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Completed

NCT Number: NCT05477238

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Limoges university hospital

Limoges, 87042, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

walking tasks

Procedure

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 outcomes

  1. Oxygen consumption measurement

    Time frame: Day 1

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

  2. Oxygen consumption measurement

    Time frame: Day 7

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

Secondary outcomes

  1. Walking speed measurement

    Time frame: Day 1

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

  2. Walking speed measurement

    Time frame: Day 7

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

  3. Cardiac frequency measurement

    Time frame: Day 1

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

  4. Cardiac frequency measurement

    Time frame: Day 7

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

  5. Perception of effort

    Time frame: Day 1

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

  6. Perception of effort

    Time frame: Day 7

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

  7. Total energy expenditure

    Time frame: Day 1

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

  8. Total energy expenditure

    Time frame: Day 7

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

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: STROXCO

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 28, 2022
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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