Description of Physical Activity Effect on Neuromuscular Fatigue of Older People (ACTIFS-AGE)

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.

Study Overview

• Status: Recruiting
• Conditions: Fatigue; Aging
• Intervention / Treatment: Other: Questionnaires completion; Other: Isometric forces; Other: Energy cost

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LEONARD FEASSON, PHD; Phone Number: +33 04 77 12 03 83; Email: leonard.feasson@chu-st-etienne.fr
• Study Contact Backup: Name: DIANA RIMAUD; Phone Number: +33 04 77 12 04 67; Email: diana.rimaud@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France, 42055
    • Recruiting
    • Chu de Saint-Etienne
    • Sub-Investigator: David HUPIN, MD
    • Sub-Investigator: Clément FOSCHIA, MD
    • Sub-Investigator: Philippe BOIRON, MD
    • Principal Investigator: Léonard FEASSON, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Young, Active group; From 18 to 35 years old. The subjects will be considered as active if after completion of the Global Physical Activity Questionnaire (GPAQ), the subjects count: at least 20 minutes of vigorous physical activity per day for 3 or more days per week OR; at least 30 minutes of moderate physical activity or walking per day for 5 or more days per week OR; At least 5 days of walking and moderate or vigorous physical activity, reaching a minimum of 600 Metabolic Equivalent of Task (MET)-minutes per week	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.; Other: 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.; Other: Energy cost; Measurement of feet pressure and measurement of the energy cost. Maximum test on an endocycle (classic) to determine VO2max.
Active Comparator: Young, sedentary group; From 18 to 35 years old. Subjects who are below these thresholds will be considered as sedentary. To avoid including a subject who recently changed his lifestyle (sedentary becoming active or vice versa), the investigator will ensure the subject kept this physical activity level (expressed using the GPAQ) constant for the last 5 years.	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.; Other: 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.; Other: Energy cost; Measurement of feet pressure and measurement of the energy cost. Maximum test on an endocycle (classic) to determine VO2max.
Active Comparator: Old, Active group; From 65 to 80 years old. The subjects will be considered as active if after completion of the Global Physical Activity Questionnaire (GPAQ), the subjects count: at least 20 minutes of vigorous physical activity per day for 3 or more days per week OR; at least 30 minutes of moderate physical activity or walking per day for 5 or more days per week OR; At least 5 days of walking and moderate or vigorous physical activity, reaching a minimum of 600 MET-minutes per week	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.; Other: 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.; Other: Energy cost; Measurement of feet pressure and measurement of the energy cost. Maximum test on an endocycle (classic) to determine VO2max.
Active Comparator: Old sedentary group; From 65 to 80 years old. Subjects who are below these thresholds will be considered as sedentary. To avoid including a subject who recently changed his lifestyle (sedentary becoming active or vice versa), the investigator will ensure the subject kept this physical activity level (expressed using the GPAQ) constant for the last 5 years.	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.; Other: 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.; Other: Energy cost; Measurement of feet pressure and measurement of the energy cost. Maximum test on an endocycle (classic) to determine VO2max.
Active Comparator: Very old, Active group; From 81 years old. The subjects will be considered as active if after completion of the Global Physical Activity Questionnaire (GPAQ), the subjects count: at least 20 minutes of vigorous physical activity per day for 3 or more days per week OR; at least 30 minutes of moderate physical activity or walking per day for 5 or more days per week OR; At least 5 days of walking and moderate or vigorous physical activity, reaching a minimum of 600 MET-minutes per week	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.; Other: 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.; Other: Energy cost; Measurement of feet pressure and measurement of the energy cost. Maximum test on an endocycle (classic) to determine VO2max.
Active Comparator: Very old sedentary group; From 81 years old. Subjects who are below these thresholds will be considered as sedentary. To avoid including a subject who recently changed his lifestyle (sedentary becoming active or vice versa), the investigator will ensure the subject kept this physical activity level (expressed using the GPAQ) constant for the last 5 years.	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.; Other: 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.; Other: Energy cost; Measurement of feet pressure and measurement of the energy cost. Maximum test on an endocycle (classic) to determine VO2max.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Cardiac variability(ms)	24-hour measurement with an ECG holter for 24 hours.	At 48 hours
Muscle oxygenation (%)	This is measured by a NIRS20 (near infrared spectroscopy, Oxysoft, Artinis, TheNetherlands)	At 48 hours
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
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
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
Maximal oxygen consumption (VO2max) during an effort test on a cycloergometer		At 72 hours
Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire	Score from 0 to 52	At inclusion
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: LEONARD FEASSON, PHD, Centre Hospitalier Universitaire de Saint Etienne; Study Chair: Guillaume MILLET, PhD, UNIVERSITE DE SAINT ETIENNE

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 8, 2025

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: cardiovascular function; neuromuscular function; V02max
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 21CH033; ANSM (Other Identifier: 2025-A02220-49)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No