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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05477238
Other study ID # 87RI22_0005 (STROXCO)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 7, 2022
Est. completion date June 26, 2023

Study information

Verified date July 2023
Source University Hospital, Limoges
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Stroke is major public health issue. The investigators recommend post-stroke patients to practice physical activity. Nevertheless, the recommendations are not widely respected due to the intensity of exercises. Oxygen consumption is a parameter to assess the intensity of physical activity. in this sense, we want to measure the oxygen consumption during various walking tasks compared to healthy controls.


Description:

Stroke is defined as an interruption of blood circulation in the brain. The treatments are in first time medical in emergency. Then, the patient will start his rehabilitation with several contributors. At this time, it will recommend physical activity to patients. Regardless of the all benefits of physical activity, it will help patient to avoid a second stroke. The investigators have the recommendations of the high authority of health in physical activity for stroke population. It recommends to practice around 20 to 60 minutes daily of physical activity with moderate effort intensity. Oxygen consumption is a parameter of effort intensity of physical activity measured in ml O2/kg/min. Currently, the investigators have the compendium of physical activity (PA). it allows us to classify PA according to effort intensity. And so, an activity with a moderate effort intensity is an activity between 3 and 5.9 metabolic equivalent task (MET). Note that 1 MET is 3.5 ml/O2/Kg. Nevertheless, this compendium does not correspond to post-stroke individuals. As consequences, Low intensity exercise as described in guidelines might be at a moderate intensity level for stroke survivors. Hence, the investigators want to assess the oxygen consumption of post-stroke individuals during various walking tasks and compare it to healthy controls.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 26, 2023
Est. primary completion date June 26, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Common to both groups: - Age >=18 years - Able to give consent - Not under guardianship or curatorship - Enrolled in the French social security system Specific to the cerebrovascular accident Group: - Stroke confirmed by brain imaging - Able to walk stairs without human assistance (modified Functional Ambulation Classification >= 6) Healthy Group Specific: - Individuals matched to stroke individuals on age sex and BMI. Exclusion Criteria: Cerebrovascular accident group - Severe cognitive impairment (MoCA < 18) Common to both groups: - Presence of contraindication to physical activity: unstable diabetes, unstable hypertension, unstable angina, intra-cardiac thrombus.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
walking tasks
The experiment will be divided in two sessions. In the first session, the participant/healthy volunteers will do 3 walking tasks (over ground walking/ climbing up, down stairs). In the second session, the participant will walk outside in front of the hospital (walking on a slope, walking down, walking on uneven ground). All those tasks will be done while wearing a gas exchange analyzer, accelerometer and a heart rate meter.

Locations

Country Name City State
France Limoges university hospital Limoges

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oxygen consumption measurement Oxygen consumption by indirect calorimetry (respiratory gas exchange analyzer: Metamax) expressed in mL.min-1.kg-1 Day 1
Primary Oxygen consumption measurement Oxygen consumption by indirect calorimetry (respiratory gas exchange analyzer: Metamax) expressed in mL.min-1.kg-1 Day 7
Secondary Walking speed measurement Average walking speed measured (distance walked/total time) during different travel activities Day 1
Secondary Walking speed measurement Average walking speed measured (distance walked/total time) during different travel activities Day 7
Secondary Cardiac frequency measurement Average heart rate during activity measured by heart rate meter in bpm Day 1
Secondary Cardiac frequency measurement Average heart rate during activity measured by heart rate meter in bpm Day 7
Secondary Perception of effort Perception of effort by the Borg scale during the last minute of the movement activity Day 1
Secondary Perception of effort Perception of effort by the Borg scale during the last minute of the movement activity Day 7
Secondary Total energy expenditure Total energy expenditure during each movement activity estimated by an Actigraph GT3X placed at the healthy ankle Day 1
Secondary Total energy expenditure Total energy expenditure during each movement activity estimated by an Actigraph GT3X placed at the healthy ankle Day 7
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