inspiratory muscle weakness in allo-HSCT candidates and recipients. Although meta-analysis, systematic reviews and studies demonstrated beneficial effects of inspiratory muscle training on several outcomes in different disease groups; chronic obstructive pulmonary disease, bronchiectasis and heart failure, no published paper reported the effects of IMT in allo-HSC recipients.
Detailed description
Thirty-eight allo-HSCT recipients (˃100 days past post-transplant status) were included. Before and after 6-week IMT, maximal and submaximal exercise capacity, respiratory and peripheral muscle strength, pulmonary functions, dyspnea and fatigue perception, depression and quality of life were evaluated. Primary outcome measurement was respiratory muscle strength, secondary outcomes were exercise capacity, dyspnea, peripheral muscle strength, quality of life, fatigue and depression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Device: Inspiratory muscle trainingIntervention: Treatment group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device. |
| Control group | Sham comparator | Device: Sham inspiratory muscle trainingSham: Control group received sham inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Allo-HSC recipients (˃100 days past post-transplant status),
- 18-65 years of age,
- Under standard medications
Key exclusion criteria (3 listed)
- Having cognitive disorder, orthopedic problem or neurological disease that were affecting functional capacity,
- Additional heart and lung diseases such as asthma, chronic obstructive pulmonary disease, acute infections or pneumonia,
- Problems prevented performing assessment and training such as visual problems and mucositis
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 |
|---|---|---|
| Inspiratory muscle trainingTreatment group received inspiratory muscle training using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 40% of maximal inspiratory pressure (MIP). The MIP was measured at supervised session each week, and 40% of measured MIP value was the new training workload. The treatment group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department. | Device | Treatment group |
| Sham inspiratory muscle trainingControl group received sham inspiratory muscle training using threshold loading device (POWERbreathe Classic IMT Technologies Ltd. Birmingham, England) at fixed workload, 5% of MIP. The control group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department. | Device | Control group |
Primary outcome
Inspiratory and expiratory muscle strength (MIP, MEP)
Time frame: 6 weeks
Mouth pressure device
8 secondary outcomes
Fatigue
Time frame: 6 weeks
Pulmonary function
Time frame: 6 weeks
Peripheral muscle strength
Time frame: 6 weeks
Dyspnea
Time frame: 6 weeks
Depression
Time frame: 6 weeks
Quality of life
Time frame: 6 weeks
Submaximal exercise capacity
Time frame: 6 weeks
Maximal exercise capacity
Time frame: 6 weeks
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 21 Oct 2014.
- Results publication: PubMed 9128987Dimeo FC, Tilmann MH, Bertz H, Kanz L, Mertelsmann R, Keul J. Aerobic exercise in the rehabilitation of cancer patients after high dose chemotherapy and autologous peripheral stem cell transplantation. Cancer. 1997 May 1;79(9):1717-22.
- Results publication: PubMed 1611601Ferrell B, Grant M, Schmidt GM, Rhiner M, Whitehead C, Fonbuena P, Forman SJ. The meaning of quality of life for bone marrow transplant survivors. Part 1. The impact of bone marrow transplant on quality of life. Cancer Nurs. 1992 Jun;15(3):153-60.
- 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 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.
- Derived from this study: 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.
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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
Zeynep Arıbaş, MSc. principal investigator
Gazi University
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training in people with Allogeneic 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 3 inclusion and 3 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 21 Oct 2014. 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. Some participants in this study may receive a placebo. 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?
Inspiratory and expiratory muscle strength (MIP, MEP) (time frame: 6 weeks). 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 NCT02270346, which also lists 5 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 21 Oct 2014.