NCT05413590

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.5 years

First QC Date

February 10, 2022

Last Update Submit

September 10, 2024

Conditions

Keywords

cardiovascular functionneuromuscular functionV02max

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Voluntary activation measurement (%)

    At 48 hours

  • Maximal voluntary contraction (MVC) of the plantar flexor muscle measurement

    At 48 hours

  • Maximal voluntary contraction (MVC) of the hand grip measurement

    At 48 hours

  • Cardiac variability(ms)

    At 48 hours

  • Muscle oxygenation (%)

    At 48 hours

  • +6 more secondary outcomes

Study Arms (6)

Young, Active group

ACTIVE COMPARATOR

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 completionOther: Isometric forcesOther: Energy cost

Young, sedentary group

ACTIVE COMPARATOR

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 completionOther: Isometric forcesOther: Energy cost

Old, Active group

ACTIVE COMPARATOR

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 completionOther: Isometric forcesOther: Energy cost

Old sedentary group

ACTIVE COMPARATOR

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 completionOther: Isometric forcesOther: Energy cost

Very old, Active group

ACTIVE COMPARATOR

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 completionOther: Isometric forcesOther: Energy cost

Very old sedentary group

ACTIVE COMPARATOR

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 completionOther: Isometric forcesOther: Energy cost

Interventions

Cognitive tests, completing questionnaires, balance test, measuring cardiac variability and post-ischemic hyperemia. Assessments of neuromuscular function on a semi-recumbent ergometric bicycle.

Old sedentary groupOld, Active groupVery old sedentary groupVery old, Active groupYoung, Active groupYoung, sedentary group

Measurement of the maximum isometric forces of the knee flexors, the plantar flexors of the ankle and the grip strength of the hand.

Old sedentary groupOld, Active groupVery old sedentary groupVery old, Active groupYoung, Active groupYoung, sedentary group

Measurement of feet pressure and measurement of the energy cost. Maximum test on an endocycle (classic) to determine VO2max.

Old sedentary groupOld, Active groupVery old sedentary groupVery old, Active groupYoung, Active groupYoung, sedentary group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Saint-Etienne

Saint-Etienne, 42055, France

Location

Related Publications (1)

  • Luneau E, Rozand V, Murias JM, Millet GY. Effect of Habitual Physical Activity on Strength Loss and Fatigability in Old and Very Old Men. Scand J Med Sci Sports. 2025 Dec;35(12):e70176. doi: 10.1111/sms.70176.

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • LEONARD FEASSON, PHD

    Centre Hospitalier Universitaire de Saint Etienne

    PRINCIPAL INVESTIGATOR
  • Guillaume MILLET, PhD

    UNIVERSITE DE SAINT ETIENNE

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2022

First Posted

June 10, 2022

Study Start

November 30, 2021

Primary Completion

May 23, 2023

Study Completion

June 6, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations