Oxygen Consumption in Post-stroke Patients During Various Walking Activities Compared to Healthy Controls
STROXCO
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2022
CompletedFirst Posted
Study publicly available on registry
July 28, 2022
CompletedStudy Start
First participant enrolled
September 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2023
CompletedJuly 21, 2023
July 1, 2023
10 months
June 23, 2022
July 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (8)
Walking speed measurement
Day 1
Walking speed measurement
Day 7
Cardiac frequency measurement
Day 1
Cardiac frequency measurement
Day 7
Perception of effort
Day 1
- +3 more secondary outcomes
Study Arms (2)
Cerebrovascular Accident
EXPERIMENTALStroke patients will perform 2 walking tests indoors and outdoors wearing a gas exchange analyzer, an accelerometer and a heart rate monitor meter
healthy volunteer
OTHERHealthy volunteers patients will perform 2 walking tests indoors and outdoors wearing a gas exchange analyzer, an accelerometer and a heart rate monitor meter
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Limoges university hospital
Limoges, 87042, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2022
First Posted
July 28, 2022
Study Start
September 7, 2022
Primary Completion
June 26, 2023
Study Completion
June 26, 2023
Last Updated
July 21, 2023
Record last verified: 2023-07