Cardio-Respiratory FailureEVOP-53NCT05082324
Evaluation of Modification in VO2 Max After Performing the "Physical Activity and Health Course (PAPS) 53" Program
A study testing Adapted physical activity in people with Cardio-Respiratory Failure, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardio-Respiratory Failure
- What is being tested?
- Adapted physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2022to 4 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Adapted physical activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted physical activityOther
Patient participates in an adapted physical activity program for 3 months, with 2 one-hour sports sessions per week
| Study group | Role | What they receive |
|---|---|---|
| adapted physical activity | Experimental | Not described Receives: Other: Adapted physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess maximal oxygen consumption (VO2 max) measured during an effort test
Effort test
Measured: 3 month
Secondary outcomes (1)
To assess the quality of life
Short Form-36; min value 36 and max value 149
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start4 Jan 2022 (estimated)
- Primary completion4 May 2022 (estimated)
- Study completion4 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardio-Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082324
- Sponsor's protocol ID
- 49RC21_0332
- Acronym
- EVOP-53
- Status last verified
- Oct 2021
- First submitted
- 1 Oct 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Modification in VO2 Max After Performing the PAPS 53 Program
- ClinicalTrials.gov ID
- NCT05082324
- Acronym / sponsor ID
- EVOP-53 / 49RC21_0332
- Conditions
- Cardio-Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 4 Jan 2022 (estimated)
- Primary completion
- 4 May 2022 (estimated)
- Study completion
- 4 May 2022 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adapted physical activity | Experimental | Other: Adapted physical activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted physical activityPatient participates in an adapted physical activity program for 3 months, with 2 one-hour sports sessions per week | Other | adapted physical activity |
Primary outcome
To assess maximal oxygen consumption (VO2 max) measured during an effort test
Time frame: 3 month
Effort test
1 secondary outcome
To assess the quality of life
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted physical activity in people with Cardio-Respiratory Failure, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DRCI Promotion Interne (0241353637 ext. +33, DRCI-Promotion-Interne@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess maximal oxygen consumption (VO2 max) measured during an effort test (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.