Chronic Obstructive Pulmonary DiseaseUpstAIRNCT03564028
Energy Conservation Technique in COPD Patients
A study testing energy conservation technique in people with Chronic Obstructive Pulmonary Disease, run by Groupe Hospitalier du Havre at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- energy conservation technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jul 2018to 29 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of COPD
- Dyspnea in daily living (2-4 on the modified medical research council dyspnea scale)
- clinically stable
Who cannot join
- exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise.
- exacerbation during the study
- inability to climb 6 floors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Energy Conservation Technique During Stair Climbing in COPD Patients : a Randomized Controlled Trial
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- energy conservation technique, control session
- Keywords
- COPD, daily activity, stair climbing, rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
energy conservation techniqueOther
During the session of stair climbing, patients will perform a break at least of 5 seconds every 3 steps.
control sessionOther
Patients will realize one session of stair climbing at their own pace
| Study group | Role | What they receive |
|---|---|---|
| energy conservation technique | Experimental | Patients will perform one session of stair climbing of 108 steps (corresponding to 6 floors). Receives: Other: energy conservation technique |
| Control session | Other | Patients will perform one session of stair climbing of 108 steps (corresponding to 6 floors). Receives: Other: control session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Difference in time (seconds) will be evaluated using a stopwatch
Measured: 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
Difference in respiratory rate (cycles per minute) will be measured breath-by-breath using a Respiratory Inductive Plethysmography
Measured: 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
Difference in inspiratory capacity (Liters) will be measured using a portable spirometer
Measured: 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
Difference in Cardiac Frequence (bpm) using a pulse oximetry
Measured: 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
Difference in Oxygen Saturation
Measured: 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 peripheral muscle oxygenation
Muscle oxygenation (arbitrary unit) will be evaluated using Near-infrared spectroscopy technology.
Measured: 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 tidal volume
Difference in tidal volume (Liters) will be measured breath-by-breath using a portable spirometer
Measured: 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 muscular fatigue
Difference in muscular fatigue using Modified Borg Scale (0 - 10 points) 0=no muscular fatigue ; 10 = maximal effort
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start23 Jul 2018
- Primary completion29 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564028
- Sponsor's protocol ID
- 2018-A00566-49
- Acronym
- UpstAIR
- Status last verified
- Apr 2019
- First submitted
- 11 Jun 2018
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available after publication. Please contact Guillaume Prieur at gprieur.kine@gmail.com
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Energy Conservation Technique During Stair Climbing in COPD Patients : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03564028
- Acronym / sponsor ID
- UpstAIR / 2018-A00566-49
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, daily activity, stair climbing, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| energy conservation technique | Experimental | Other: energy conservation techniquePatients will perform one session of stair climbing of 108 steps (corresponding to 6 floors). |
| Control session | Other | Other: control sessionPatients will perform one session of stair climbing of 108 steps (corresponding to 6 floors). |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a diagnosis of COPD
- Dyspnea in daily living (2-4 on the modified medical research council dyspnea scale)
- clinically stable
Key exclusion criteria (3 listed)
- exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise.
- exacerbation during the study
- inability to climb 6 floors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| energy conservation techniqueDuring the session of stair climbing, patients will perform a break at least of 5 seconds every 3 steps. | Other | energy conservation technique |
| control sessionPatients will realize one session of stair climbing at their own pace | Other | Control session |
Primary outcome
Difference in Dyspnea at iso time and at time limit between the two sessions
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.
Difference in dyspnea using Modified Borg Scale (0 - 10 points) 0=no dyspnea ; 10 = maximal effort
8 secondary outcomes
difference in time required for the patient to climb the 6 floors
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.
Difference in respiratory rate
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.
Difference in inspiratory capacity
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.
Difference in Cardiac Frequency
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.
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.
Difference in peripheral muscle oxygenation
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.
Difference in tidal volume
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.
Difference in muscular fatigue
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Derived from this study: PubMed 32217783Prieur 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.
- Individual participant dataSharing planned: Yes. Data will be available after publication. Please contact Guillaume Prieur at gprieur.kine@gmail.com
Related trials for Chronic Obstructive Pulmonary Disease
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing energy conservation technique in people with Chronic Obstructive Pulmonary Disease, run by Groupe Hospitalier du Havre at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Dyspnea at iso time and at time limit between the two sessions (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03564028, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.