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

NCT05082324 | Unknown

• 1 other identifier: 49RC21_0332
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Cardio-Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• To assess maximal oxygen consumption (VO2 max) measured during an effort test

  Effort test

  3 month

Secondary Outcomes (1)

• To assess the quality of life

  3 month

Study Arms (1)

adapted physical activity

EXPERIMENTAL

Other: Adapted physical activity

Interventions

Adapted physical activity OTHER

Patient participates in an adapted physical activity program for 3 months, with 2 one-hour sports sessions per week

adapted physical activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CH Laval

Laval, France

Location

Central Study Contacts

DRCI Promotion Interne

CONTACT

0241353637; DRCI-Promotion-Interne@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 18, 2021
• Study Start: January 4, 2022
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2022
• Last Updated: October 20, 2021

Record last verified: 2021-10

Locations

FR (1)