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

Sponsor
University Hospital, Limoges (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05477238
Collaborator
(none)
60
2
2
10
30
3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: walking tasks
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Monocentric, cross-sectional and comparative studyMonocentric, cross-sectional and comparative study
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Oxygen Consumption in Post-stroke Patients During Various Walking Activities Compared to Healthy Controls
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Oxygen consumption measurement [Day 1]

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

  2. Oxygen consumption measurement [Day 7]

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

Secondary Outcome Measures

  1. Walking speed measurement [Day 1]

    Average walking speed measured (distance walked/total time) during different travel activities

  2. Walking speed measurement [Day 7]

    Average walking speed measured (distance walked/total time) during different travel activities

  3. Cardiac frequency measurement [Day 1]

    Average heart rate during activity measured by heart rate meter in bpm

  4. Cardiac frequency measurement [Day 7]

    Average heart rate during activity measured by heart rate meter in bpm

  5. Perception of effort [Day 1]

    Perception of effort by the Borg scale during the last minute of the movement activity

  6. Perception of effort [Day 7]

    Perception of effort by the Borg scale during the last minute of the movement activity

  7. Total energy expenditure [Day 1]

    Total energy expenditure during each movement activity estimated by an Actigraph GT3X placed at the healthy ankle

  8. Total energy expenditure [Day 7]

    Total energy expenditure during each movement activity estimated by an Actigraph GT3X placed at the healthy ankle

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Limoges university hospital Limoges France 87042
2 Limoges University hospital Limoges France 87042

Sponsors and Collaborators

  • University Hospital, Limoges

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT05477238
Other Study ID Numbers:
  • 87RI22_0005 (STROXCO)
First Posted:
Jul 28, 2022
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Limoges
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022