NCT04006015

Brief Summary

This research project incorporates a series of studies to investigate the relationship between physical performance (e.g. tests of strength, balance and walking distance) and physical activity (activity measured in day to day life) in people with COPD and other chronic lung diseases.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 24, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

June 24, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

5.3 years

First QC Date

June 24, 2019

Last Update Submit

December 7, 2023

Conditions

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

  • Free-living gait stability as assessed by activity monitor

    The free-living gait stability parameters derived from the fixed body sensor worn during activity monitoring at home.

    7 days.

Secondary Outcomes (10)

  • Physical activity assessed by step count using activity monitor

    7 days.

  • Clinical balance assessment

    Assessed during single clinical assessement at baseline.

  • Physical performance assessment

    Assessed during single clinical assessment at baseline.

  • Balance confidence

    Assessed during a single clinical assessment at baseline.

  • Walking distance in metres

    Assessed during a single clinical assessment at baseline.

  • +5 more secondary outcomes

Study Arms (3)

Main study group

31 people with COPD and 31 controls in the main study group.

Other: No intervention being delivered.

six-minute walk substudy

We will aim to have 40 participants participating in the 6 minute walk sub-study.

Other: No intervention being delivered.

Qualitative dance substudy

We will aim for 20 participants.

Other: No intervention being delivered.

Interventions

No interventions are being delivered.

Main study groupQualitative dance substudysix-minute walk substudy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with stable chronic lung disease.

You may qualify if:

  • Adults with stable chronic lung disease
  • Able to understand instructions.
  • Age and sex matched healthy controls.

You may not qualify if:

  • For the main study, the presence of other comorbidities causing a significant reduction in mobility (for example stroke with neurological deficits, severe arthritis, significant peripheral neuropathy, significant visual impairment, dementia etc.).
  • exacerbation of lung disease within the last 2 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart and Lung Institute, Imperial College London

London, United Kingdom

RECRUITING

Related Publications (1)

  • Philip KEJ, Lewis A, Williams S, Buttery SC, Polkey MI, Man W, Fancourt D, Hopkinson NS. Dance for people with chronic respiratory disease: a qualitative study. BMJ Open. 2020 Oct 13;10(10):e038719. doi: 10.1136/bmjopen-2020-038719.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nicholas Hopkinson, PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Keir EJ Philip, MRCP

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2019

First Posted

July 2, 2019

Study Start

June 24, 2019

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

December 8, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations