Chronic Obstructive Pulmonary Disease and Allied ConditionsNCT02261337
Is Gait Speed and Sarcopenia Prognostic in Chronic Respiratory Disease?
An observational study of Chronic Obstructive Pulmonary Disease and Allied Conditions, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study aims to assess usual walking speed (4-metre gait speed) and markers of sarcopenia predict mortality in patients with chronic respiratory disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease and Allied Conditions
- How many people
- 565 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2013to Apr 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient with chronic respiratory disease. The cohort will be recruited from Harefield hospital.
Who may be able to join
- All patients with chronic respiratory disease who are able to complete the assessments.
Who cannot join
- Significant co-morbidities that would limit walking ability, exercise capacity or make exercise unsafe (e.g. unstable ischaemic heart disease, neuromuscular disease, severe hip/lower limb joint pain, peripheral vascular disease, lower limb amputation).
- Any patient whom the Chief Investigator feels it is unsafe to exercise (e.g. unstable cardiovascular disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Gait Speed and Markers of Sarcopenia Predict Prognosis in Patients With Chronic Respiratory Disease?
This study aims to assess usual walking speed (4-metre gait speed) and markers of sarcopenia predict mortality in patients with chronic respiratory disease.
- Keywords
- Sarcopenia
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participant deaths
Measured: 1 year
Secondary outcomes (5)
Number of participant deaths
Measured: 2 years and 5 years
Number of exacerbations as defined by a worsening of symptoms that warrant a change in medication.
Measured: 1 and 2 years
Number of hospital admissions
Measured: 1 and 2 years
Number of patients admitted to a nursing home
Measured: 2 and 5 years
Number of hospital bed days
Measured: 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2018
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease and Allied ConditionsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 565 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Sponsor
- Investigators
- William DC Man, FRCP PhD, Principal investigator, NIHR Respiratory Biomedical Research Unit Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261337
- Sponsor's protocol ID
- 2013LF003H
- Status last verified
- Oct 2022
- First submitted
- 1 May 2014
- Last updated
- 1 Nov 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Gait Speed and Markers of Sarcopenia Predict Prognosis in Patients With Chronic Respiratory Disease?
- ClinicalTrials.gov ID
- NCT02261337
- Acronym / sponsor ID
- 2013LF003H
- Keywords
- Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 565 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- Dec 2013 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 10 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.
This study aims to assess usual walking speed (4-metre gait speed) and markers of sarcopenia predict mortality in patients with chronic respiratory disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with chronic respiratory disease. The cohort will be recruited from Harefield hospital.
Key inclusion criteria (1 listed)
- All patients with chronic respiratory disease who are able to complete the assessments.
Key exclusion criteria (2 listed)
- Significant co-morbidities that would limit walking ability, exercise capacity or make exercise unsafe (e.g. unstable ischaemic heart disease, neuromuscular disease, severe hip/lower limb joint pain, peripheral vascular disease, lower limb amputation).
- Any patient whom the Chief Investigator feels it is unsafe to exercise (e.g. unstable cardiovascular disease).
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
Number of participant deaths
Time frame: 1 year
5 secondary outcomes
Number of participant deaths
Time frame: 2 years and 5 years
Number of exacerbations as defined by a worsening of symptoms that warrant a change in medication.
Time frame: 1 and 2 years
Number of hospital admissions
Time frame: 1 and 2 years
Number of patients admitted to a nursing home
Time frame: 2 and 5 years
Number of hospital bed days
Time frame: 1 and 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
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.
William DC Man, FRCP PhD principal investigator
NIHR Respiratory Biomedical Research Unit Royal Brompton & Harefield NHS Foundation Trust
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 Chronic Obstructive Pulmonary Disease and Allied Conditions, run by Royal Brompton & Harefield NHS Foundation Trust 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 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. 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 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?
Number of participant deaths (time frame: 1 year). 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 1 Nov 2022.