Exercise OvertrainingNCT06538714
Interval Training and Cardio-metabolic Health in Overweight/Obese Girls
A study testing MIIT and MIIT + HIIT in people with Exercise Overtraining and Enjoyment, run by Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose at 2 sites in Tunisia.
Trial summary
The main purpose of this study is to compare the impact of 12-week moderate-intensity interval training (MIIT) versus combined MIIT with high-intensity interval training (HIIT) on physical fitness, cardio metabolic, lipidomic, hematological and psychological characteristics in young overweight/obese girls. Read more about this study
- Who is it for?
- Ages 12 to 15 years, women only
- Conditions the study is for
- Exercise Overtraining, Enjoyment, Cardiometabolic Syndrome
- What is being tested?
- MIIT and MIIT + HIIT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesTunisia
- Study dates
- 20 May 2024to 19 Aug 2024
- 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 12 to 15 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Female gender,
- Overweight or obese according to the BMI classification,
- Age, 12 to 15 years,
- Personal or parental/guardian written consent
Who cannot join
- Severe infectious or inflammatory diseases,
- Irregular menstrual cycles
- Participation in organized exercise training in the last 6 months or additional physical -
- recreational activities, except physical education classes.
- Using medications, hormone therapy or dietary supplements
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites, 2 recruiting
- Recruiting
ATERA : Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
Tunis, 1007
Amani Kallel, PhD, +21696872787, kalamany2@gmail.com
Riadh Jemaa, PhD, +21698819168, jemaa_riadh@yahoo.fr
- Recruiting
Rabta Hospital
Tunis, 1007
Amani Kallel, PhD, 96872787 ext. 216, amani.kallel@fmt.utm.tn
About this study
Official title: Impact of Different Interval Training Protocols on Physical, Cardio-metabolic, Lipidomic, Hematological and Psychological Parameters in Young Overweight/Obese Girls
The main purpose of this study is to compare the impact of 12-week moderate-intensity interval training (MIIT) versus combined MIIT with high-intensity interval training (HIIT) on physical fitness, cardio metabolic, lipidomic, hematological and psychological characteristics in young overweight/obese girls.
- Conditions
- Exercise Overtraining, Enjoyment, Cardiometabolic Syndrome, Obesity
- Being tested
- MIIT, MIIT + HIIT, Control group
- Keywords
- interval training, obesity, overweight, childhood, cardiometabolic risk, enjoyement, lipidomics, body composition, physical fitness
- Medical subject headings
- Overtraining Syndrome, Metabolic Syndrome, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIITOther
12-week supervised exercise program consisting of moderate-intensity interval training (MIIT)
MIIT: 3 series of 4-8 repetitions of 30-s of work at 70-75% of MAS and 30-s of active recovery at 50% of MAS.
3 exercise sessions per week.
Additionally, participants receive no individualized nutritional counseling.
MIIT + HIITOther
12-week supervised exercise program consisting of moderate-intensity interval training (MIIT) (6-week) and high-intensity interval training (HIIT) (6-week).
MIIT: 3 series of 4-8 repetitions of 30-s of work at 70-75% of MAS and 30-s of active recovery at 50% of MAS.
HIIT: 3 series of 5 repetitions of 30-s of work at 100% of MAS and 30-s of active recovery at 50% of MAS for weeks 7-9, as well as two series of 10 repetitions of 30-s of work at 100% of MAS and 30-s of active recovery at 50% of MAS for weeks 10-12.
3 exercise sessions per week. Additionally, participants receive no individualized nutritional counseling.
Control groupOther
Habitual physical activity No additional physical intervention
Additionally, participants receive no individualized nutritional counseling.
| Study group | Role | What they receive |
|---|---|---|
| MIIT | Experimental | 12-week supervised exercise program consisting of moderate -intensity interval training (MIIT) Receives: Other: MIIT |
| MIIT+ HIIT | Active comparator | 12-week supervised exercise program consisting of moderate-intensity interval training (MIIT) (6-week) and high-intensity interval training (HIIT) (6-week). Receives: Other: MIIT + HIIT |
| Control group No training | Placebo comparator | Not described Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index (BMI)
measures of weight in kilograms, height in meters, calculation of BMI in kg/m^2)
Measured: 12 weeks
Changes in plasma triglycerides
will be assessed using an Alinity-Abbott autoanalyzer
Measured: 12 weeks
Enjoyment
Enjoyment will be measured using the validated Physical Activity Enjoyment Scale. This scale was used to assess the level of enjoyment following interventions using the participants' responses to 18 items rated on a 7-point bipolar rating scale. The assessment consists of questions relateding to the enjoyment after intervention with the instruction, "Please rate how you feel about the physical activity you have been doing at the moment about the physical activity you have been doing". An overallOverall enjoyment of physical activity score was generated by summing the individual item scores. Scores ranged from 18-126, with higher scores reflecting higher levels of enjoyment.
Measured: 6 and 12 weeks
Secondary outcomes (5)
Changes in Aerobic velocity
Aerobic velocity will be measured with incremental running test "the Spartacus test". This test is validated for the evaluation of aerobic capacity for obese adolescents. A rectangle of 750 m (75 × 10 m) will be created with different marks set at regular intervals, which represent the different speeds (from 7 to 18 km/h). Each stage lasts three minutes whereby the first stage is set at 7 km/h and each following stage increasing by 1 km/h. During each stage, the participant had 15 s to reach the corresponding mark and then 15 s of rest. Participants adjusted their running speed simultaneously to cones and audio beep. The test ended when the subject was no longer able to maintain the pace for two consecutive occasions or when he decided to stop due to exhaustion.
