NCT03286660

Brief Summary

Improvement in the functional functioning and dyspnea of COPD patients after a rehabilitation program (RHB) is assessed by exercise tests and questionnaires difficult to replicate outside specialized centers. In order to monitor the eventual decline of patients in the course of their RHB management, Chair Rise Tests (3CRT-1CRT-5STS) and short questionnaires were developed (CAT-DIRECT). The goal of this prospective, multicenter, real-life study is to compare the change in several functional function tests and questionnaires of quality of life and dyspnea related to daily activities. In addition, MCIDs of the 3CRT and the DIRECT questionnaire (Disability Related to COPS Tool) were specified.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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 8, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

2.6 years

First QC Date

September 9, 2017

Last Update Submit

September 13, 2017

Conditions

EvaluationsRehabilitationCOPD

Keywords

Exercise testsCOPDRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change of number of rise during 3 minutes Chair Rise Test (3CRT)

    The change of total number of rise during a 3 minutes Chair Rise Test (3CRT) from baseline

    At Baseline, at 2 and 8 weeks.

Secondary Outcomes (6)

  • Change of number of rise during 1 minute Chair Rise Test (1CRT)

    At Baseline, at 2 and 8 weeks.

  • Change of Time to perform 5 sit to stand

    At Baseline, at 2 and 8 weeks.

  • The change of Total score for the DIsability RElated to COPD Tool (DIRECT)

    At Baseline and at 8 weeks.

  • Difference in physiological response (SpO2 and HR) during the 3 Chair Rise Tests (3CRT-1CRT-5STS)

    At Baseline, at 2 and 8 weeks.

  • Change in endurance time at constant power on cyclo ergometer,

    At Baseline, at 2 and 8 weeks.

  • +1 more secondary outcomes

Study Arms (1)

COPD patients

OTHER

All convenient COPD patients admitted in real life for a rehabilitation program were included. Exercises consist on a Chair Rise Tests and short questionnaire were added to the usual tools for the evaluation.

Diagnostic Test: Chair Rise Tests and short questionnaire

Interventions

Chair Rise Tests and short questionnaireDIAGNOSTIC_TEST

Exercises consist on a Chair Rise Tests and short questionnaire It is a functional test evaluating the number of chair rise over a given time and / or frequency. This test is combined with a questionnaire to collect quantitative and qualitative information: * dyspnea and muscular fatigue at rest before the start of the test and at the end of the exercise * Saturation at rest, and at the end of the exercise * the number of total a chair rise

COPD patients

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with COPD Gold II to IV
  • Patient admitted for a rehabilitation program in real life
  • Person affiliated to the Social Security or beneficiary of such a scheme
  • Informed and written consent by patient or legal representative

You may not qualify if:

  • Patient limited by reduced locomotor activity or joint pain that compromises their participation in a rehabilitation program
  • Patients with a performance less than 250 meters during 6MWT
  • Non-stable cardiac disease
  • Any other lung disease than COPD
  • Person subject to a legal protection measure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Universitaire

Grenoble, France

Location

Hôpital Calmette, CHRU

Lille, France

Location

Related Publications (1)

  • Levesque J, Antoniadis A, Li PZ, Herengt F, Brosson C, Grosbois JM, Bernady A, Bender A, Favre M, Guerder A, Surpas P, Similowski T, Aguilaniu B. Minimal clinically important difference of 3-minute chair rise test and the DIRECT questionnaire after pulmonary rehabilitation in COPD patients. Int J Chron Obstruct Pulmon Dis. 2019 Jan 22;14:261-269. doi: 10.2147/COPD.S187567. eCollection 2019.

    PMID: 30774324DERIVED

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

  • Bernard AGUILANIU, MD,PhD

    University Grenoble Alps

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2017

First Posted

September 18, 2017

Study Start

December 8, 2014

Primary Completion

July 24, 2017

Study Completion

July 24, 2017

Last Updated

September 18, 2017

Record last verified: 2017-09

Locations

FR(2)