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

Sedentary Lifestyle in Patients Over 70 Clinical Trial

— PEP'C-R  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02263573
• Other study ID #: 5830
• Status: Terminated
• Phase: N/A
• Start date: December 4, 2014
• Est. completion date: October 18, 2017

Study information

• Verified date: May 2018
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: October 18, 2017
• Est. primary completion date: October 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sedentary Lifestyle in Patients Over 70

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	Strasbourg Cedex

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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