Measured: 6 and 12 weeks
Changes in lipidomic profile
Lipidomic profile will be assessed by measuring selected plasma polyunsaturated fatty acids (PUFAs), oxylipins and endocabnnabinnoids by LC-MS/MS method
Measured: 12 weeks
Changes in hematological parameters
Hematological parameters included red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, leukocyte count , neutrophil count , lymphocyte count, monocyte count , eosinophil count and platelet count will be measured using an automated cell counter (Sysmex XN450; Norderstedt, Germany).
Measured: 12 weeks
Change in Heart rate
Heart rate will be recorded using a heart rate monitor (S810, Polar, Kempele, Finland) during the incremental running test "the Spartacus test".
Measured: 12 weeks
Change in sprint performance
Sprinting performance will be evaluated by 10-m, 20-m, 30 --m and 60-m sprints, using a series of paired photocells with an accuracy of 0.01 s (Brower Timing System, Salt Lake City, UT).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start20 May 2024
- Primary completion20 Jun 2024
- Study completion19 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise OvertrainingStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538714
- Sponsor's protocol ID
- CERB 16/2024
- Status last verified
- Jul 2024
- First submitted
- 14 Jun 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Interval Training Protocols on Physical, Cardio-metabolic, Lipidomic, Hematological and Psychological Parameters in Young Overweight/Obese Girls
- ClinicalTrials.gov ID
- NCT06538714
- Acronym / sponsor ID
- CERB 16/2024
- Conditions
- Exercise Overtraining, Enjoyment, Cardiometabolic Syndrome, Obesity
- Keywords
- interval training, obesity, overweight, childhood, cardiometabolic risk, enjoyement, lipidomics, body composition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Association Tunisienne d'Etude & de Recherche sur l'AthéroscléroseUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 19 Aug 2024 (estimated)
- First posted
- 6 Aug 2024 (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.
The main purpose of this study is to compare the impact of 12-week moderate-intensity interval training (MIIT) versus combined MIIT with high-intensity interval training (HIIT) on physical fitness, cardio metabolic, lipidomic, hematological and psychological characteristics in young overweight/obese girls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MIIT | Experimental | Other: MIIT12-week supervised exercise program consisting of moderate -intensity interval training (MIIT) |
| MIIT+ HIIT | Active comparator | Other: MIIT + HIIT12-week supervised exercise program consisting of moderate-intensity interval training (MIIT) (6-week) and high-intensity interval training (HIIT) (6-week). |
| Control group No training | Placebo comparator | Other: Control group |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Female gender,
- Overweight or obese according to the BMI classification,
- Age, 12 to 15 years,
- Personal or parental/guardian written consent
Key exclusion criteria (5 listed)
- Severe infectious or inflammatory diseases,
- Irregular menstrual cycles
- Participation in organized exercise training in the last 6 months or additional physical -
- recreational activities, except physical education classes.
- Using medications, hormone therapy or dietary supplements
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 |
|---|---|---|
| MIIT12-week supervised exercise program consisting of moderate-intensity interval training (MIIT) MIIT: 3 series of 4-8 repetitions of 30-s of work at 70-75% of MAS and 30-s of active recovery at 50% of MAS. 3 exercise sessions per week. Additionally, participants receive no individualized nutritional counseling. | Other | MIIT |
| MIIT + HIIT12-week supervised exercise program consisting of moderate-intensity interval training (MIIT) (6-week) and high-intensity interval training (HIIT) (6-week). MIIT: 3 series of 4-8 repetitions of 30-s of work at 70-75% of MAS and 30-s of active recovery at 50% of MAS. HIIT: 3 series of 5 repetitions of 30-s of work at 100% of MAS and 30-s of active recovery at 50% of MAS for weeks 7-9, as well as two series of 10 repetitions of 30-s of work at 100% of MAS and 30-s of active recovery at 50% of MAS for weeks 10-12. 3 exercise sessions per week. Additionally, participants receive no individualized nutritional counseling. | Other | MIIT+ HIIT |
| Control groupHabitual physical activity No additional physical intervention Additionally, participants receive no individualized nutritional counseling. | Other | Control group No training |
Primary outcome
Change in body mass index (BMI)
Time frame: 12 weeks
measures of weight in kilograms, height in meters, calculation of BMI in kg/m^2)
Changes in plasma triglycerides
Time frame: 12 weeks
will be assessed using an Alinity-Abbott autoanalyzer
Enjoyment
Time frame: 6 and 12 weeks
Enjoyment will be measured using the validated Physical Activity Enjoyment Scale. This scale was used to assess the level of enjoyment following interventions using the participants' responses to 18 items rated on a 7-point bipolar rating scale. The assessment consists of questions relateding to the enjoyment after intervention with the instruction, "Please rate how you feel about the physical activity you have been doing at the moment about the physical activity you have been doing". An overallOverall enjoyment of physical activity score was generated by summing the individual item scores. Scores ranged from 18-126, with higher scores reflecting higher levels of enjoyment.
5 secondary outcomes
Changes in Aerobic velocity
Time frame: 6 and 12 weeks
Changes in lipidomic profile
Time frame: 12 weeks
Changes in hematological parameters
Time frame: 12 weeks
Change in Heart rate
Time frame: 12 weeks
Change in sprint performance
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIIT and MIIT + HIIT in people with Exercise Overtraining and Enjoyment, run by Association Tunisienne d'Etude & de Recherche sur l'Athérosclérose at 2 sites in Tunisia.
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 4 inclusion and 5 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 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. 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 Amani Kallel, PhD (96872787 ext. 216, amani.kallel@fmt.utm.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass index (BMI) (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 6 Aug 2024.