Evaluating and Monitoring Physical Fatigue While Performing Functional Activities

NCT06513377 | Completed

• 1 other identifier: RevalExo2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Sarcopenia; Fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Changes in muscle activity throughout the protocol execution

  Collected during all measurement moments (2-12 weeks).

• Changes in heart rate (variability) throughout the protocol execution

  Collected during all measurement moments (2-12 weeks).

• Changes in oxygen saturation throughout the protocol execution

  Collected during all measurement moments (2-12 weeks).

• Changes in electrodermal activity throughout the protocol execution

  Collected during all measurement moments (2-12 weeks).

• Changes in muscle force myography throughout the protocol execution

  Collected during all measurement moments (2-12 weeks).

Study Arms (3)

People post-stroke

EXPERIMENTAL

The intervention includes a stress test that induces progressive feelings of fatigue.

Other: Performance test

Older adults with sarcopenia

EXPERIMENTAL

The intervention includes a stress test that induces progressive feelings of fatigue.

Other: Performance test

Healthy individuals

EXPERIMENTAL

The intervention includes a stress test that induces progressive feelings of fatigue.

Other: Performance test

Interventions

Performance test OTHER

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.

Healthy individuals; Older adults with sarcopenia; People post-stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• \> 65 years old
• Grip strength: \< 27 kg (man) or \< 16 kg (woman)
• Be mobile independently
• 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:
• \> 18 years old
• Healthy physical and medical condition
• Physical injury or disorder that doesn't allow good physical performance

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

Brubotics Rehabilitation Research Center

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Stroke; Sarcopenia; Fatigue

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 22, 2024
• Study Start: March 20, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: January 23, 2026

Record last verified: 2025-09

Locations

BE (1)