ObesityHYPINTNCT02642705
High Intensity Interval Training and Hypoxic Conditioning in Obese Patients
A study testing High intensity interval training N, High intensity interval training H and Constant load exercise training N in people with Obesity, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The present study aims at evaluating the effect of two innovative treatment strategies in obese patients: high intensity interval training and hypoxic conditioning. Obese patients will be randomized in groups performing high intensity interval training, constant load training, hypoxic conditioning or placebo normoxic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- High intensity interval training N, High intensity interval training H and Constant load exercise training N
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Apr 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI between 27 and 35 kg/m²
- Physical activity <2 hours/week
- No chronic disease or treatment able to interfere with inflammation and metabolic perturbatiosn associated with obesity
Who cannot join
- Diabetes mellitus treated with insulin
- Auto-immune or inflammatory diseases requiring long term therapy
- Unstable dysthyroidism
- Bariatric surgery within the past 18 months
- Tumoral, inflammatory, infectious, cardiac, respiratory, kidney, digestive disease
- Untreated sleep apnea
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Grenoble University Hospital
Grenoble, Auvergne-Rhône-Alpes, 38000
Samuel Verges, PhD, 0476766860, sverges@chu-grenoble.fr
About this study
Official title: New Treatment Modalities in Obese Patients: High Intensity Interval Training and Hypoxic Conditioning
The present study aims at evaluating the effect of two innovative treatment strategies in obese patients: high intensity interval training and hypoxic conditioning. Obese patients will be randomized in groups performing high intensity interval training, constant load training, hypoxic conditioning or placebo normoxic conditioning for 8 weeks. The effects of the interventions will be measured regarding exercise tolerance, blood pressure, body composition, metabolic status.
Read the detailed description
120 obese patients will be randomized to 6 intervention groups. Each group will follow an 8-week intervention (3 session per week) with either high intensity interval training in normoxia or hypoxia, constant load exercise training in normoxia or hypoxia, hypoxic or normoxic (placebo) conditioning at rest. Exercise capacity, metabolic status, blood pressure, vascular function and physical activity will be assessed before and after the intervention.
- Conditions
- Obesity
- Being tested
- High intensity interval training N, High intensity interval training H, Constant load exercise training N, Constant load exercise training H, Hypoxic conditioning at rest
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval training NOther
Exercise training and ambient air breathing
High intensity interval training HOther
Exercise training and hypoxic breathing
Constant load exercise training NOther
Exercise training and ambient air breathing
Constant load exercise training HOther
Exercise training and hypoxic breathing
Hypoxic conditioning at restOther
Hypoxic breathing at rest
Normoxic conditioning at restOther
Normoxic breathing at rest (placebo)
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval training N | Experimental | High intensity interval training N: The intervention consists in 8-week exercise training, 3 times a week for one hour, according to a high intensity interval training protocol (1 min ON at 100% maximal power output, 1 min OFF), breathing ambient air (normoxia) Receives: Other: High intensity interval training N |
| High intensity interval training H | Experimental | High intensity interval training H: The intervention consists in 8-week exercise training, 3 times a week for one hour, according to a high intensity interval training protocol (1 min ON at 100% maximal power output, 1 min OFF), breathing hypoxic air (about 3 500 m of altitude) Receives: Other: High intensity interval training H |
| Constant load exercise training N | Active comparator | Constant load exercise training N: The intervention consists in 8-week exercise training, 3 times a week for one hour, according to a constant load training protocol (50% maximal power output), breathing ambient air (normoxia) Receives: Other: Constant load exercise training N |
| Constant load exercise training H | Experimental | Constant load exercise training H: The intervention consists in 8-week exercise training, 3 times a week for one hour, according to a constant load training protocol (50% maximal power output), breathing hypoxic air (about 3 500 m of altitude) Receives: Other: Constant load exercise training H |
| Hypoxic conditioning at rest | Experimental | Hypoxic conditioning at rest : The intervention consists in 8-week conditioning period, 3 times a week, hypoxic breathing for one hour (about 4500 m of altitude) while seating quietly Receives: Other: Hypoxic conditioning at rest |
| Normoxic conditioning at rest | Sham comparator | Normoxic conditioning at rest : The intervention consists in 8-week conditioning period, 3 times a week, normoxic breathing for one hour (ambient air) while seating quietly Receives: Other: Normoxic conditioning at rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal exercise capacity
Maximal oxygen consumption during an incremental exercise test
Measured: 8 weeks
Secondary outcomes (5)
Metabolic status
Blood lipids, glycemia, HOMA index, oxydative stress and inflammatory status
Measured: 8 weeks
Body composition
MRI fat free mass and adipose tissue measurements
Measured: 8 weeks
Blood pressure
24 h ambulatory blood pressure mesurement
Measured: 8 weeks
Vascular function
Post-ischemic hyperemia (Endo-Pat) and pulse wave velocity
Measured: 8 weeks
Physical activity
Spontaneous physical activity measured by accelerometry
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard Wuyam, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642705
- Sponsor's protocol ID
- 2014-A01482-45
- Acronym
- HYPINT
- Status last verified
- Mar 2020
- First submitted
- 24 Dec 2015
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Verges S, Chacaroun S, Godin-Ribuot D, Baillieul S. Hypoxic Conditioning as a New Therapeutic Modality. Front Pediatr. 2015 Jun 22;3:58. doi: 10.3389/fped.2015.00058. eCollection 2015.
