Chronic Obstructive Pulmonary DiseaseNCT02532075
The Effect of a Respiratory Muscle Warm-up Prior to Exercise in Patients With Chronic Obstructive Pulmonary Disease
A study testing Inspiratory Warm Up, Expiratory Warm Up and Combination Warm Up in people with Chronic Obstructive Pulmonary Disease, run by University of Portsmouth at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the effects of performing a breathing muscle warm up before exercise in patients who have chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Inspiratory Warm Up, Expiratory Warm Up and Combination Warm Up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Oct 2016
- 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 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of COPD
- Aged between 35 and 90 years
- Able to fluently read and speak English
- Willing and able to sign informed consent
- Be able to comply with the procedures outlined for the study
Who cannot join
- Cardiac disease (including arrhythmias)
- A medicinal requirement for rate limiting calcium antagonists or beta blockers
- Cerebrovascular disease
- Peripheral vascular disease
- Requirement for supplemental oxygen therapy
- CO2 (carbon dioxide) retention
Show all 13Show fewer
- Malignancy
- Orthopaedic or neurological conditions effecting the ability to exercise
- Clinically apparent heart failure
- Renal, hepatic or inflammatory disease
- Instability of COPD
- Any other reason leading to the inability to complete the requirements of the study.
- Additionally: If participants have a resting HR above 120beats.min-1, systolic blood pressure above 180mm Hg or diastolic blood pressure above 100mm Hg prior to the 6 minute walk test they will not be able to commence the test.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Portsmouth - Department of Sport and Exercise Science
Portsmouth, Hampshire, PO1 2ER
About this study
Official title: The Effect of a Respiratory Muscle Warm-up Prior to Exercise in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to investigate the effects of performing a breathing muscle warm up before exercise in patients who have chronic obstructive pulmonary disease (COPD). The main aim is to see whether performing a breathing muscle warm up can improve distance walked in a 6 minute walk test and also decrease perceptions of effort and breathlessness.
Read the detailed description
The study will follow a counter-balanced repeated measures design involving six visits to the exercise laboratory. Following pre-screening and familiarisation (visits 1 and 2), participants will perform inspiratory warm up, expiratory warm up, combination warm up and control trials (visits 3 - 6) in a counter-balanced order separated by at least 48 hours between trials.
The four separate sessions will contain: lung function measurements assessed by performing breathing manoeuvres through a mouthpiece (spirometery or body plethysmography) before performing a breathing muscle warm up by breathing against a resistance through a small handheld device (PowerLung). Participants will then be asked perform a second set of lung function measurements and will then be asked to perform a 6 minute walk test wearing a face mask and a portable device (gas analysis), a small device clipped to a finger (pulse oximeter) and wearing a heart rate monitor. During this 6 minute walk test participants will also be asked to rate their perceived effort and level of breathlessness at 60m intervals. Following the test there will be a period of seated rest wearing the face mask and portable device for up to 20 minutes with one more set of lung function measurements.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Inspiratory Warm Up, Expiratory Warm Up, Combination Warm Up, Control Trial
- Keywords
- COPD, Respiratory Muscle Warm Up
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Warm UpOther
Inspiratory muscle warm up. Inhaling against a resistance for two sets of 15 breaths using a PowerLung.
Expiratory Warm UpOther
Expiratory muscle warm up. Exhaling against a resistance for two sets of 15 breaths using a PowerLung.
Combination Warm UpOther
Combination of inspiratory and expiratory muscle warm up. One set of 15 breaths inhaling followed by one set 15 breaths exhaling.
Control TrialOther
Control Trial. No respiratory muscle warm up to act as a comparison to the other three intervention trials.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Warm Up | Experimental | (IWU). Two sets of 15 breaths Receives: Other: Inspiratory Warm Up |
| Expiratory Warm Up | Experimental | (EWU). Two sets of 15 breaths Receives: Other: Expiratory Warm Up |
| Combination Warm Up | Experimental | (RWU). One set of 15 breaths inspiratory and one set of 15 breaths expiratory Receives: Other: Combination Warm Up |
| Control Trial | Other | No warm up Receives: Other: Control Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance walked in the 6 minute walk test
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Rating of perceived exertion (RPE) in the 6 minute walk test
Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Rating of dyspnoea during the six minute walk test
Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Secondary outcomes (20)
Heart rate (HR)
Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Expired gas
Measured from a few minutes prior to the six minute walk test until 20 minutes post test (or until VO2 returns to baseline following test). A brief gap in measurement will occur 5 minutes test to allow for a measure of pulmonary function.
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Peripheral arterial oxygen saturation (SpO2)
Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: maximal inspiratory mouth pressure (MIP)
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: maximal expiratory mouth pressure (MEP)
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: specific airway resistance (sRaw)
Note: only if body plethysmography is available. Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: airway resistance (Raw)
Note: only if body plethysmography is available. Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: functional residual capacity (FRCpleth)
Note: only if body plethysmography is available. Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: peak inspiratory flow (PIF)
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: peak expiratory flow (PEF)
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: forced expiratory flow at 25, 50 and 75% maximal vital capacity) (FEF 25, 50, 75)
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: forced expiratory volume in one second (FEV1)
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: forced vital capacity (FVC)
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: residual volume (RV)
Note: only if body plethysmography is available. Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: tidal volume (VT)
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: total lung capacity (TLC)
Note: only if body plethysmography is available. Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: inspiratory residual volume (IRV)
Note: only if body plethysmography is available. Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: expiratory residual volume (ERV)
Note: only if body plethysmography is available. Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: inspiratory capacity (IC)
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: inspiratory vital capacity (IVC)
Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).
