- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02263573
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Strasbourg Cedex, Frankrike, 67091
- Hôpitaux Universitaires de Strasbourg
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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).
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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. |
Aktiv komparator: Control group
Subjects do not participate in the program PEP'C-R and continue their usual activities at home for 9.5 weeks.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in intensity in W of the first ventilatory threshold (VT1)
Tidsram: From baseline to 9.5 weeks
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Determine the intensity in W of the first ventilatory threshold (VT1) for the experimental group and for the control group.
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From baseline to 9.5 weeks
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Thomas VOGEL, MD, PhD, CHRU Strasbourg
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 5830
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