Clinical trial NCT06513377: Evaluating and Monitoring Physical Fatigue While Performing Functional Activities
Official title: Evaluating and Monitoring Physical Fatigue While Performing Functional Activities
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Sarcopenia
Fatigue
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Changes in the Ratings of Perceived Exertion throughout the protocol execution
timeFrame: Collected during all measurement moments (2-12 weeks).
Secondary outcomes:
measure: Changes in muscle activity throughout the protocol execution
timeFrame: Collected during all measurement moments (2-12 weeks).
measure: Changes in heart rate (variability) throughout the protocol execution
timeFrame: Collected during all measurement moments (2-12 weeks).
measure: Changes in oxygen saturation throughout the protocol execution
timeFrame: Collected during all measurement moments (2-12 weeks).
measure: Changes in electrodermal activity throughout the protocol execution
timeFrame: Collected during all measurement moments (2-12 weeks).
measure: Changes in muscle force myography throughout the protocol execution
timeFrame: Collected during all measurement moments (2-12 weeks).
measure: Changes in skin temperature throughout the protocol execution
timeFrame: Collected during all measurement moments (2-12 weeks).
measure: Changes in motion data throughout the protocol execution
timeFrame: Collected during all measurement moments (2-12 weeks).
measure: Changes in plantar pressure throughout the protocol execution
timeFrame: Collected during all measurement moments (2-12 weeks).
measure: Changes in gaze patter throughout the protocol execution
timeFrame: Collected during all measurement moments (2-12 weeks).
measure: Changes in joint angles throughout the protocol execution
timeFrame: Collected during all measurement moments (2-12 weeks).
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Brubotics Rehabilitation Research Center
state: Brussels
Study officials:
References: