Back to resultsDescription of Physical Activity Effect on Neuromuscular Fatigue of Older People (ACTIFS-AGE)
Primary Purpose
Aging, Fatigue
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires completion
Isometric forces
Energy cost
Sponsored by
About this trial
This is an interventional prevention trial for Aging focused on measuring cardiovascular function, neuromuscular function, V02max
Eligibility Criteria
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.
Sites / Locations
- Chu de Saint-EtienneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Young, Active group
Young, sedentary group
Old, Active group
Old sedentary group
Very old, Active group
Very old sedentary group
Arm Description
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
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.
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
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.
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
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
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
Cardiac variability(ms)
24-hour measurement with an ECG holter for 24 hours.
Muscle oxygenation (%)
This is measured by a NIRS20 (near infrared spectroscopy, Oxysoft, Artinis, TheNetherlands)
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.
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.
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.
Maximal oxygen consumption (VO2max) during an effort test on a cycloergometer
Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire
Score from 0 to 52
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.
Full Information
NCT ID
NCT05413590
First Posted
February 10, 2022
Last Updated
July 18, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT05413590
Brief Title
Description of Physical Activity Effect on Neuromuscular Fatigue of Older People
Acronym
ACTIFS-AGE
Official Title
Description of Physical Activity Effect on Neuromuscular Fatigue of Older People
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 8, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Fatigue
Keywords
cardiovascular function, neuromuscular function, V02max
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Young, Active group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Young, sedentary group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Old, Active group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Old sedentary group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Very old, Active group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Very old sedentary group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaires completion
Intervention Description
Cognitive tests, completing questionnaires, balance test, measuring cardiac variability and post-ischemic hyperemia. Assessments of neuromuscular function on a semi-recumbent ergometric bicycle.
Intervention Type
Other
Intervention Name(s)
Isometric forces
Intervention Description
Measurement of the maximum isometric forces of the knee flexors, the plantar flexors of the ankle and the grip strength of the hand.
Intervention Type
Other
Intervention Name(s)
Energy cost
Intervention Description
Measurement of feet pressure and measurement of the energy cost. Maximum test on an endocycle (classic) to determine VO2max.
Primary Outcome Measure Information:
Title
Maximal voluntary contraction (MVC) of the knee extensor muscle measurement
Description
Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle measured before and after an incremental test on a bicycle ergometer
Time Frame
At 48 hours
Secondary Outcome Measure Information:
Title
Voluntary activation measurement (%)
Description
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.
Time Frame
At 48 hours
Title
Maximal voluntary contraction (MVC) of the plantar flexor muscle measurement
Description
Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle measured before and after an incremental test on a bicycle ergometer
Time Frame
At 48 hours
Title
Maximal voluntary contraction (MVC) of the hand grip measurement
Description
Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle measured before and after an incremental test on a bicycle ergometer
Time Frame
At 48 hours
Title
Cardiac variability(ms)
Description
24-hour measurement with an ECG holter for 24 hours.
Time Frame
At 48 hours
Title
Muscle oxygenation (%)
Description
This is measured by a NIRS20 (near infrared spectroscopy, Oxysoft, Artinis, TheNetherlands)
Time Frame
At 48 hours
Title
Balance test (s)
Description
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.
Time Frame
At 48 hours
Title
Test of Get-up-and-Go (s)
Description
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.
Time Frame
At 48 hours
Title
Reaction force on the ground for each step (N)
Description
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.
Time Frame
At 72 hours
Title
Maximal oxygen consumption (VO2max) during an effort test on a cycloergometer
Time Frame
At 72 hours
Title
Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire
Description
Score from 0 to 52
Time Frame
At inclusion
Title
Quality of life via the SF-36 questionnaire
Description
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.
Time Frame
At inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LEONARD FEASSON, PHD
Phone
04 77 12 03 83
Ext
+33
Email
leonard.feasson@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
DIANA RIMAUD
Phone
04 77 12 04 67
Ext
+33
Email
diana.rimaud@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LEONARD FEASSON, PHD
Organizational Affiliation
Centre Hospitalier Universitaire de Saint Etienne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guillaume MILLET, PhD
Organizational Affiliation
UNIVERSITE DE SAINT ETIENNE
Official's Role
Study Chair
Facility Information:
Facility Name
Chu de Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Léonard FEASSON, MD PhD
First Name & Middle Initial & Last Name & Degree
Clément FOSCHIA, MD
First Name & Middle Initial & Last Name & Degree
David HUPIN, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Description of Physical Activity Effect on Neuromuscular Fatigue of Older People
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