Effect of PEP'C-R on Endurance Parameters and Maximal Cardio-respiratory Function Among Sedentary Older Seniors Over 70 (PEP'C-R)
Effect of a New Training Protocol: the PEP'C With Constant Load and Intermittent Recovery (PEP'C-R), on Endurance Parameters and Maximal Cardio-respiratory Function Among Sedentary Older Seniors Over 70.
The primary purpose of the protocol is to determine the effects of a new program of PEP'C "PEP'C with constant load and intermittent recovery" (PEP'C-R) on endurance parameters of older seniors.
The study hypothesis: the investigators propose that PEP'C-R training offers a significant improvement in endurance parameters for older seniors.
The secondary objectives are to determine the effects of PEP'C-R on maximal cardio-respiratory function, FMD (Flow-mediated dilation), PWV (pulse wave velocity), systolic and diastolic heart function, body composition (measured by impedance), biological, functional and cognitive functioning and quality of life.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Strasbourg Cedex, France, 67091
- Hôpitaux Universitaires de Strasbourg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Low physical activity determined using the questionnaire IPAQ in METs (<3).
- Informed about the results of examinations performed at screening visit.
- Subject able to understand the purpose, procedures and risks of the study and give written informed consent.
Exclusion Criteria:
- Contraindications to perform the cardiac stress test and PEP'C-R (Musculoskeletal limitations, Unstabilized heart Failure with chest pain on exertion under maximal medical therapy, ventricular and supraventricular disorders, Acute coronary syndrome within <1 month, Unstabilized respiratory failure or oxygen-dependent)
- Abnormality shown at the cardiac stress test : clinical abnormality (chest pain), electric abnormality (found on ECG), abnormal blood pressure, abnormality of the ventilatory system (bronchospasm, hypoxemia,...)
- Cognitive impairment which exclude PEP'C-R training.
- Current Cancer chemotherapy.
- Visual Impairment which exclude PEP'C-R training.
- Presence of fibromyalgia.
- Subject treated with beta-blockers and other negative chronotropic molecules.
- Acute infection at the time of inclusion.
- Dependent patient.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PEP'C-R
Subjects will benefit from one preliminary session and 18 sessions of PEP'C-R, (2 sessions per week for 9.5 weeks).
|
Preliminary session of calibration and tolerance: Test of Borg: determination of VT1 for 10 minutes, 3 min pedaling at 25 W and then 20 minutes pedaling on VT1 determined during the exercise test (ET) -10%. Session 1: 30 min of pedaling at constant load VT1 determined during exercise testing (EE) - 10%. Session 2 Session 17: increase in the burden of BASE (5 BASE * 5 min: 25 min) by 10% and decrease in relation to the load of the PIC (5 PIC * 1 min: 5 min) to get a cumulative charge of the same session. Changes in heart rate (HR) determine the evolution of sustained loads: a decrease of 10 bpm in heart rate leads to an increase by 10% in the intensity of the base (PIC load remains constant). Session 18 = Session 1. |
|
Active Comparator: Control group
Subjects do not participate in the program PEP'C-R and continue their usual activities at home for 9.5 weeks.
|
Participants in the control group will not follow the intervention PEP'C-R.
They will continue their usual activities for 9.5 weeks and will be assessed before and after this period.
After the study, they will be offered the benefit of the conventional program of the PEP'C.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in intensity in W of the first ventilatory threshold (VT1)
Time Frame: From baseline to 9.5 weeks
|
Determine the intensity in W of the first ventilatory threshold (VT1) for the experimental group and for the control group.
|
From baseline to 9.5 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Thomas VOGEL, MD, PhD, CHRU Strasbourg
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
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
- 5830
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.