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: Terminated
• Conditions: Sedentary Lifestyle in Patients Over 70
• Intervention / Treatment: Other: PEP'C-R; Other: Control group usual activities

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg Cedex, France, 67091
    • Hôpitaux universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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)

Number of Arms

2

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).	Other: PEP'C-R; 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.	Other: Control group usual activities; 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)	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

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Thomas VOGEL, MD, PhD, CHRU Strasbourg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2014
• Primary Completion (Actual): October 18, 2017
• Study Completion (Actual): October 18, 2017

Study Registration Dates

• First Submitted: October 1, 2014
• First Submitted That Met QC Criteria: October 10, 2014
• First Posted (Estimate): October 13, 2014

Study Record Updates

• Last Update Posted (Actual): May 24, 2018
• Last Update Submitted That Met QC Criteria: May 22, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: PEP'C-R; Endurance parameters; Maximal cardio-respiratory function; Older seniors; Over 70
• Other Study ID Numbers: 5830