Evaluation of Modification in VO2 Max After Performing the "Physical Activity and Health Course (PAPS) 53" Program (EVOP-53)

Evaluation of Modification in VO2 Max After Performing the PAPS 53 Program

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cardio-Respiratory Failure
• Intervention / Treatment: Other: Adapted physical activity

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Laval, France
    • CH Laval
    • Contact: GODET Raphaël; Email: raphael.godet@chlaval.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: adapted physical activity	Other: Adapted physical activity; Patient participates in an adapted physical activity program for 3 months, with 2 one-hour sports sessions per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess maximal oxygen consumption (VO2 max) measured during an effort test	Effort test	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the quality of life	Short Form-36; min value 36 and max value 149	3 month

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Anticipated): January 4, 2022
• Primary Completion (Anticipated): May 4, 2022
• Study Completion (Anticipated): May 4, 2022

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 49RC21_0332

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No