PubMed 26157787Weston KS, Wisloff U, Coombes JS. High-intensity interval training in patients with lifestyle-induced cardiometabolic disease: a systematic review and meta-analysis. Br J Sports Med. 2014 Aug;48(16):1227-34. doi: 10.1136/bjsports-2013-092576. Epub 2013 Oct 21.
PubMed 24144531
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Treatment Modalities in Obese Patients: High Intensity Interval Training and Hypoxic Conditioning
- ClinicalTrials.gov ID
- NCT02642705
- Acronym / sponsor ID
- HYPINT / 2014-A01482-45
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 30 Dec 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.
The present study aims at evaluating the effect of two innovative treatment strategies in obese patients: high intensity interval training and hypoxic conditioning. Obese patients will be randomized in groups performing high intensity interval training, constant load training, hypoxic conditioning or placebo normoxic conditioning for 8 weeks. The effects of the interventions will be measured regarding exercise tolerance, blood pressure, body composition, metabolic status.
Detailed description
120 obese patients will be randomized to 6 intervention groups. Each group will follow an 8-week intervention (3 session per week) with either high intensity interval training in normoxia or hypoxia, constant load exercise training in normoxia or hypoxia, hypoxic or normoxic (placebo) conditioning at rest. Exercise capacity, metabolic status, blood pressure, vascular function and physical activity will be assessed before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| High intensity interval training N | Experimental | Other: High intensity interval training NHigh intensity interval training N: The intervention consists in 8-week exercise training, 3 times a week for one hour, according to a high intensity interval training protocol (1 min ON at 100% maximal power output, 1 min OFF), breathing ambient air (normoxia) |
| High intensity interval training H | Experimental | Other: High intensity interval training HHigh intensity interval training H: The intervention consists in 8-week exercise training, 3 times a week for one hour, according to a high intensity interval training protocol (1 min ON at 100% maximal power output, 1 min OFF), breathing hypoxic air (about 3 500 m of altitude) |
| Constant load exercise training N | Active comparator | Other: Constant load exercise training NConstant load exercise training N: The intervention consists in 8-week exercise training, 3 times a week for one hour, according to a constant load training protocol (50% maximal power output), breathing ambient air (normoxia) |
| Constant load exercise training H | Experimental | Other: Constant load exercise training HConstant load exercise training H: The intervention consists in 8-week exercise training, 3 times a week for one hour, according to a constant load training protocol (50% maximal power output), breathing hypoxic air (about 3 500 m of altitude) |
| Hypoxic conditioning at rest | Experimental | Other: Hypoxic conditioning at restHypoxic conditioning at rest : The intervention consists in 8-week conditioning period, 3 times a week, hypoxic breathing for one hour (about 4500 m of altitude) while seating quietly |
| Normoxic conditioning at rest | Sham comparator | Other: Normoxic conditioning at restNormoxic conditioning at rest : The intervention consists in 8-week conditioning period, 3 times a week, normoxic breathing for one hour (ambient air) while seating quietly |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI between 27 and 35 kg/m²
- Physical activity <2 hours/week
- No chronic disease or treatment able to interfere with inflammation and metabolic perturbatiosn associated with obesity
Key exclusion criteria (6 listed)
- Diabetes mellitus treated with insulin
- Auto-immune or inflammatory diseases requiring long term therapy
- Unstable dysthyroidism
- Bariatric surgery within the past 18 months
- Tumoral, inflammatory, infectious, cardiac, respiratory, kidney, digestive disease
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 |
|---|---|---|
| High intensity interval training NExercise training and ambient air breathing | Other | High intensity interval training N |
| High intensity interval training HExercise training and hypoxic breathing | Other | High intensity interval training H |
| Constant load exercise training NExercise training and ambient air breathing | Other | Constant load exercise training N |
| Constant load exercise training HExercise training and hypoxic breathing | Other | Constant load exercise training H |
| Hypoxic conditioning at restHypoxic breathing at rest | Other | Hypoxic conditioning at rest |
| Normoxic conditioning at restNormoxic breathing at rest (placebo) | Other | Normoxic conditioning at rest |
Primary outcome
Maximal exercise capacity
Time frame: 8 weeks
Maximal oxygen consumption during an incremental exercise test
5 secondary outcomes
Metabolic status
Time frame: 8 weeks
Body composition
Time frame: 8 weeks
Blood pressure
Time frame: 8 weeks
Vascular function
Time frame: 8 weeks
Physical activity
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Background: PubMed 26157787Verges S, Chacaroun S, Godin-Ribuot D, Baillieul S. Hypoxic Conditioning as a New Therapeutic Modality. Front Pediatr. 2015 Jun 22;3:58. doi: 10.3389/fped.2015.00058. eCollection 2015.
- Background: PubMed 24144531Weston KS, Wisloff U, Coombes JS. High-intensity interval training in patients with lifestyle-induced cardiometabolic disease: a systematic review and meta-analysis. Br J Sports Med. 2014 Aug;48(16):1227-34. doi: 10.1136/bjsports-2013-092576. Epub 2013 Oct 21.
- Individual participant dataSharing planned: No
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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.
Bernard Wuyam, MD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval training N, High intensity interval training H and Constant load exercise training N in people with Obesity, run by University Hospital, Grenoble 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 6 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 18 Mar 2020. 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. Some participants in this study may receive a placebo. 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 Samuel Verges, PhD (0476766860, sverges@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal exercise capacity (time frame: 8 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 NCT02642705, which also lists 2 linked publications.
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 18 Mar 2020.