NCT05477238

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 7, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2023

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

June 23, 2022

Last Update Submit

July 20, 2023

Conditions

Keywords

StrokeOxygen consumptionphysical activity

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

EXPERIMENTAL

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

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

Procedure: walking tasks

Interventions

walking tasksPROCEDURE

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.

Cerebrovascular Accidenthealthy volunteer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Monocentric, cross-sectional and comparative study
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

Locations