AquacyclingNCT02895217
Aquatic Exercise and Metabolism in Women
A study testing ergocycle in people with Aquacycling, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Exercise training on an immersible ergocycle is becoming more popular as it appears to be more suitable for men and women even with poor physical activity level. Commercial tagline highlight beneficial effect of this activity on weight management. Read more about this study
- Who is it for?
- Ages 23 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aquacycling
- What is being tested?
- ergocycle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Jun 2018
- 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 23 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged between 23 and 40 years
- BMI under 25kg.m2 for normal weight women and between 25 and 29,9 kg.m2 for overweight women
- Daily breakfast
- Subject which approved informed consent
- Subject with French medical affiliation
Who cannot join
- Specific medical treatment
- Aquaphobia
- Subject under specific diet regimen or weight loss program
- Subject with cardio-vascular disease
- Surgical intervention less than 3 months
- Subject refusing informed and written consent
Show all 11Show fewer
- Subject without French medical affiliation
- subject refusing inscription to the national voluntary list
- subject being in an exclusion period
- subject smoking or drinking alcohol frequently
- subject with intense physical activity
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
Martine DUCLOS
About this study
Official title: Evaluation of Energy Balance During Aquatic Cycling Exercise in Premenopausal Women: Effect of Body Composition Status
Exercise training on an immersible ergocycle is becoming more popular as it appears to be more suitable for men and women even with poor physical activity level. Commercial tagline highlight beneficial effect of this activity on weight management. However there are poor information concerning the energy response induced by this activity. The aim of this project is to investigate energetic response (energy expenditure and food intake) of a single bout of cycling exercise in water vs on dryland in normal weight and overweight premenopausal women.
Read the detailed description
After inclusion visit, all subject will be submitted to DXA to obtain body composition data. Then subjects will be submitted to four experimental session in a semi-randomized order. For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session.
Control session (CON): subject will stand sited without any activity during 30 min.
Water exercise session (WAT): subject will exercise on an immersed ergocycle during 30 min at 50 rpm.
Dryland session 1 (LAND-1): subject will exercise on dryland, on the same ergocycle than in WAT session, during 30 min at 50 rpm.
Dryland session 2 (LAND-2): subject will exercise on dryland on the same ergocycle than in WAT. Intensity of exercise will be set at the same heart rate average than in WAT session, exercise will be stopped when subject will have reached the same energy expenditure than during WAT session.
During each session, energy expenditure, heart rate and rate of perceived exertion will be measured at 15 min and 30min.
Appetite and hunger sensation will be measured with a specific scale at different time point of each day of experimental session. Thirty minutes after the end of each experimental session subjects will have a buffet meal for lunch time.
- Conditions
- Aquacycling
- Being tested
- ergocycle
- Keywords
- Energy expenditure, Food intake, Women, aquacycling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ergocycleOther
| Study group | Role | What they receive |
|---|---|---|
| Cycling exercise in water | Experimental | The aim of this project is to investigate energetic response (energy expenditure and food intake) of a single bout of cycling exercise in water vs on dryland in normal weight and overweight premenopausal women. Receives: Other: ergocycle |
| cycling exercise on dryland | Experimental | The aim of this project is to investigate energetic response (energy expenditure and food intake) of a single bout of cycling exercise in water vs on dryland in normal weight and overweight premenopausal women. Receives: Other: ergocycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake during buffet meal
during buffet meal 30 min after the end of each experimental session
Measured: at day 1
Secondary outcomes (4)
Appetite sensation
during each session (before and after breakfast, before and after experimental session, 30 min after the experimental session, 30min after the end of buffet meal at lunch time) . Each sensation is measured with a visual analogue scale
Measured: at day 1
Energy expenditure in kcal
during each session (during each 30min session measured by indirect calorimetry)
Measured: at day 1
Rate of perceived exertion
during each session
Measured: at day 1
hunger sensation
during each session( before and after breakfast, before and after experimental session, 30 min after the experimental session, 30min after the end of buffet meal at lunch time)
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 posted9 Sep 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
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 AquacyclingStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine DUCLOS, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895217
- Sponsor's protocol ID
- CHU-0272
- Other IDs
- 2016-A00197-44
- Status last verified
- Sep 2016
- First submitted
- 12 Jul 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
Publications
Brechat PH, Wolf JP, Simon-Rigaud ML, Brechat N, Kantelip JP, Berthelay S, Regnard J. Influence of immersion on respiratory requirements during 30-min cycling exercise. Eur Respir J. 1999 Apr;13(4):860-6. doi: 10.1034/j.1399-3003.1999.13d28.x.