Measured: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startFeb 2016
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Portsmouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Williamson, University of Portsmouth
- Investigators
- Craig Williamson, MSc, Principal investigator, PhD Research Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532075
- Sponsor's protocol ID
- RWU-01
- Status last verified
- Oct 2016
- First submitted
- 13 Aug 2015
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Respiratory Muscle Warm-up Prior to Exercise in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02532075
- Acronym / sponsor ID
- RWU-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Respiratory Muscle Warm Up
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of PortsmouthUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 25 Aug 2015 (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.
The purpose of this study is to investigate the effects of performing a breathing muscle warm up before exercise in patients who have chronic obstructive pulmonary disease (COPD). The main aim is to see whether performing a breathing muscle warm up can improve distance walked in a 6 minute walk test and also decrease perceptions of effort and breathlessness.
Detailed description
The study will follow a counter-balanced repeated measures design involving six visits to the exercise laboratory. Following pre-screening and familiarisation (visits 1 and 2), participants will perform inspiratory warm up, expiratory warm up, combination warm up and control trials (visits 3 - 6) in a counter-balanced order separated by at least 48 hours between trials.
The four separate sessions will contain: lung function measurements assessed by performing breathing manoeuvres through a mouthpiece (spirometery or body plethysmography) before performing a breathing muscle warm up by breathing against a resistance through a small handheld device (PowerLung). Participants will then be asked perform a second set of lung function measurements and will then be asked to perform a 6 minute walk test wearing a face mask and a portable device (gas analysis), a small device clipped to a finger (pulse oximeter) and wearing a heart rate monitor. During this 6 minute walk test participants will also be asked to rate their perceived effort and level of breathlessness at 60m intervals. Following the test there will be a period of seated rest wearing the face mask and portable device for up to 20 minutes with one more set of lung function measurements.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Warm Up | Experimental | Other: Inspiratory Warm Up(IWU). Two sets of 15 breaths |
| Expiratory Warm Up | Experimental | Other: Expiratory Warm Up(EWU). Two sets of 15 breaths |
| Combination Warm Up | Experimental | Other: Combination Warm Up(RWU). One set of 15 breaths inspiratory and one set of 15 breaths expiratory |
| Control Trial | Other | Other: Control TrialNo warm up |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A clinical diagnosis of COPD
- Aged between 35 and 90 years
- Able to fluently read and speak English
- Willing and able to sign informed consent
- Be able to comply with the procedures outlined for the study
Key exclusion criteria (13 listed)
- Cardiac disease (including arrhythmias)
- A medicinal requirement for rate limiting calcium antagonists or beta blockers
- Cerebrovascular disease
- Peripheral vascular disease
- Requirement for supplemental oxygen therapy
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 Warm UpInspiratory muscle warm up. Inhaling against a resistance for two sets of 15 breaths using a PowerLung. | Other | Inspiratory Warm Up |
| Expiratory Warm UpExpiratory muscle warm up. Exhaling against a resistance for two sets of 15 breaths using a PowerLung. | Other | Expiratory Warm Up |
| Combination Warm UpCombination of inspiratory and expiratory muscle warm up. One set of 15 breaths inhaling followed by one set 15 breaths exhaling. | Other | Combination Warm Up |
| Control TrialControl Trial. No respiratory muscle warm up to act as a comparison to the other three intervention trials. | Other | Control Trial |
Primary outcome
Distance walked in the 6 minute walk test
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Rating of perceived exertion (RPE) in the 6 minute walk test
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.
Rating of dyspnoea during the six minute walk test
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.
20 secondary outcomes
Heart rate (HR)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Expired gas
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Peripheral arterial oxygen saturation (SpO2)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: maximal inspiratory mouth pressure (MIP)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: maximal expiratory mouth pressure (MEP)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: specific airway resistance (sRaw)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: airway resistance (Raw)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: functional residual capacity (FRCpleth)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: peak inspiratory flow (PIF)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: peak expiratory flow (PEF)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: forced expiratory flow at 25, 50 and 75% maximal vital capacity) (FEF 25, 50, 75)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: forced expiratory volume in one second (FEV1)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: forced vital capacity (FVC)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: residual volume (RV)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: tidal volume (VT)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: total lung capacity (TLC)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: inspiratory residual volume (IRV)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: expiratory residual volume (ERV)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: inspiratory capacity (IC)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Pulmonary function: inspiratory vital capacity (IVC)
Time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Craig Williamson, MSc principal investigator
PhD Research Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Warm Up, Expiratory Warm Up and Combination Warm Up in people with Chronic Obstructive Pulmonary Disease, run by University of Portsmouth at 1 site in United Kingdom.
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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 27 Oct 2016. 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 United Kingdom. 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 was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
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?
Distance walked in the 6 minute walk test (time frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.