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Energy Conservation Technique in COPD Patients (UpstAIR)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
energy conservation technique
control session
Sponsored by
Groupe Hospitalier du Havre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, daily activity, stair climbing, rehabilitation

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Groupe Hospitalier du Havre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

energy conservation technique

Control session

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

difference in time required for the patient to climb the 6 floors
Difference in time (seconds) will be evaluated using a stopwatch
Difference in respiratory rate
Difference in respiratory rate (cycles per minute) will be measured breath-by-breath using a Respiratory Inductive Plethysmography
Difference in inspiratory capacity
Difference in inspiratory capacity (Liters) will be measured using a portable spirometer
Difference in Cardiac Frequency
Difference in Cardiac Frequence (bpm) using a pulse oximetry
Difference in Oxygen Saturation
Difference in Oxygen Saturation
Difference in peripheral muscle oxygenation
Muscle oxygenation (arbitrary unit) will be evaluated using Near-infrared spectroscopy technology.
Difference in tidal volume
Difference in tidal volume (Liters) will be measured breath-by-breath using a portable spirometer
Difference in muscular fatigue
Difference in muscular fatigue using Modified Borg Scale (0 - 10 points) 0=no muscular fatigue ; 10 = maximal effort

Full Information

First Posted
June 11, 2018
Last Updated
April 1, 2019
Sponsor
Groupe Hospitalier du Havre
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1. Study Identification

Unique Protocol Identification Number
NCT03564028
Brief Title
Energy Conservation Technique in COPD Patients
Acronym
UpstAIR
Official Title
Effects of Energy Conservation Technique During Stair Climbing in COPD Patients : a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 23, 2018 (Actual)
Primary Completion Date
March 29, 2019 (Actual)
Study Completion Date
March 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier du Havre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, daily activity, stair climbing, rehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
energy conservation technique
Arm Type
Experimental
Arm Description
Patients will perform one session of stair climbing of 108 steps (corresponding to 6 floors).
Arm Title
Control session
Arm Type
Other
Arm Description
Patients will perform one session of stair climbing of 108 steps (corresponding to 6 floors).
Intervention Type
Other
Intervention Name(s)
energy conservation technique
Intervention Description
During the session of stair climbing, patients will perform a break at least of 5 seconds every 3 steps.
Intervention Type
Other
Intervention Name(s)
control session
Intervention Description
Patients will realize one session of stair climbing at their own pace
Primary Outcome Measure Information:
Title
Difference in Dyspnea at iso time and at time limit between the two sessions
Description
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 Outcome Measure Information:
Title
difference in time required for the patient to climb the 6 floors
Description
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.
Title
Difference in respiratory rate
Description
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.
Title
Difference in inspiratory capacity
Description
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.
Title
Difference in Cardiac Frequency
Description
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.
Title
Difference in Oxygen Saturation
Description
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.
Title
Difference in peripheral muscle oxygenation
Description
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.
Title
Difference in tidal volume
Description
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.
Title
Difference in muscular fatigue
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a diagnosis of COPD Dyspnea in daily living (2-4 on the modified medical research council dyspnea scale) clinically stable Exclusion Criteria: exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise. exacerbation during the study inability to climb 6 floors
Facility Information:
Facility Name
Groupe Hospitalier du Havre
City
Le Havre
State/Province
Normandie
ZIP/Postal Code
76290
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available after publication. Please contact Guillaume Prieur at gprieur.kine@gmail.com
Citations:
PubMed Identifier
32217783
Citation
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.
Results Reference
derived

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Energy Conservation Technique in COPD Patients

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