HealthyPRIOxNCT02594657
Pedal Rate Influence on Oxygen Consumption in Eccentric
A study testing pedal rate on 50 RPM and pedal rate on 80 RPM in people with Healthy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Nowadays, ECC exercise can be realized using various modalities that target small or large muscle masses in a segmentary or dynamic way. The training program proposed in this study is realised on an handmade ergocycle which allows eccentric contractions. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- pedal rate on 50 RPM and pedal rate on 80 RPM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2015to Oct 2016
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Males
- IMC <30
- physically active
- Pmax concentric > 200W
- Pmax > Pmax théo sédentaire
Who cannot join
- cardio pulmonary, osteo articulary or muscular diseases
- Eccentric based physical activities or sports (weight liftering, alpine skiing)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Ruddy RICHARD
About this study
Nowadays, ECC exercise can be realized using various modalities that target small or large muscle masses in a segmentary or dynamic way. The training program proposed in this study is realised on an handmade ergocycle which allows eccentric contractions.
With this type of ergometer, O2 consumption (VO2) is three to five fold lower than during an exercise realised at the same power output with a concentric ergocycle. Due to this later propertie, which origins are not yet fully identified, there is an increasing interest to embed ECC in rehabilitation programs.
Read more
The investigators hypothesis that a higher pedal rate will induce a lower oxygen consumption, with the same benefits.
This study aims to compare oxygen consumption at two pedal rates : 50 and 80 rotation per minute (rpm).
The ultimate goal is to assess efficacy and tolerance of eccentric training on ergocycle and to enhance comprehension of the physiological mecanisms involved in the lower O2 consumption observed.
Read the detailed description
The training program proposed in this study is realised on an handmade ergocycle which allows almost pur eccentric contractions.
Fifteen healthy volunteers realize a incremental test until exertion on a concentric ergometer. If the minimal power output of 200W is reached, the volunteers are familiarized with eccentric exercise during several bouts of exercise. This habituation session allows avoiding the secondary muscular effects of high intensity eccentric exercise.
Then, volunteers could take part in a two-stepped eccentric protocol: 1) an incremental test consisting in 3 stages. Each stage lasts 4 minutes.
- A constant-load test realized at 320W during 6 minutes. Each test is realized twice: at 50 and 80 rpm and sequence is randomly assigned.
[One step (incremental or constant load) = two tests (50 and 80 rpm)]
During each step, oxygen consumption is continuously measured, as well as cardiac output and muscular activity and intramuscular oxygen kinetic.
- Conditions
- Healthy
- Being tested
- pedal rate on 50 RPM, pedal rate on 80 RPM
- Keywords
- Eccentric, Ergometer, Pedal rate, Oxygen consumption, Only health volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pedal rate on 50 RPMProcedure or surgery
All measurements are performed in two pedalling situations. The two frequencies used will be 50 and 80 RPM. For each subject the running order (50 and 80, 80 and 50) is randomly determined
pedal rate on 80 RPMProcedure or surgery
All measurements are performed in two pedalling situations. The two frequencies used will be 50 and 80 RPM. For each subject the running order (50 and 80, 80 and 50) is randomly determined
| Study group | Role | What they receive |
|---|---|---|
| pedal rate ON 50 RPM | Experimental | Not described Receives: Procedure: pedal rate on 50 RPM |
| pedal rate on 80 RPM | Experimental | Not described Receives: Procedure: pedal rate on 80 RPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption (VO2 ml/min)
Oxygen consumption (VO2) is continuously assesse during exercises at 50 and 80 rpm.
