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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-04

Study Completion Date

2017-10-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Sedentary Lifestyle in Patients Over 70

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

PEP'C-R

Intervention Type OTHER

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

Subjects do not participate in the program PEP'C-R and continue their usual activities at home for 9.5 weeks.

Group Type ACTIVE_COMPARATOR

Control group usual activities

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes