Clinical trial NCT02263573: Effect of PEP'C-R on Endurance Parameters and Maximal Cardio-respiratory Function Among Sedentary Older Seniors Over 70
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sedentary Lifestyle in Patients Over 70
Keywords: PEP'C-R
Endurance parameters
Maximal cardio-respiratory function
Older seniors
Over 70
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 62
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in intensity in W of the first ventilatory threshold (VT1)
timeFrame: From baseline to 9.5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg Cedex
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: CHRU Strasbourg
name: Thomas VOGEL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bouaziz W, Schmitt E, Vogel T, Lefebvre F, Lepretre PM, Kaltenbach G, Geny B, Lang PO. Effects of a short-term Interval Aerobic Training Programme with active Recovery bouts (IATP-R) on cognitive and mental health, functional performance and quality of life: A randomised controlled trial in sedentary seniors. Int J Clin Pract. 2019 Jan;73(1):e13219. doi: 10.1111/ijcp.13219. Epub 2018 Jul 2.