PubMed 10362054
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Energy Balance During Aquatic Cycling Exercise in Premenopausal Women: Effect of Body Composition Status
- ClinicalTrials.gov ID
- NCT02895217
- Acronym / sponsor ID
- CHU-0272
- Conditions
- Aquacycling
- Keywords
- Energy expenditure, Food intake, Women, aquacycling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 9 Sep 2016 (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.
Exercise training on an immersible ergocycle is becoming more popular as it appears to be more suitable for men and women even with poor physical activity level. Commercial tagline highlight beneficial effect of this activity on weight management. However there are poor information concerning the energy response induced by this activity. The aim of this project is to investigate energetic response (energy expenditure and food intake) of a single bout of cycling exercise in water vs on dryland in normal weight and overweight premenopausal women.
Detailed description
After inclusion visit, all subject will be submitted to DXA to obtain body composition data. Then subjects will be submitted to four experimental session in a semi-randomized order. For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session.
Control session (CON): subject will stand sited without any activity during 30 min.
Water exercise session (WAT): subject will exercise on an immersed ergocycle during 30 min at 50 rpm.
Dryland session 1 (LAND-1): subject will exercise on dryland, on the same ergocycle than in WAT session, during 30 min at 50 rpm.
Dryland session 2 (LAND-2): subject will exercise on dryland on the same ergocycle than in WAT. Intensity of exercise will be set at the same heart rate average than in WAT session, exercise will be stopped when subject will have reached the same energy expenditure than during WAT session.
During each session, energy expenditure, heart rate and rate of perceived exertion will be measured at 15 min and 30min.
Appetite and hunger sensation will be measured with a specific scale at different time point of each day of experimental session. Thirty minutes after the end of each experimental session subjects will have a buffet meal for lunch time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycling exercise in water | Experimental | Other: ergocycleThe aim of this project is to investigate energetic response (energy expenditure and food intake) of a single bout of cycling exercise in water vs on dryland in normal weight and overweight premenopausal women. |
| cycling exercise on dryland | Experimental | Other: ergocycleThe aim of this project is to investigate energetic response (energy expenditure and food intake) of a single bout of cycling exercise in water vs on dryland in normal weight and overweight premenopausal women. |
Who may qualify
- Ages
- 23 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged between 23 and 40 years
- BMI under 25kg.m2 for normal weight women and between 25 and 29,9 kg.m2 for overweight women
- Daily breakfast
- Subject which approved informed consent
- Subject with French medical affiliation
Key exclusion criteria (11 listed)
- Specific medical treatment
- Aquaphobia
- Subject under specific diet regimen or weight loss program
- Subject with cardio-vascular disease
- Surgical intervention less than 3 months
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 |
|---|---|---|
| ergocycle | Other | Cycling exercise in water, cycling exercise on dryland |
Primary outcome
Food intake during buffet meal
Time frame: at day 1
during buffet meal 30 min after the end of each experimental session
4 secondary outcomes
Appetite sensation
Time frame: at day 1
Energy expenditure in kcal
Time frame: at day 1
Rate of perceived exertion
Time frame: at day 1
hunger sensation
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 9 Sep 2016.
- Background: PubMed 10362054Brechat PH, Wolf JP, Simon-Rigaud ML, Brechat N, Kantelip JP, Berthelay S, Regnard J. Influence of immersion on respiratory requirements during 30-min cycling exercise. Eur Respir J. 1999 Apr;13(4):860-6. doi: 10.1034/j.1399-3003.1999.13d28.x.
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.
Martine DUCLOS principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ergocycle in people with Aquacycling, 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 11 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 9 Sep 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?
Food intake during buffet meal (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?
On the ClinicalTrials.gov record for NCT02895217, 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 9 Sep 2016.