Physical InactivityNCT05146544
Characteristic and Real Intensity of Exercise in a Hospital-based Physical Activity Protocol for Patients With Chronic Disease
An observational study of Physical Inactivity, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The objective is to better characterize an adapted physical activity (APA) program within of the management of chronic diseases. In France, since 2016, medical doctors have been able to prescribe APA to their patients with chronic diseases but while there are indeed prescription recommendations, there is no clear… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Heart Rate Recording
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Observational
- 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
Study population: This is a cross-sectional monocentric study performed at the Nancy University Center of Sports Medicine and APA, France, between February 2020 and July 2021, in patients requiring implementation of APA.
Who may be able to join
- age greater than 18 years old, with the ability to perform a cardiopulmonary exercise test
Who cannot join
- beta-blocker treatment.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Régional Universitaire de Nancy.
Vandœuvre-lès-Nancy, 54500
About this study
The objective is to better characterize an adapted physical activity (APA) program within of the management of chronic diseases.
In France, since 2016, medical doctors have been able to prescribe APA to their patients with chronic diseases but while there are indeed prescription recommendations, there is no clear characterization of the practical reality of APA programs.
Read more
The interest of this work is to benefit from the experience of the Center of Sports Medicine and Adapted Physical Activities in Nancy (France) specifically dedicated to the prescription and the initiation of an APA program for of patients with a chronic disease.
Thus, this work aims to determine the real intensity of the APA, the effectiveness of the assessment necessary for the dispensation of the APA and other parameters likely to modify the result of the treatment.
- Conditions
- Physical Inactivity
- Being tested
- Heart Rate Recording
- Keywords
- Adapted Physical activity, Chronic disease, exercise
- Medical subject headings
- Sedentary Behavior, Chronic Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Rate RecordingOther
During the APA session, HR was digitized at 1Hz (using custo guard, Custo Med GmbH). The ratio between the APA session HR and exercise test HRpeak was used to assess the intensity of effort.
| Study group | Role | What they receive |
|---|---|---|
| No limitation of exercise performance capacities | normal maximal oxygen uptake (greater than or equal to 80% of the reference value) Receives: Other: Heart Rate Recording | |
| Limitation of exercise performance capacities | reduced maximal oxygen uptake (less than 80% of the reference value). Receives: Other: Heart Rate Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the real intensity level of adapted physical activity (APA).
evaluate the real intensity level of exercise in a sample of patients with chronic disease involved in a hospital-based program of adapted physical activity (APA).
Measured: Heart rate mean during 1 hour in the first APA Session (cross-sectional monocentric study)
Secondary outcomes (2)
Evaluate Six-Minute Walk Test (6-MWT) efficacity to determine physical activity capacities
evaluate Six-Minute Walk Test (6-MWT) efficacity to determine physical activity capacities for patients with chronic disease.
Measured: 6 minutes in the first APA Session (cross-sectional monocentric study)
Evaluate sit-to-stand test (1 minute)) efficacity to determine physical activity capacities
Evaluate sit-to-stand test (1 minute)) efficacity to determine physical activity capacitiesfor patients with chronic disease.
Measured: 1 minute in the first APA Session (cross-sectional monocentric study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edem ALLADO, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146544
- Sponsor's protocol ID
- 2021-PI191
- Status last verified
- Feb 2023
- First submitted
- 9 Nov 2021
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristic and Real Intensity of Exercise in a Hospital-based Physical Activity Protocol for Patients With Chronic Disease
- ClinicalTrials.gov ID
- NCT05146544
- Acronym / sponsor ID
- 2021-PI191
- Conditions
- Physical Inactivity
- Keywords
- Adapted Physical activity, Chronic disease, exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 Dec 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.
The objective is to better characterize an adapted physical activity (APA) program within of the management of chronic diseases.
In France, since 2016, medical doctors have been able to prescribe APA to their patients with chronic diseases but while there are indeed prescription recommendations, there is no clear characterization of the practical reality of APA programs.
The interest of this work is to benefit from the experience of the Center of Sports Medicine and Adapted Physical Activities in Nancy (France) specifically dedicated to the prescription and the initiation of an APA program for of patients with a chronic disease.
Thus, this work aims to determine the real intensity of the APA, the effectiveness of the assessment necessary for the dispensation of the APA and other parameters likely to modify the result of the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No limitation of exercise performance capacities | – | Other: Heart Rate Recordingnormal maximal oxygen uptake (greater than or equal to 80% of the reference value) |
| Limitation of exercise performance capacities | – | Other: Heart Rate Recordingreduced maximal oxygen uptake (less than 80% of the reference value). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a cross-sectional monocentric study performed at the Nancy University Center of Sports Medicine and APA, France, between February 2020 and July 2021, in patients requiring implementation of APA.
Key inclusion criteria (1 listed)
- age greater than 18 years old, with the ability to perform a cardiopulmonary exercise test
Key exclusion criteria (1 listed)
- beta-blocker treatment.
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 |
|---|---|---|
| Heart Rate RecordingDuring the APA session, HR was digitized at 1Hz (using custo guard, Custo Med GmbH). The ratio between the APA session HR and exercise test HRpeak was used to assess the intensity of effort. | Other | Limitation of exercise performance capacities, No limitation of exercise performance capacities |
Primary outcome
evaluate the real intensity level of adapted physical activity (APA).
Time frame: Heart rate mean during 1 hour in the first APA Session (cross-sectional monocentric study)
evaluate the real intensity level of exercise in a sample of patients with chronic disease involved in a hospital-based program of adapted physical activity (APA).
2 secondary outcomes
Evaluate Six-Minute Walk Test (6-MWT) efficacity to determine physical activity capacities
Time frame: 6 minutes in the first APA Session (cross-sectional monocentric study)
Evaluate sit-to-stand test (1 minute)) efficacity to determine physical activity capacities
Time frame: 1 minute in the first APA Session (cross-sectional monocentric study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Inactivity, run by Central Hospital, Nancy, France 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the real intensity level of adapted physical activity (APA). (time frame: Heart rate mean during 1 hour in the first APA Session (cross-sectional monocentric study)). 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 27 Feb 2023.