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Exercise-snacks at Work: Impact on Cardiometabolic Parameters

Primary Purpose

Sedentary Time, Overweight and Obesity, Work-Related Condition

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Exercise-snacks program
Sponsored by
University of Avignon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sedentary Time focused on measuring brief intense exercise, vascular function, cardiorespiratory fitness

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Avignon UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise-snacks group

Control group

Arm Description

They will perform a "exercise-snacks" program and receive information about physical activity

They will maintain their usual lifestyle until the end of the study

Outcomes

Primary Outcome Measures

Changes in aerobic fitness
Aerobic fitness will be assessed via the Chester step test's prediction of VO2max

Secondary Outcome Measures

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
Intensity of exercise-snacks
Heart rate during exercise-snacks in % heart rate max
Changes in flow mediated dilation of superficial femoral artery
measured by echocardiography (Vivid Q, GE) , in %
Changes in peak shear rate of superficial femoral artery
measured by echocardiography (Vivid Q, GE) during hyperemia, in s-1
Changes in nitrate mediated dilation of superficial femoral artery
by echocardiography (Vivid Q, GE), in %
Changes in superficial femoral artery compliance
by echocardiography (Vivid Q, GE), in mm2 mmHg-1
Changes in carotid intima-thickness
by echocardiography (Vivid Q) in mm
Changes in carotid compliance
by echocardiography (Vivid Q) in mm2 mmHg-1
Changes in carotid-femoral pulse wave velocity
by Sphygmocor, in m.s-1
Changes in post-occlusive skin perfusion
by Laser Doppler (Perimed), in perfusion unit, in area under the curve, in time to peak
Changes in blood pressure
systolic, diastolic, mean and pulsed
Changes in mean amplitude of glycemic excursions
measured by continuous glucose monitoring (FreeStyle), in mmol.L-1
Changes in heart rate
Heart rate at rest, at the end of the Chester step test and during exercise
Changes in level of habitual physical activity
Physical Activity questionnaire
Changes in fat mass
measured by InBody, in kg
Changes in lean mass
measured by InBody, in kg
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.
Changes in rating of perceived exertion
measured during the Chester test, score range from 7 to 20 with higher scores mean a worse outcome.

Full Information

First Posted
June 19, 2023
Last Updated
July 4, 2023
Sponsor
University of Avignon
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1. Study Identification

Unique Protocol Identification Number
NCT05942144
Brief Title
Exercise-snacks at Work: Impact on Cardiometabolic Parameters
Official Title
Exercise-snacks: an Effective Strategy to Break Sitting Time and Improve Cardiometbaolic Health in Sedentary Overweight Office Workers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
July 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Avignon

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Time, Overweight and Obesity, Work-Related Condition
Keywords
brief intense exercise, vascular function, cardiorespiratory fitness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise-snacks group
Arm Type
Experimental
Arm Description
They will perform a "exercise-snacks" program and receive information about physical activity
Arm Title
Control group
Arm Type
No Intervention
Arm Description
They will maintain their usual lifestyle until the end of the study
Intervention Type
Other
Intervention Name(s)
Exercise-snacks program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in aerobic fitness
Description
Aerobic fitness will be assessed via the Chester step test's prediction of VO2max
Time Frame
at inclusion, at the end of the 4-weeks program and 1 month following the end of the program
Secondary Outcome Measure Information:
Title
Adherence of staff in the experimental group by analyzing accelerometric data.
Description
Total number of exercise-snacks performed during the 4-week program by analysing accelerometers data
Time Frame
during the 4-weeks program
Title
Intensity of exercise-snacks
Description
Heart rate during exercise-snacks in % heart rate max
Time Frame
during the 4-weeks program
Title
Changes in flow mediated dilation of superficial femoral artery
Description
measured by echocardiography (Vivid Q, GE) , in %
Time Frame
at inclusion, at the end of the 4-weeks program
Title
Changes in peak shear rate of superficial femoral artery
Description
measured by echocardiography (Vivid Q, GE) during hyperemia, in s-1
Time Frame
at inclusion, at the end of the 4-weeks program
Title
Changes in nitrate mediated dilation of superficial femoral artery
Description
by echocardiography (Vivid Q, GE), in %
Time Frame
at inclusion, at the end of the 4-weeks program
Title
Changes in superficial femoral artery compliance
Description
by echocardiography (Vivid Q, GE), in mm2 mmHg-1
Time Frame
at inclusion, at the end of the 4-weeks program
Title
Changes in carotid intima-thickness
Description
by echocardiography (Vivid Q) in mm
Time Frame
at inclusion, at the end of the 4-weeks program
Title
Changes in carotid compliance
Description
by echocardiography (Vivid Q) in mm2 mmHg-1
Time Frame
at inclusion, at the end of the 4-weeks program
Title
Changes in carotid-femoral pulse wave velocity
Description
by Sphygmocor, in m.s-1
Time Frame
at inclusion, at the end of the 4-weeks program
Title
Changes in post-occlusive skin perfusion
Description
by Laser Doppler (Perimed), in perfusion unit, in area under the curve, in time to peak
Time Frame
at inclusion, at the end of the 4-weeks program
Title
Changes in blood pressure
Description
systolic, diastolic, mean and pulsed
Time Frame
at inclusion, at the end of the 4-weeks program and 1 month following the end of the program
Title
Changes in mean amplitude of glycemic excursions
Description
measured by continuous glucose monitoring (FreeStyle), in mmol.L-1
Time Frame
one week before the beginning of the program and the first week of the program and the 2 lastest weeks of the program
Title
Changes in heart rate
Description
Heart rate at rest, at the end of the Chester step test and during exercise
Time Frame
between the beginning and end of the 4-week exercise program and 4 weeks after the program.
Title
Changes in level of habitual physical activity
Description
Physical Activity questionnaire
Time Frame
between the start and end of the 4-week exercise program and 4 weeks after the program
Title
Changes in fat mass
Description
measured by InBody, in kg
Time Frame
between the start and end of the 4-week exercise program and 4 weeks after the program
Title
Changes in lean mass
Description
measured by InBody, in kg
Time Frame
between the start and end of the 4-week exercise program and 4 weeks after the program
Title
Change in physical activity behaviour at work of staff
Description
Theory of planned behavior questionnaire, score range from 20 to 80 with higher scores mean a better outcome.
Time Frame
between the start and end of the 4-week exercise program.
Title
Changes in rating of perceived exertion
Description
measured during the Chester test, score range from 7 to 20 with higher scores mean a worse outcome.
Time Frame
between the start and end of the 4-week exercise program and 4 weeks after the program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnès VINET
Phone
+33413951344
Email
agnes.vinet@univ-avignon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnès VINET
Organizational Affiliation
Avignon University - LaPEC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avignon University
City
Avignon
ZIP/Postal Code
84000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnès VINET
Phone
+33413951344
Email
agnes.vinet@univ-avignon.fr

12. IPD Sharing Statement

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Exercise-snacks at Work: Impact on Cardiometabolic Parameters

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