Oxygen Consumption in Post-stroke Patients During Various Walking Activities Compared to Healthy Controls

Cerebrovascular Accident Clinical Trial

— STROXCO  

Official title:

Oxygen Consumption in Post-stroke Patients During Various Walking Activities Compared to Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05477238
• Other study ID #: 87RI22_0005 (STROXCO)
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

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