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

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Recruiting
CT.gov ID
NCT05413590
Collaborator
(none)
180
1
6
21
8.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaires completion
  • Other: Isometric forces
  • Other: Energy cost
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Description of Physical Activity Effect on Neuromuscular Fatigue of Older People
Actual Study Start Date :
Nov 30, 2021
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Maximal voluntary contraction (MVC) of the knee extensor muscle measurement [At 48 hours]

    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

  1. Voluntary activation measurement (%) [At 48 hours]

    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.

  2. Maximal voluntary contraction (MVC) of the plantar flexor muscle measurement [At 48 hours]

    Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle measured before and after an incremental test on a bicycle ergometer

  3. Maximal voluntary contraction (MVC) of the hand grip measurement [At 48 hours]

    Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle measured before and after an incremental test on a bicycle ergometer

  4. Cardiac variability(ms) [At 48 hours]

    24-hour measurement with an ECG holter for 24 hours.

  5. Muscle oxygenation (%) [At 48 hours]

    This is measured by a NIRS20 (near infrared spectroscopy, Oxysoft, Artinis, TheNetherlands)

  6. Balance test (s) [At 48 hours]

    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.

  7. Test of Get-up-and-Go (s) [At 48 hours]

    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.

  8. Reaction force on the ground for each step (N) [At 72 hours]

    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.

  9. Maximal oxygen consumption (VO2max) during an effort test on a cycloergometer [At 72 hours]

  10. Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire [At inclusion]

    Score from 0 to 52

  11. Quality of life via the SF-36 questionnaire [At inclusion]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu de Saint-Etienne Saint-Étienne France 42055

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT05413590
Other Study ID Numbers:
  • 21CH033
  • ANSM
First Posted:
Jun 10, 2022
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2022