Effect of PEP'C-R on Endurance Parameters and Maximal Cardio-respiratory Function Among Sedentary Older Seniors Over 70

Not Applicable

Terminated

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

• Registration Number: NCT02263573
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-01
• Study First Submitted QC: 2014-10-10
• Study First Posted: 2014-10-13
• Study Start: 2014-12-04
• Primary Completion: 2017-10-18
• Study Completion: 2017-10-18
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-22
• Last Update Posted: 2018-05-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEP'C-R	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).
Control group	Control group usual activities	Subjects do not participate in the program PEP'C-R and continue their usual activities at home for 9.5 weeks.

Primary Outcome Measures

Name	Time	Method
Change in intensity in W of the first ventilatory threshold (VT1)	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.

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg Cedex, France