Evaluating and Monitoring Physical Fatigue While Performing Functional Activities

Fatigue is a critical health parameter in older adults and stroke patients and is associated with negative health outcomes. Current assessment tools predominantly focus on walking related fatigue, neglecting other activities of daily living (ADLs). This study aims to fill this gap by developing a standardized, laboratory-based fatigue protocol that includes a broader range of ADLs, providing a more comprehensive fatigue assessment that's in line with the WHO vision of healthy ageing.

The aim of this study is to evaluate a lab-based fatigue protocol and to unravel the relationship between physiological or movement data and perceived fatigue.

Participants will take part in three separate measurement moments, during which they will execute a performance task that induces fatigue. In addition, relevant sensors will be used to collect meaningful data.

Study Overview

• Status: Completed
• Conditions: Stroke; Fatigue; Sarcopenia
• Intervention / Treatment: Other: Performance test

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels Capital
    • Jette, Brussels Capital, Belgium, 1090
      • Brubotics Rehabilitation Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Stroke survivors:

Inclusion Criteria:

• > 18 years old
• ≥ 3 months ago stroke diagnosis
• FAC levels 3-5

Exclusion Criteria:

• Severe problems with speech or memory which prevents the participant to understand or follow instruction
• Co-morbidities that could influence the task execution and collected data

Older adults with sarcopenia:

Inclusion:

• > 65 years old
• Grip strength: < 27 kg (man) or < 16 kg (woman)
• Be mobile independently

Exclusion:

• Severe problems with speech or memory which prevents the participant to understand or follow instruction
• Co-morbidities that could influence the task execution and collected data

Healthy individuals:

Inclusion:

• > 18 years old
• Healthy physical and medical condition

Exclusion:

• Physical injury or disorder that doesn't allow good physical performance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: People post-stroke; The intervention includes a stress test that induces progressive feelings of fatigue.	Other: Performance test; The participant will be asked to execute a protocol in the movement lab that induces progressive feelings of fatigue. This protocol includes a sequence of relevant functional activities, such as stair walking, slope walking, crouching, walking different path shapes. During this execution the Ratings of Perceived Exertion will be questioned, and simultaneously physiological and movement data will be collected.
Experimental: Older adults with sarcopenia; The intervention includes a stress test that induces progressive feelings of fatigue.	Other: Performance test; The participant will be asked to execute a protocol in the movement lab that induces progressive feelings of fatigue. This protocol includes a sequence of relevant functional activities, such as stair walking, slope walking, crouching, walking different path shapes. During this execution the Ratings of Perceived Exertion will be questioned, and simultaneously physiological and movement data will be collected.
Experimental: Healthy individuals; The intervention includes a stress test that induces progressive feelings of fatigue.	Other: Performance test; The participant will be asked to execute a protocol in the movement lab that induces progressive feelings of fatigue. This protocol includes a sequence of relevant functional activities, such as stair walking, slope walking, crouching, walking different path shapes. During this execution the Ratings of Perceived Exertion will be questioned, and simultaneously physiological and movement data will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Ratings of Perceived Exertion throughout the protocol execution	The subjective feelings of fatigue will be evaluated through the Ratings of Perceived Exertion. This will be expressed verbally by the participant throughout the execution of the protocol.	Collected during all measurement moments (2-12 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in muscle activity throughout the protocol execution	Muscle activity data (EMG) will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.	Collected during all measurement moments (2-12 weeks).
Changes in heart rate (variability) throughout the protocol execution	Cardiorespiratory data (Heart rate) will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.	Collected during all measurement moments (2-12 weeks).
Changes in oxygen saturation throughout the protocol execution	Oxygen saturation data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.	Collected during all measurement moments (2-12 weeks).
Changes in electrodermal activity throughout the protocol execution	Electrodermal activity data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.	Collected during all measurement moments (2-12 weeks).
Changes in muscle force myography throughout the protocol execution	Muscle force myography data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.	Collected during all measurement moments (2-12 weeks).
Changes in skin temperature throughout the protocol execution	Skin temperature data (degrees Celsius) will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.	Collected during all measurement moments (2-12 weeks).
Changes in motion data throughout the protocol execution	IMU data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.	Collected during all measurement moments (2-12 weeks).
Changes in plantar pressure throughout the protocol execution	Plantar pressure distribution data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.	Collected during all measurement moments (2-12 weeks).
Changes in gaze patter throughout the protocol execution	Eye tracking data will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.	Collected during all measurement moments (2-12 weeks).
Changes in joint angles throughout the protocol execution	Kinematic data (degrees) will be collected continuously throughout the protocol execution. Data acquisition will occur in a synchronized manner.	Collected during all measurement moments (2-12 weeks).

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Actual): October 15, 2025
• Study Completion (Actual): October 15, 2025

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Fatigue; Sarcopenia
• Other Study ID Numbers: RevalExo2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No