Energy Conservation Technique in COPD Patients (UpstAIR)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: energy conservation technique; Other: control session

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Normandie
    • Le Havre, Normandie, France, 76290
      • Groupe Hospitalier Du Havre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: energy conservation technique; Patients will perform one session of stair climbing of 108 steps (corresponding to 6 floors).	Other: energy conservation technique; During the session of stair climbing, patients will perform a break at least of 5 seconds every 3 steps.
OTHER: Control session; Patients will perform one session of stair climbing of 108 steps (corresponding to 6 floors).	Other: control session; Patients will realize one session of stair climbing at their own pace

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in time required for the patient to climb the 6 floors	Difference in time (seconds) will be evaluated using a stopwatch	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	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	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	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	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.	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	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	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.

Collaborators and Investigators

• Sponsor: Groupe Hospitalier du Havre

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 23, 2018
• Primary Completion (ACTUAL): March 29, 2019
• Study Completion (ACTUAL): March 29, 2019

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (ACTUAL): June 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: rehabilitation; COPD; stair climbing; daily activity
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2018-A00566-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available after publication. Please contact Guillaume Prieur at gprieur.kine@gmail.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No