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Evaluating and Monitoring Physical Fatigue While Performing Functional Activities

V

Vrije Universiteit Brussel

Status

Completed

Conditions

Stroke
Fatigue
Sarcopenia

Treatments

Other: Performance test

Study type

Interventional

Funder types

Other

Identifiers

NCT06513377
RevalExo2

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 3 patient groups

People post-stroke
Experimental group
Description:
The intervention includes a stress test that induces progressive feelings of fatigue.
Treatment:
Other: Performance test
Older adults with sarcopenia
Experimental group
Description:
The intervention includes a stress test that induces progressive feelings of fatigue.
Treatment:
Other: Performance test
Healthy individuals
Experimental group
Description:
The intervention includes a stress test that induces progressive feelings of fatigue.
Treatment:
Other: Performance test

Trial contacts and locations

1

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Central trial contact

David Beckwée, PhD; Reinhard Claeys, MSc

Data sourced from clinicaltrials.gov

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