NCT03564028

Brief Summary

Chronic obstructive pulmonary disease (COPD) is characterised by non-reversible bronchial obstruction associated with systemic disorders and comorbid factors. Dynamic hyperinflation during an exercise increase dyspnea and can reduce exercise capacity. Stair climbing is associated with prolonged dynamic hyperinflation and severe dyspnea in COPD patients. The aim of this study is to carry out the effect of an energy conservation technique on dyspnea to facilitate stair climbing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

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

First Submitted

Initial submission to the registry

June 11, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 23, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2019

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

June 11, 2018

Last Update Submit

April 1, 2019

Conditions

Keywords

COPDdaily activitystair climbingrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Difference in Dyspnea at iso time and at time limit between the two sessions

    Difference in dyspnea using Modified Borg Scale (0 - 10 points) 0=no dyspnea ; 10 = maximal effort

    The outcome will be measured before, at the end and every one minute during the stair climbing sessions. The two stair climbing sessions will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.

Secondary Outcomes (8)

  • difference in time required for the patient to climb the 6 floors

    The outcome will be collected at the end of each sessions. The two stair climbing sessions will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.

  • Difference in respiratory rate

    Data will be continuously collected during every sessions. The two stair climbing sessions will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.

  • Difference in inspiratory capacity

    The outcome will be collected before and at the end of each sessions (within 2 minutes after the end). The two stair climbing sessions will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.

  • Difference in Cardiac Frequency

    Data will be continuously collected during every sessions. The two stair climbing sessions will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.

  • Difference in Oxygen Saturation

    Data will be continuously collected during every sessions. The two stair climbing sessions will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day.

  • +3 more secondary outcomes

Study Arms (2)

energy conservation technique

EXPERIMENTAL

Patients will perform one session of stair climbing of 108 steps (corresponding to 6 floors).

Other: energy conservation technique

Control session

OTHER

Patients will perform one session of stair climbing of 108 steps (corresponding to 6 floors).

Other: control session

Interventions

During the session of stair climbing, patients will perform a break at least of 5 seconds every 3 steps.

energy conservation technique

Patients will realize one session of stair climbing at their own pace

Control session

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a diagnosis of COPD
  • Dyspnea in daily living (2-4 on the modified medical research council dyspnea scale)
  • clinically stable

You may not qualify if:

  • exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise.
  • exacerbation during the study
  • inability to climb 6 floors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier du Havre

Le Havre, Normandy, 76290, France

Location

Related Publications (1)

  • Prieur G, Combret Y, Medrinal C, Arnol N, Bonnevie T, Gravier FE, Quieffin J, Lamia B, Reychler G, Borel JC. Energy conservation technique improves dyspnoea when patients with severe COPD climb stairs: a randomised crossover study. Thorax. 2020 Jun;75(6):510-512. doi: 10.1136/thoraxjnl-2019-214295. Epub 2020 Mar 26.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Patients will perform two stair climbing sessions (each session include 108 steps) under two different conditions on the same day with at least 30 minutes of rest between the two sessions. the order of the two conditions will be randomly assigned
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2018

First Posted

June 20, 2018

Study Start

July 23, 2018

Primary Completion

March 29, 2019

Study Completion

March 29, 2019

Last Updated

April 3, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

Data will be available after publication. Please contact Guillaume Prieur at gprieur.kine@gmail.com

Locations