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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03564028
Other study ID # 2018-A00566-49
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 23, 2018
Est. completion date March 29, 2019

Study information

Verified date April 2019
Source Groupe Hospitalier du Havre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date March 29, 2019
Est. primary completion date March 29, 2019
Accepts healthy volunteers No
Gender All
Age group 35 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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 realize one session of stair climbing at their own pace

Locations

Country Name City State
France Groupe Hospitalier du Havre Le Havre Normandie

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier du Havre

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
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