Evaluation of Modification in VO2 Max After Performing the "Physical Activity and Health Course (PAPS) 53" Program (EVOP-53)
Primary Purpose
Cardio-Respiratory Failure
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adapted physical activity
Sponsored by
About this trial
This is an interventional prevention trial for Cardio-Respiratory Failure
Eligibility Criteria
Inclusion Criteria:
- Adult (≥ 18 years)
- Patient integrating the PAPS 53 with an indication to perform a stress test
- Person affiliated or benefiting from a social security plan
- Patient having signed an informed consent beforehand
Exclusion Criteria:
- Contraindication to the performance of the stress test
- Patient unable to understand the objectives or instructions of the study
- Poor understanding of the French language
- Pregnant, nursing or parturient woman
- Person deprived of liberty by judicial or administrative decision
- Person under forced psychiatric care
- Person admitted to a health or social institution for purposes other than research research
- Person subject to a legal protection measure
- Person unable to express his or her consent
- Person in a period of exclusion relative to another intervention research
Sites / Locations
- CH Laval
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
adapted physical activity
Arm Description
Outcomes
Primary Outcome Measures
To assess maximal oxygen consumption (VO2 max) measured during an effort test
Effort test
Secondary Outcome Measures
To assess the quality of life
Short Form-36; min value 36 and max value 149
Full Information
NCT ID
NCT05082324
First Posted
October 1, 2021
Last Updated
October 18, 2021
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT05082324
Brief Title
Evaluation of Modification in VO2 Max After Performing the "Physical Activity and Health Course (PAPS) 53" Program
Acronym
EVOP-53
Official Title
Evaluation of Modification in VO2 Max After Performing the PAPS 53 Program
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 4, 2022 (Anticipated)
Primary Completion Date
May 4, 2022 (Anticipated)
Study Completion Date
May 4, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Physical inactivity is the leading cause of preventable death in developed countries, ahead of smoking. It is responsible for 5.3 million (9%) of the 57 million deaths worldwide in 2008 and 10% of deaths in Europe.
Encouraging regular physical activity in the general population is a public health priority.
Cardiorespiratory capacity, measured during an exercise test, expressed as maximal oxygen consumption (VO2 max) or Metabolic Equivalent Task (MET) = oxygen consumption at rest [3.5 ml/kg/min], is an excellent indicator of individual exercise capacity and is increased by regular physical activity (PA).
Any gain in cardiorespiratory capacity of 1 MET is accompanied by a 12% reduction in mortality whether the subjects are free of any cardiovascular pathology or have a chronic pathology, regardless of their age.
As physical activity is an integral part of the management of many diseases, it seems essential to evaluate specific protocols oriented towards the maintenance or development of strength or endurance, or even mixed protocols.
The PAPS 53 (Physical Activity and Health Pathway), set up in Mayenne, responds to the demand for prescription of adapted physical activity. It is a 3-month program with 2 one-hour sports sessions per week (30 minutes of endurance and 30 minutes of muscle strengthening).
The National Sport and Health Strategy 2019-2024 expert group recommends better defining the characteristics of physical activity (intensity, frequency, etc.) to determine the effect (dose-response) on different at-risk populations and according to the type of pathology.
Investigators proposed to study by comparison the VO2 max values obtained during the two exercise tests (at inclusion and after 3 months of physical activity program). The hypothesis is that, after completion of the PAPS program, the VO2 max value of a patient will be significantly increased.
The control group is represented by the patients who have not yet followed the adapted physical activity program. The intervention group is therefore composed of the same patients. The aim is to compare the same group of eligible patients, before and after having followed the "PAPS 53" protocol
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardio-Respiratory Failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
adapted physical activity
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Adapted physical activity
Intervention Description
Patient participates in an adapted physical activity program for 3 months, with 2 one-hour sports sessions per week
Primary Outcome Measure Information:
Title
To assess maximal oxygen consumption (VO2 max) measured during an effort test
Description
Effort test
Time Frame
3 month
Secondary Outcome Measure Information:
Title
To assess the quality of life
Description
Short Form-36; min value 36 and max value 149
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (≥ 18 years)
Patient integrating the PAPS 53 with an indication to perform a stress test
Person affiliated or benefiting from a social security plan
Patient having signed an informed consent beforehand
Exclusion Criteria:
Contraindication to the performance of the stress test
Patient unable to understand the objectives or instructions of the study
Poor understanding of the French language
Pregnant, nursing or parturient woman
Person deprived of liberty by judicial or administrative decision
Person under forced psychiatric care
Person admitted to a health or social institution for purposes other than research research
Person subject to a legal protection measure
Person unable to express his or her consent
Person in a period of exclusion relative to another intervention research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DRCI Promotion Interne
Phone
0241353637
Ext
+33
Email
DRCI-Promotion-Interne@chu-angers.fr
Facility Information:
Facility Name
CH Laval
City
Laval
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GODET Raphaël
Email
raphael.godet@chlaval.fr
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Modification in VO2 Max After Performing the "Physical Activity and Health Course (PAPS) 53" Program
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