NCT02261337

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
565

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

4.3 years

First QC Date

May 1, 2014

Last Update Submit

October 30, 2022

Conditions

Chronic Obstructive Pulmonary Disease and Allied Conditions

Keywords

Sarcopenia

Outcome Measures

Primary Outcomes (1)

  • Number of participant deaths

    1 year

Secondary Outcomes (5)

  • Number of participant deaths

    2 years and 5 years

  • Number of exacerbations as defined by a worsening of symptoms that warrant a change in medication.

    1 and 2 years

  • Number of hospital admissions

    1 and 2 years

  • Number of patients admitted to a nursing home

    2 and 5 years

  • Number of hospital bed days

    1 and 2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient with chronic respiratory disease. The cohort will be recruited from Harefield hospital.

You may qualify if:

  • All patients with chronic respiratory disease who are able to complete the assessments.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harefield hospital

Harefield, Middlesex, UB96JH, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveSarcopenia

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Study Officials

  • William DC Man, FRCP PhD

    NIHR Respiratory Biomedical Research Unit Royal Brompton & Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2014

First Posted

October 10, 2014

Study Start

December 1, 2013

Primary Completion

April 1, 2018

Study Completion

April 1, 2022

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

GB(1)