- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05740241
Use of New Tools to Estimate the Intensity of Adapted Physical Activity Sessions (UNITS-APA)
In the field of sport/health, the prescription is generic and individualisation, which is still very rare, is generally linked only to physical performance. These limitations on the implementation of the sessions will result in limiting the effects of the training programme and increasing the risk of injury. It is therefore necessary to develop knowledge and tools to assist physicians and physical activity professionals in their decision making.
The aim of the study is to improve the precision of the calculation of the training load in order to better individualise the management of the participants.
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Olivier GUERIN
- Phone Number: +33 4 92 03 41 94
- Email: guerin.o@chu-nice.fr
Study Locations
-
-
-
Nice, France, 06000
- Recruiting
- GUERIN
-
Principal Investigator:
- Olivier GUERIN, Pr
-
Contact:
- Olivier GUERIN, Pr
- Phone Number: +33 4 92 03 41 94
- Email: guerin.o@chu-nice.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Person having signed the non-opposition
- Person affiliated to the social security system.
- Male or female adult over 65 years of age.
Exclusion Criteria:
- Person under protective measures (guardianship, curators, private, under court protection).
- Person suffering from a neurological problem affecting mobility (MMSE test < 24).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy participants aged more than 65 years old
Participation in 8 physical activity sessions, lasting 45 minutes, at the rate of 2 sessions per week
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A group of participants with physical activity (protocolized)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Training Load
Time Frame: Measured at day 0
|
The training load measured after each physical activity session measured with the different methods.
The training load will be estimate with: the number of sets x the number of repetitions x the intensity of the exercise.
The measure of the intensity of the exercises will be compute from vector magnitude from actimetry and motion capture.
For the control method, the intensity of the exercise will be estimate by adapted physical activity engineers.
|
Measured at day 0
|
Training Load
Time Frame: Measured at day 3
|
The training load measured after each physical activity session measured with the different methods.
The training load will be estimate with: the number of sets x the number of repetitions x the intensity of the exercise.
The measure of the intensity of the exercises will be compute from vector magnitude from actimetry and motion capture.
For the control method, the intensity of the exercise will be estimate by adapted physical activity engineers.
|
Measured at day 3
|
Training Load
Time Frame: Measured at day 7
|
The training load measured after each physical activity session measured with the different methods.
The training load will be estimate with: the number of sets x the number of repetitions x the intensity of the exercise.
The measure of the intensity of the exercises will be compute from vector magnitude from actimetry and motion capture.
For the control method, the intensity of the exercise will be estimate by adapted physical activity engineers.
|
Measured at day 7
|
Training Load
Time Frame: Measured at day 10
|
The training load measured after each physical activity session measured with the different methods.
The training load will be estimate with: the number of sets x the number of repetitions x the intensity of the exercise.
The measure of the intensity of the exercises will be compute from vector magnitude from actimetry and motion capture.
For the control method, the intensity of the exercise will be estimate by adapted physical activity engineers.
|
Measured at day 10
|
Training Load
Time Frame: Measured at day 14.
|
The training load measured after each physical activity session measured with the different methods.
The training load will be estimate with: the number of sets x the number of repetitions x the intensity of the exercise.
The measure of the intensity of the exercises will be compute from vector magnitude from actimetry and motion capture.
For the control method, the intensity of the exercise will be estimate by adapted physical activity engineers.
|
Measured at day 14.
|
Training Load
Time Frame: Measured at day 17
|
The training load measured after each physical activity session measured with the different methods.
The training load will be estimate with: the number of sets x the number of repetitions x the intensity of the exercise.
The measure of the intensity of the exercises will be compute from vector magnitude from actimetry and motion capture.
For the control method, the intensity of the exercise will be estimate by adapted physical activity engineers.
|
Measured at day 17
|
Training Load
Time Frame: Measured at day 21
|
The training load measured after each physical activity session measured with the different methods.
The training load will be estimate with: the number of sets x the number of repetitions x the intensity of the exercise.
The measure of the intensity of the exercises will be compute from vector magnitude from actimetry and motion capture.
For the control method, the intensity of the exercise will be estimate by adapted physical activity engineers.
|
Measured at day 21
|
Training Load
Time Frame: Measured at day 24.
|
The training load measured after each physical activity session measured with the different methods.
The training load will be estimate with: the number of sets x the number of repetitions x the intensity of the exercise.
The measure of the intensity of the exercises will be compute from vector magnitude from actimetry and motion capture.
For the control method, the intensity of the exercise will be estimate by adapted physical activity engineers.
|
Measured at day 24.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercises Intensity
Time Frame: Measured at day 0, day 3, day 7, day 10, day 14, day 17, day 21, day 24.
|
Assessment of exercises intensity will be quantify by the Rate Perceived Exertion (RPE).
The RPE scale ranges from 0 to 10.
The number indicates how easy or difficult the participant finds an activity.
For example, 2-3 is a light activity and 10 is a maximal effort activity.
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Measured at day 0, day 3, day 7, day 10, day 14, day 17, day 21, day 24.
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Exercises classification
Time Frame: Measured at day 0, day 3, day 7, day 10, day 14, day 17, day 21, day 24.
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To evaluate the prediction of the exercises, we will analyse the accuracy of the measurement with a confusion matrix on the prediction of the movements that decompose the different exercises. This matrix will allow us to determine the accuracy of the classifier according to the rate of false positives and the rate of false negatives. accuracy = (TP + TN) / (TP + TN + FP + FN) Where TP = number of True Positives, TN = number of True negatives, FP = number of False Positives, and FN = number of False Negatives. |
Measured at day 0, day 3, day 7, day 10, day 14, day 17, day 21, day 24.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Olivier GUERIN, University Hospital of Nice
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22-AOI-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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