ObesityNCT04209647
A Comparison of Continuous Moderate Training and Reduced High Intensity Interval Training in Obese Young Adults
A study testing REHIT Exercise and Continuous Aerobic Exercise in people with Obesity and Exercise, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Exercise is a key component of obesity management. Obese subjects cannot attend or sustain exercise program because of increased general fatigue, dyspnea and muscle fatigue. And they feel more exertion when comparing with normal weight subjects. Read more about this study
- Who is it for?
- Ages 18 to 22 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Exercise, Oxygen Consumption
- What is being tested?
- REHIT Exercise and Continuous Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 1 Aug 2019
- 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 22 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-22,
- BMI ≥ 30,
- Female gender,
Who cannot join
- Smoking history,
- Having any metabolic disease except obesity,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Reduced HIIT and Moderate Intensity Continuous Exercise in Obese Young Adults
Exercise is a key component of obesity management. Obese subjects cannot attend or sustain exercise program because of increased general fatigue, dyspnea and muscle fatigue. And they feel more exertion when comparing with normal weight subjects. Reduced-exertion high-intensity interval training (REHIT) is a alternative method to continuous exercise programs. The investigators aimed comparing metabolic effects of REHIT and continuous exercise in young adults, in this study.
- Conditions
- Obesity, Exercise, Oxygen Consumption
- Being tested
- REHIT Exercise, Continuous Aerobic Exercise
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REHIT ExerciseOther
-Start with warm-up period --> %50 of maximum work rate, 3 minutes
One Exercise Cycle consists of:
- 15 seconds exercise period: %100 of maximum work rate
- 15 seconds recovery period: %50 of maximum work rate
Total Duration: 10 minutes
Continuous Aerobic ExerciseOther
At %50 of maximum heart rate, 30-60 minutes aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| Continuous Exercise | Active comparator | At %60 of maximal heart rate, 30-60 minutes exercise Receives: Other: Continuous Aerobic Exercise |
| REHIT Exercise | Experimental | At %100 of heart rate 15 seconds, after this period 15 sec recovery period for all step Receives: Other: REHIT Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Capacity
Maximum Oxygen Uptake
Measured: 1 year
Secondary outcomes (1)
Total Exercise Duration
Exercise Test Duration
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start1 May 2018
- Primary completion1 Apr 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Çırak, Istinye University
- Investigators
- Nurgul Durustkan Elbasi, PhD, Study chair, Istinye UniversityYunus Emre Tutuneken, PT, Study chair, Istinye UniversityYasemin Cirak, Ass Prof, Principal investigator, Istınye UDuygu Korkem, PhD, Study chair, University of Health scienceBeyza Karaduz, MsC, Study chair, Hacettepe UniversityEbru Calik Kutukcu, PhD, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209647
- Sponsor's protocol ID
- 0004
- Status last verified
- Jul 2020
- First submitted
- 20 Dec 2019
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Reduced HIIT and Moderate Intensity Continuous Exercise in Obese Young Adults
- ClinicalTrials.gov ID
- NCT04209647
- Acronym / sponsor ID
- 0004
- Conditions
- Obesity, Exercise, Oxygen Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 24 Dec 2019 (actual)
- 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 is a key component of obesity management. Obese subjects cannot attend or sustain exercise program because of increased general fatigue, dyspnea and muscle fatigue. And they feel more exertion when comparing with normal weight subjects. Reduced-exertion high-intensity interval training (REHIT) is a alternative method to continuous exercise programs. The investigators aimed comparing metabolic effects of REHIT and continuous exercise in young adults, in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Exercise | Active comparator | Other: Continuous Aerobic ExerciseAt %60 of maximal heart rate, 30-60 minutes exercise |
| REHIT Exercise | Experimental | Other: REHIT ExerciseAt %100 of heart rate 15 seconds, after this period 15 sec recovery period for all step |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between the ages of 18-22,
- BMI ≥ 30,
- Female gender,
Key exclusion criteria (2 listed)
- Smoking history,
- Having any metabolic disease except obesity,
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 |
|---|---|---|
| REHIT Exercise-Start with warm-up period --> %50 of maximum work rate, 3 minutes One Exercise Cycle consists of: * 15 seconds exercise period: %100 of maximum work rate * 15 seconds recovery period: %50 of maximum work rate Total Duration: 10 minutes | Other | REHIT Exercise |
| Continuous Aerobic ExerciseAt %50 of maximum heart rate, 30-60 minutes aerobic exercise | Other | Continuous Exercise |
Primary outcome
Aerobic Capacity
Time frame: 1 year
Maximum Oxygen Uptake
1 secondary outcome
Total Exercise Duration
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
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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.
Nurgul Durustkan Elbasi, PhD study chair
Istinye University
Yunus Emre Tutuneken, PT study chair
Istinye University
Yasemin Cirak, Ass Prof principal investigator
Istınye U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REHIT Exercise and Continuous Aerobic Exercise in people with Obesity and Exercise, run by Istinye University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 30 Jul 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Aerobic Capacity (time frame: 1 year). 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 30 Jul 2020.