Description of Physical Activity Effect on Neuromuscular Fatigue of Older People

Aging Clinical Trial

— ACTIFS-AGE  

Official title:

Description of Physical Activity Effect on Neuromuscular Fatigue of Older People

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05413590
• Other study ID #: 21CH033
• Secondary ID: ANSM
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2021
• Est. completion date: September 8, 2025

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: LEONARD FEASSON, PHD
• Phone: 04 77 12 03 83
• Email: leonard.feasson[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is a decrease in cardiovascular and neuromuscular functions, which leads to reduced performance with advancing age. Physical activity provides health benefits, prevents and treats cardiovascular and neuromuscular disease. The aim of this project is to describe cardiovascular and neuromuscular function in active and sedentary subjects of different ages.

Description:

With advancing age, there is a decrease in cardiovascular and neuromuscular functions, which leads to reduced performance and increases the likelihood that older people will lose their independence. Physical activity provides health benefits, prevents and treats cardiovascular and neuromuscular disease. Indeed, recent data support the idea that it is fitness level, not age that explains physiological responses to exercise. However, although there are data about how quickly cardiovascular and neuromuscular functions decline throughout life, less is known on the extent physical activity can help mitigate the loss of these functions. The aim of this project is therefore to describe cardiovascular and neuromuscular function in active and sedentary subjects of different ages.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 8, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 to 35 for the young group, between 65 and 80 for the old group and over 80 for the very old group.

• Signed consent for the study obtained

• Subject affiliated or entitled to a social security scheme

Exclusion Criteria:

• Pathology or surgical intervention causing a locomotor disorder

• Neurological, cardiovascular or psychological pathology

• Participants will be excluded if resting or exercise ECG responses show any abnormality, or if resting Heart Rate (HR) > 100 bmp, resting blood pressure > 144 (systolic) / 95 (diastolic) mmHg, pulmonary and or cardiac disease that could affect the health of the participant (arrhythmias and stroke)

• Mini-Mental State Examination score < 20 (>80 years old)

• Significant change in the amount of physical practice over the last 5 years.

Related Conditions & MeSH terms

• Aging
• Fatigue

Intervention

Other:
• Questionnaires completion
Cognitive tests, completing questionnaires, balance test, measuring cardiac variability and post-ischemic hyperemia. Assessments of neuromuscular function on a semi-recumbent ergometric bicycle.
• Isometric forces
Measurement of the maximum isometric forces of the knee flexors, the plantar flexors of the ankle and the grip strength of the hand.
• Energy cost
Measurement of feet pressure and measurement of the energy cost. Maximum test on an endocycle (classic) to determine VO2max.

Locations

Country	Name	City	State
France	Chu de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal voluntary contraction (MVC) of the knee extensor muscle measurement	Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle measured before and after an incremental test on a bicycle ergometer	At 48 hours
Secondary	Voluntary activation measurement (%)	The level of voluntary activation will be determined by the force increment obtained following stimulation performed during a condition of the muscle in a state of maximum contraction.	At 48 hours
Secondary	Maximal voluntary contraction (MVC) of the plantar flexor muscle measurement	Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle measured before and after an incremental test on a bicycle ergometer	At 48 hours
Secondary	Maximal voluntary contraction (MVC) of the hand grip measurement	Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle measured before and after an incremental test on a bicycle ergometer	At 48 hours
Secondary	Cardiac variability(ms)	24-hour measurement with an ECG holter for 24 hours.	At 48 hours
Secondary	Muscle oxygenation (%)	This is measured by a NIRS20 (near infrared spectroscopy, Oxysoft, Artinis, TheNetherlands)	At 48 hours
Secondary	Balance test (s)	This test, performed in unipedal support, consists of asking the subject to hold the unipedal position for as long as possible, on the lower limb of his choice.	At 48 hours
Secondary	Test of Get-up-and-Go (s)	For test of Get-up-and-Go, participants will be asked to stand from a seated position, walk 3 meters at their usual pace, turn around, walk back to the chair, and sit down.; Measured in seconds when performing test.	At 48 hours
Secondary	Reaction force on the ground for each step (N)	First, a maximum pace walking speed and a comfort speed will be measured in a corridor using photoelectric cells. Then, a biomechanical analysis of walking at several speeds (comfort walking, 2.5, 4 and 5.5 km/h) will be performed on an instrumented treadmill (Treadmetrix, Park City, Utah, United States). This treadmill allows the analysis of the reaction forces on the ground during the strides while controlling the speed of the walk. Each step will last approximately 30 seconds.	At 72 hours
Secondary	Maximal oxygen consumption (VO2max) during an effort test on a cycloergometer		At 72 hours
Secondary	Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire	Score from 0 to 52	At inclusion
Secondary	Quality of life via the SF-36 questionnaire	This questionnaire is composed of 12 questions representing the eight most relevant domains to describe and evaluate quality of life. Score ranges from 0 to 100, with a higher score defining a more favorable health state.	At inclusion