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CompletedNCT03564028UpstAIRUpdated Apr 3, 2019

Energy Conservation Technique in COPD Patients

An interventional study of energy conservation technique and control session in Chronic Obstructive Pulmonary Disease, sponsored by Groupe Hospitalier du Havre. Completed at 1 site in France. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-04-03.

Sponsored by Groupe Hospitalier du Havre · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
35 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
  • daily activity
  • stair climbing
  • rehabilitation
03

In context

Pulmonary Disease, Chronic Obstructive

4,253 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's enrollment of 22 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Groupe Hospitalier du Havre is the lead sponsor of 22 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise.
  • exacerbation during the study
  • inability to climb 6 floors
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    energy conservation technique

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

    Other: energy conservation technique

  • Other
    Control session

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

    Other: control session

Interventions

  • Otherenergy conservation technique

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

  • Othercontrol session

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

06

What researchers measure

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

    Time frame: 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

  1. difference in time required for the patient to climb the 6 floors

    Difference in time (seconds) will be evaluated using a stopwatch

    Time frame: 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.

  2. Difference in respiratory rate

    Difference in respiratory rate (cycles per minute) will be measured breath-by-breath using a Respiratory Inductive Plethysmography

    Time frame: 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. Difference in inspiratory capacity

    Difference in inspiratory capacity (Liters) will be measured using a portable spirometer

    Time frame: 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.

  4. Difference in Cardiac Frequency

    Difference in Cardiac Frequence (bpm) using a pulse oximetry

    Time frame: 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.

  5. Difference in Oxygen Saturation

    Difference in Oxygen Saturation

    Time frame: 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.

  6. Difference in peripheral muscle oxygenation

    Muscle oxygenation (arbitrary unit) will be evaluated using Near-infrared spectroscopy technology.

    Time frame: 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.

  7. Difference in tidal volume

    Difference in tidal volume (Liters) will be measured breath-by-breath using a portable spirometer

    Time frame: 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.

  8. Difference in muscular fatigue

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

    Time frame: 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.

07

Study locations

1 site
  • Groupe Hospitalier du Havre
    Le Havre, Normandy 76290, France
08

References and documents

Publications

  • 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. PubMed 32217783 ↗

Individual participant data

Plan to share: Yes — Data will be available after publication. Please contact Guillaume Prieur at gprieur.kine@gmail.com

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2018 to primary completion in Mar 2019, 8 months.

Of 796 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 8 months is below that.

Counting every sponsor, half of 848 studies reached it within 24 months; a quarter within 11 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 11, 2018
First posted
Jun 20, 2018
StartActual
Jul 23, 2018
Primary completionActual
Mar 29, 2019
CompletionActual
Mar 29, 2019
Last update
Apr 3, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03564028
Lead sponsor
Groupe Hospitalier du Havre
Responsible party
Sponsor
First posted
Jun 20, 2018
Start date
Jul 23, 2018
Primary completion
Mar 29, 2019
Completion
Mar 29, 2019
Last update
Apr 3, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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