Sedentary Lifestyle in Patients Over 70PEP'C-RNCT02263573
Effect of PEP'C-R on Endurance Parameters and Maximal Cardio-respiratory Function Among Sedentary Older Seniors Over 70
A study testing PEP'C-R in people with Sedentary Lifestyle in Patients Over 70, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle in Patients Over 70
- What is being tested?
- PEP'C-R
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2014to 18 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Subject treated with beta-blockers and other negative chronotropic molecules.
- Acute infection at the time of inclusion.
- Dependent patient.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Sedentary Lifestyle in Patients Over 70
- Being tested
- PEP'C-R, Control group usual activities
- Keywords
- PEP'C-R, Endurance parameters, Maximal cardio-respiratory function, Older seniors, Over 70
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP'C-ROther
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 activitiesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PEP'C-R | Experimental | Subjects will benefit from one preliminary session and 18 sessions of PEP'C-R, (2 sessions per week for 9.5 weeks). Receives: Other: PEP'C-R |
| Control group | Active comparator | Subjects do not participate in the program PEP'C-R and continue their usual activities at home for 9.5 weeks. Receives: Other: Control group usual activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 9.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study start4 Dec 2014
- Primary completion18 Oct 2017
- Study completion18 Oct 2017
Why it stopped: * Interim analysis on 60 randomized subjects showed significant result for the main outcome (VT1) * Enrollment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary Lifestyle in Patients Over 70Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas VOGEL, MD, PhD, Principal investigator, CHRU Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263573
- Sponsor's protocol ID
- 5830
- Acronym
- PEP'C-R
- Status last verified
- May 2018
- First submitted
- 1 Oct 2014
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29963733
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02263573
- Acronym / sponsor ID
- PEP'C-R / 5830
- Conditions
- Sedentary Lifestyle in Patients Over 70
- Keywords
- PEP'C-R, Endurance parameters, Maximal cardio-respiratory function, Older seniors, Over 70
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: * Interim analysis on 60 randomized subjects showed significant result for the main outcome (VT1) * Enrollment difficulty
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Dec 2014 (actual)
- Primary completion
- 18 Oct 2017 (actual)
- Study completion
- 18 Oct 2017 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEP'C-R | Experimental | Other: PEP'C-RSubjects will benefit from one preliminary session and 18 sessions of PEP'C-R, (2 sessions per week for 9.5 weeks). |
| Control group | Active comparator | Other: Control group usual activitiesSubjects do not participate in the program PEP'C-R and continue their usual activities at home for 9.5 weeks. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEP'C-RPreliminary 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. | Other | PEP'C-R |
| Control group usual activitiesParticipants 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. | Other | Control group |
Primary outcome
Change in intensity in W of the first ventilatory threshold (VT1)
Time frame: 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.
Results and safety
The study was stopped early (reason given: * Interim analysis on 60 randomized subjects showed significant result for the main outcome (VT1) * Enrollment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Derived from this study: PubMed 29963733Bouaziz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas VOGEL, MD, PhD principal investigator
CHRU Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEP'C-R in people with Sedentary Lifestyle in Patients Over 70, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: * Interim analysis on 60 randomized subjects showed significant result for the main outcome (VT1) * Enrollment difficulty). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intensity in W of the first ventilatory threshold (VT1) (time frame: From baseline to 9.5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02263573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.