Measured: at day 1
Secondary outcomes (4)
Cardiac output( l/min)
Measured: at day 1
muscular oxygen kinetic (arbitrary unit and %)
Measured: at day 1
Muscular activity (mV)
Muscular activity is measured during one and half minute, at the end of each stage
Measured: at day 1 during one and half minute (1min30s)
VO2 (ml/min)
VO2 is continously assessed during the constant-load exercise
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594657
- Sponsor's protocol ID
- CHU-0241
- Acronym
- PRIOx
- Status last verified
- Jul 2016
- First submitted
- 9 Jul 2015
- Last updated
- 29 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pedal Rate Influence on Oxygen Consumption in Eccentric
- ClinicalTrials.gov ID
- NCT02594657
- Acronym / sponsor ID
- PRIOx / CHU-0241
- Conditions
- Healthy
- Keywords
- Eccentric, Ergometer, Pedal rate, Oxygen consumption, Only health volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 3 Nov 2015 (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.
Nowadays, ECC exercise can be realized using various modalities that target small or large muscle masses in a segmentary or dynamic way. The training program proposed in this study is realised on an handmade ergocycle which allows eccentric contractions.
With this type of ergometer, O2 consumption (VO2) is three to five fold lower than during an exercise realised at the same power output with a concentric ergocycle. Due to this later propertie, which origins are not yet fully identified, there is an increasing interest to embed ECC in rehabilitation programs.
The investigators hypothesis that a higher pedal rate will induce a lower oxygen consumption, with the same benefits.
This study aims to compare oxygen consumption at two pedal rates : 50 and 80 rotation per minute (rpm).
The ultimate goal is to assess efficacy and tolerance of eccentric training on ergocycle and to enhance comprehension of the physiological mecanisms involved in the lower O2 consumption observed.
Detailed description
The training program proposed in this study is realised on an handmade ergocycle which allows almost pur eccentric contractions.
Fifteen healthy volunteers realize a incremental test until exertion on a concentric ergometer. If the minimal power output of 200W is reached, the volunteers are familiarized with eccentric exercise during several bouts of exercise. This habituation session allows avoiding the secondary muscular effects of high intensity eccentric exercise.
Then, volunteers could take part in a two-stepped eccentric protocol: 1) an incremental test consisting in 3 stages. Each stage lasts 4 minutes.
- A constant-load test realized at 320W during 6 minutes. Each test is realized twice: at 50 and 80 rpm and sequence is randomly assigned.
[One step (incremental or constant load) = two tests (50 and 80 rpm)]
During each step, oxygen consumption is continuously measured, as well as cardiac output and muscular activity and intramuscular oxygen kinetic.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pedal rate ON 50 RPM | Experimental | Procedure: pedal rate on 50 RPM |
| pedal rate on 80 RPM | Experimental | Procedure: pedal rate on 80 RPM |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- - Males
- IMC <30
- physically active
- Pmax concentric > 200W
- Pmax > Pmax théo sédentaire
Key exclusion criteria (2 listed)
- cardio pulmonary, osteo articulary or muscular diseases
- Eccentric based physical activities or sports (weight liftering, alpine skiing)
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 |
|---|---|---|
| pedal rate on 50 RPMAll measurements are performed in two pedalling situations. The two frequencies used will be 50 and 80 RPM. For each subject the running order (50 and 80, 80 and 50) is randomly determined | Procedure or surgery | pedal rate ON 50 RPM |
| pedal rate on 80 RPMAll measurements are performed in two pedalling situations. The two frequencies used will be 50 and 80 RPM. For each subject the running order (50 and 80, 80 and 50) is randomly determined | Procedure or surgery | pedal rate on 80 RPM |
Primary outcome
Oxygen consumption (VO2 ml/min)
Time frame: at day 1
Oxygen consumption (VO2) is continuously assesse during exercises at 50 and 80 rpm.
4 secondary outcomes
Cardiac output( l/min)
Time frame: at day 1
muscular oxygen kinetic (arbitrary unit and %)
Time frame: at day 1
Muscular activity (mV)
Time frame: at day 1 during one and half minute (1min30s)
VO2 (ml/min)
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pedal rate on 50 RPM and pedal rate on 80 RPM in people with Healthy, run by University Hospital, Clermont-Ferrand 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Jul 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen consumption (VO2 ml/min) (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2016.