Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Energy Conservation Technique in COPD Patients (UpstAIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03564028
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier du Havre

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: energy conservation technique Other: control session Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Effects of Energy Conservation Technique During Stair Climbing in COPD Patients : a Randomized Controlled Trial
Actual Study Start Date : July 23, 2018
Actual Primary Completion Date : March 29, 2019
Actual Study Completion Date : March 29, 2019

Resource links provided by the National Library of Medicine


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.

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 time (seconds) will be evaluated using a stopwatch

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

  3. 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 inspiratory capacity (Liters) will be measured using a portable spirometer

  4. 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 Cardiac Frequence (bpm) using a pulse oximetry

  5. 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 Oxygen Saturation

  6. 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. ]
    Muscle oxygenation (arbitrary unit) will be evaluated using Near-infrared spectroscopy technology.

  7. 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 tidal volume (Liters) will be measured breath-by-breath using a portable spirometer

  8. 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. ]
    Difference in muscular fatigue using Modified Borg Scale (0 - 10 points) 0=no muscular fatigue ; 10 = maximal effort



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564028


Locations
Layout table for location information
France
Groupe Hospitalier du Havre
Le Havre, Normandie, France, 76290
Sponsors and Collaborators
Groupe Hospitalier du Havre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Groupe Hospitalier du Havre
ClinicalTrials.gov Identifier: NCT03564028    
Other Study ID Numbers: 2018-A00566-49
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available after publication. Please contact Guillaume Prieur at gprieur.kine@gmail.com

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Groupe Hospitalier du Havre:
COPD
daily activity
stair climbing
rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases