search
Back to results

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

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
walking tasks
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cerebrovascular Accident focused on measuring Stroke, Oxygen consumption, physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Limoges university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Cerebrovascular Accident

healthy volunteer

Arm Description

Stroke patients will perform 2 walking tests indoors and outdoors wearing a gas exchange analyzer, an accelerometer and a heart rate monitor meter

Healthy volunteers patients will perform 2 walking tests indoors and outdoors wearing a gas exchange analyzer, an accelerometer and a heart rate monitor meter

Outcomes

Primary Outcome Measures

Oxygen consumption measurement
Oxygen consumption by indirect calorimetry (respiratory gas exchange analyzer: Metamax) expressed in mL.min-1.kg-1
Oxygen consumption measurement
Oxygen consumption by indirect calorimetry (respiratory gas exchange analyzer: Metamax) expressed in mL.min-1.kg-1

Secondary Outcome Measures

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

Full Information

First Posted
June 23, 2022
Last Updated
July 20, 2023
Sponsor
University Hospital, Limoges
search

1. Study Identification

Unique Protocol Identification Number
NCT05477238
Brief Title
Oxygen Consumption in Post-stroke Patients During Various Walking Activities Compared to Healthy Controls
Acronym
STROXCO
Official Title
Oxygen Consumption in Post-stroke Patients During Various Walking Activities Compared to Healthy Controls
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 7, 2022 (Actual)
Primary Completion Date
June 26, 2023 (Actual)
Study Completion Date
June 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
Stroke, Oxygen consumption, physical activity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Monocentric, cross-sectional and comparative study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cerebrovascular Accident
Arm Type
Experimental
Arm Description
Stroke patients will perform 2 walking tests indoors and outdoors wearing a gas exchange analyzer, an accelerometer and a heart rate monitor meter
Arm Title
healthy volunteer
Arm Type
Other
Arm Description
Healthy volunteers patients will perform 2 walking tests indoors and outdoors wearing a gas exchange analyzer, an accelerometer and a heart rate monitor meter
Intervention Type
Procedure
Intervention Name(s)
walking tasks
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oxygen consumption measurement
Description
Oxygen consumption by indirect calorimetry (respiratory gas exchange analyzer: Metamax) expressed in mL.min-1.kg-1
Time Frame
Day 1
Title
Oxygen consumption measurement
Description
Oxygen consumption by indirect calorimetry (respiratory gas exchange analyzer: Metamax) expressed in mL.min-1.kg-1
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Walking speed measurement
Description
Average walking speed measured (distance walked/total time) during different travel activities
Time Frame
Day 1
Title
Walking speed measurement
Description
Average walking speed measured (distance walked/total time) during different travel activities
Time Frame
Day 7
Title
Cardiac frequency measurement
Description
Average heart rate during activity measured by heart rate meter in bpm
Time Frame
Day 1
Title
Cardiac frequency measurement
Description
Average heart rate during activity measured by heart rate meter in bpm
Time Frame
Day 7
Title
Perception of effort
Description
Perception of effort by the Borg scale during the last minute of the movement activity
Time Frame
Day 1
Title
Perception of effort
Description
Perception of effort by the Borg scale during the last minute of the movement activity
Time Frame
Day 7
Title
Total energy expenditure
Description
Total energy expenditure during each movement activity estimated by an Actigraph GT3X placed at the healthy ankle
Time Frame
Day 1
Title
Total energy expenditure
Description
Total energy expenditure during each movement activity estimated by an Actigraph GT3X placed at the healthy ankle
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Limoges university hospital
City
Limoges
ZIP/Postal Code
87042
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs