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

Sponsor

University Hospital, Angers (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05082324

Collaborator

(none)

Enrollment

Location

Arm

3.9

Anticipated Duration (Months)

15.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Cardio-Respiratory Failure	Other: Adapted physical activity	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 4, 2022

Anticipated Primary Completion Date :

May 4, 2022

Anticipated Study Completion Date :

May 4, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

To assess maximal oxygen consumption (VO2 max) measured during an effort test [3 month]
Effort test

Secondary Outcome Measures

To assess the quality of life [3 month]
Short Form-36; min value 36 and max value 149

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CH Laval	Laval		France

Sponsors and Collaborators

University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT05082324

Other Study ID Numbers:

49RC21_0332

First Posted:

Oct 18, 2021

Last Update Posted:

Oct 20, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Insufficiency

Study Results

No Results Posted as of Oct 20, 2021