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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05942144
Other study ID # AU-062023-AVJ
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 16, 2023
Est. completion date July 20, 2024

Study information

Verified date July 2023
Source University of Avignon
Contact Agnès VINET
Phone +33413951344
Email agnes.vinet@univ-avignon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective is to measure the effects of intense brief exercise program in the workplace of administrative staff on the cardio-metabolic health


Description:

Backgrounds: Very short (< 1 minute) and intense exercises, entitled "exercise-snacks", have been reported to be effective 1) in improving physical fitness over 6 weeks and 2) in improving vascular function and lowering blood glucose levels over one day. These studies were all carried out in the laboratory. The question therefore arises as to whether these acute vascular and metabolic benefits, as well as those on physical fitness, are sustainable over time following a chronic "exercise-snacks" program applicable in the professional environment to sedentary, overweight people. Aims of this project is therefore to measure the effects of an "exercise-snacks" type physical activity program in the workplace of administrative staff on the cardio-metabolic health and sedentary behaviour of staff.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date July 20, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria: - administrative staff, - age between 30 and 60, - body mass index =25kg/m², - sedentary time =7h/day, - minimum 3 working days on site, - no known cardiovascular or metabolic pathology, social security affiliation or benefit, - ability and willingness to give free, written and informed consent. Exclusion Criteria: - pregnant or breast-feeding women, - anti-hypertensive treatment, beta-blockers and anti-diabetics, - known contraindications to physical activity (articular, cardiac or other), - exercise-induced asthma, - lack of motivation of subjects posing problems of compliance and adherence to the exercise program, - participation in a study in the preceding 3 months, ongoing participation in a clinical trial.

Study Design


Intervention

Other:
Exercise-snacks program
Subjects in the exercise-snacks group will perform 4 "exercise-snacks" sessions per working day for 4 weeks. These sessions will consist of 80 one-to-one walks to be completed as quickly as possible. They will also receive information about their attitudes to physical activity.

Locations

Country Name City State
France Avignon University Avignon

Sponsors (1)

Lead Sponsor Collaborator
University of Avignon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in aerobic fitness Aerobic fitness will be assessed via the Chester step test's prediction of VO2max at inclusion, at the end of the 4-weeks program and 1 month following the end of the program
Secondary Adherence of staff in the experimental group by analyzing accelerometric data. Total number of exercise-snacks performed during the 4-week program by analysing accelerometers data during the 4-weeks program
Secondary Intensity of exercise-snacks Heart rate during exercise-snacks in % heart rate max during the 4-weeks program
Secondary Changes in flow mediated dilation of superficial femoral artery measured by echocardiography (Vivid Q, GE) , in % at inclusion, at the end of the 4-weeks program
Secondary Changes in peak shear rate of superficial femoral artery measured by echocardiography (Vivid Q, GE) during hyperemia, in s-1 at inclusion, at the end of the 4-weeks program
Secondary Changes in nitrate mediated dilation of superficial femoral artery by echocardiography (Vivid Q, GE), in % at inclusion, at the end of the 4-weeks program
Secondary Changes in superficial femoral artery compliance by echocardiography (Vivid Q, GE), in mm2 mmHg-1 at inclusion, at the end of the 4-weeks program
Secondary Changes in carotid intima-thickness by echocardiography (Vivid Q) in mm at inclusion, at the end of the 4-weeks program
Secondary Changes in carotid compliance by echocardiography (Vivid Q) in mm2 mmHg-1 at inclusion, at the end of the 4-weeks program
Secondary Changes in carotid-femoral pulse wave velocity by Sphygmocor, in m.s-1 at inclusion, at the end of the 4-weeks program
Secondary Changes in post-occlusive skin perfusion by Laser Doppler (Perimed), in perfusion unit, in area under the curve, in time to peak at inclusion, at the end of the 4-weeks program
Secondary Changes in blood pressure systolic, diastolic, mean and pulsed at inclusion, at the end of the 4-weeks program and 1 month following the end of the program
Secondary Changes in mean amplitude of glycemic excursions measured by continuous glucose monitoring (FreeStyle), in mmol.L-1 one week before the beginning of the program and the first week of the program and the 2 lastest weeks of the program
Secondary Changes in heart rate Heart rate at rest, at the end of the Chester step test and during exercise between the beginning and end of the 4-week exercise program and 4 weeks after the program.
Secondary Changes in level of habitual physical activity Physical Activity questionnaire between the start and end of the 4-week exercise program and 4 weeks after the program
Secondary Changes in fat mass measured by InBody, in kg between the start and end of the 4-week exercise program and 4 weeks after the program
Secondary Changes in lean mass measured by InBody, in kg between the start and end of the 4-week exercise program and 4 weeks after the program
Secondary Change in physical activity behaviour at work of staff Theory of planned behavior questionnaire, score range from 20 to 80 with higher scores mean a better outcome. between the start and end of the 4-week exercise program.
Secondary Changes in rating of perceived exertion measured during the Chester test, score range from 7 to 20 with higher scores mean a worse outcome. between the start and end of the 4-week exercise program and 4 weeks after the program
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