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

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.

Study Overview

• Status: Completed
• Conditions: Cerebrovascular Accident
• Intervention / Treatment: Procedure: walking tasks

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • Limoges university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cerebrovascular Accident; Stroke patients will perform 2 walking tests indoors and outdoors wearing a gas exchange analyzer, an accelerometer and a heart rate monitor meter	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.
Other: healthy volunteer; Healthy volunteers patients will perform 2 walking tests indoors and outdoors wearing a gas exchange analyzer, an accelerometer and a heart rate monitor meter	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen consumption measurement	Oxygen consumption by indirect calorimetry (respiratory gas exchange analyzer: Metamax) expressed in mL.min-1.kg-1	Day 1
Oxygen consumption measurement	Oxygen consumption by indirect calorimetry (respiratory gas exchange analyzer: Metamax) expressed in mL.min-1.kg-1	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking speed measurement	Average walking speed measured (distance walked/total time) during different travel activities	Day 1
Walking speed measurement	Average walking speed measured (distance walked/total time) during different travel activities	Day 7
Cardiac frequency measurement	Average heart rate during activity measured by heart rate meter in bpm	Day 1
Cardiac frequency measurement	Average heart rate during activity measured by heart rate meter in bpm	Day 7
Perception of effort	Perception of effort by the Borg scale during the last minute of the movement activity	Day 1
Perception of effort	Perception of effort by the Borg scale during the last minute of the movement activity	Day 7
Total energy expenditure	Total energy expenditure during each movement activity estimated by an Actigraph GT3X placed at the healthy ankle	Day 1
Total energy expenditure	Total energy expenditure during each movement activity estimated by an Actigraph GT3X placed at the healthy ankle	Day 7

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Actual): June 26, 2023
• Study Completion (Actual): June 26, 2023

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; Stroke; Oxygen consumption
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 87RI22_0005 (STROXCO)

Drug and device information, study documents

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