Cerebrovascular AccidentSTROXCONCT05477238
Oxygen Consumption in Post-stroke Patients During Various Walking Activities Compared to Healthy Controls
A study testing walking tasks in people with Cerebrovascular Accident, run by University Hospital, Limoges at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- walking tasks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2022to 26 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cerebrovascular Accident
- Being tested
- walking tasks
- Keywords
- Stroke, Oxygen consumption, physical activity
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking tasksProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cerebrovascular Accident | Experimental | Stroke patients will perform 2 walking tests indoors and outdoors wearing a gas exchange analyzer, an accelerometer and a heart rate monitor meter Receives: Procedure: walking tasks |
| healthy volunteer | Other | Healthy volunteers patients will perform 2 walking tests indoors and outdoors wearing a gas exchange analyzer, an accelerometer and a heart rate monitor meter Receives: Procedure: walking tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption measurement
Oxygen consumption by indirect calorimetry (respiratory gas exchange analyzer: Metamax) expressed in mL.min-1.kg-1
Measured: Day 1
Oxygen consumption measurement
Oxygen consumption by indirect calorimetry (respiratory gas exchange analyzer: Metamax) expressed in mL.min-1.kg-1
Measured: Day 7
Secondary outcomes (8)
Walking speed measurement
Average walking speed measured (distance walked/total time) during different travel activities
Measured: Day 1
Walking speed measurement
Average walking speed measured (distance walked/total time) during different travel activities
Measured: Day 7
Cardiac frequency measurement
Average heart rate during activity measured by heart rate meter in bpm
Measured: Day 1
Cardiac frequency measurement
Average heart rate during activity measured by heart rate meter in bpm
Measured: Day 7
Perception of effort
Perception of effort by the Borg scale during the last minute of the movement activity
Measured: Day 1
Perception of effort
Perception of effort by the Borg scale during the last minute of the movement activity
Measured: Day 7
Total energy expenditure
Total energy expenditure during each movement activity estimated by an Actigraph GT3X placed at the healthy ankle
Measured: Day 1
Total energy expenditure
Total energy expenditure during each movement activity estimated by an Actigraph GT3X placed at the healthy ankle
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start7 Sep 2022
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, cross-sectional and comparative study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477238
- Sponsor's protocol ID
- 87RI22_0005 (STROXCO)
- Acronym
- STROXCO
- Status last verified
- Jul 2023
- First submitted
- 23 Jun 2022
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guediri A, Compagnat M, Poyet A, Daviet JC, Mandigout S. Relationships between oxygen consumption, heart rate, perceived exertion, and walking speed during ecological walking tasks in stroke survivors and healthy controls: a secondary cross-sectional analysis. Physiother Theory Pract. 2026 Aug 18:1-13. doi: 10.1080/09593985.2026.2719838. Online ahead of print.
PubMed 42610674Guediri A, Compagnat M, Poyet A, Daviet JC, Mandigout S. Energy Cost of Walking in Relation to Impairment and Functional Independence After Stroke: The Role of Walking Speed. Physiother Res Int. 2026 Jul;31(3):e70287. doi: 10.1002/pri.70287.
PubMed 42446085Guediri A, Compagnat M, Baillargeat M, Firmin L, Daviet JC, Mandigout S. Wearable ankle activity monitor overestimates energy expenditure during ecological walking tasks in individuals with stroke and healthy adults. Int J Rehabil Res. 2026 Sep 1;49(3):197-205. doi: 10.1097/MRR.0000000000000708. Epub 2026 Jul 28.
PubMed 42112845
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Consumption in Post-stroke Patients During Various Walking Activities Compared to Healthy Controls
- ClinicalTrials.gov ID
- NCT05477238
- Acronym / sponsor ID
- STROXCO / 87RI22_0005 (STROXCO)
- Conditions
- Cerebrovascular Accident
- Keywords
- Stroke, Oxygen consumption, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric, cross-sectional and comparative study
| Arm | Type | Receives |
|---|---|---|
| Cerebrovascular Accident | Experimental | Procedure: walking tasksStroke patients will perform 2 walking tests indoors and outdoors wearing a gas exchange analyzer, an accelerometer and a heart rate monitor meter |
| healthy volunteer | Other | Procedure: walking tasksHealthy volunteers patients will perform 2 walking tests indoors and outdoors wearing a gas exchange analyzer, an accelerometer and a heart rate monitor meter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >=18 years
- Able to give consent
- Not under guardianship or curatorship
- Enrolled in the French social security system
- Stroke confirmed by brain imaging
Key exclusion criteria (3 listed)
- Cerebrovascular accident group - Severe cognitive impairment (MoCA < 18)
- Presence of contraindication to physical activity: unstable diabetes, unstable hypertension, unstable angina, intra-cardiac thrombus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walking tasksThe 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. | Procedure or surgery | Cerebrovascular Accident, healthy volunteer |
Primary outcome
Oxygen consumption measurement
Time frame: Day 1
Oxygen consumption by indirect calorimetry (respiratory gas exchange analyzer: Metamax) expressed in mL.min-1.kg-1
Oxygen consumption measurement
Time frame: Day 7
Oxygen consumption by indirect calorimetry (respiratory gas exchange analyzer: Metamax) expressed in mL.min-1.kg-1
8 secondary outcomes
Walking speed measurement
Time frame: Day 1
Walking speed measurement
Time frame: Day 7
Cardiac frequency measurement
Time frame: Day 1
Cardiac frequency measurement
Time frame: Day 7
Perception of effort
Time frame: Day 1
Perception of effort
Time frame: Day 7
Total energy expenditure
Time frame: Day 1
Total energy expenditure
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Derived from this study: PubMed 42610674Guediri A, Compagnat M, Poyet A, Daviet JC, Mandigout S. Relationships between oxygen consumption, heart rate, perceived exertion, and walking speed during ecological walking tasks in stroke survivors and healthy controls: a secondary cross-sectional analysis. Physiother Theory Pract. 2026 Aug 18:1-13. doi: 10.1080/09593985.2026.2719838. Online ahead of print.
- Derived from this study: PubMed 42446085Guediri A, Compagnat M, Poyet A, Daviet JC, Mandigout S. Energy Cost of Walking in Relation to Impairment and Functional Independence After Stroke: The Role of Walking Speed. Physiother Res Int. 2026 Jul;31(3):e70287. doi: 10.1002/pri.70287.
- Derived from this study: PubMed 42112845Guediri A, Compagnat M, Baillargeat M, Firmin L, Daviet JC, Mandigout S. Wearable ankle activity monitor overestimates energy expenditure during ecological walking tasks in individuals with stroke and healthy adults. Int J Rehabil Res. 2026 Sep 1;49(3):197-205. doi: 10.1097/MRR.0000000000000708. Epub 2026 Jul 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking tasks in people with Cerebrovascular Accident, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen consumption measurement (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05477238, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.