OverweightNCT04932174
High Intensity Interval Training Versus Low-intensity Continuous Training on Physical Fitness Among Overweight Adult
A study testing High-intensity Interval Training and Low-intensity Continuous Training in people with Overweight and Overweight and Obesity, run by Horus University at 1 site in Egypt.
Trial summary
The purpose of the study is to compare the effect of high intensity interval training and low intensity training on physical fitness among adult overweight. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Overweight and Obesity
- What is being tested?
- High-intensity Interval Training and Low-intensity Continuous Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 15 Jul 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) will be ≥ 25 -29.9 kg/m².
- Age will be ranging from 20 to 30 years.
- Waist circumference >88cm2 in men and >102cm2 in women.
- Content of body fat will be assisted by electrical bioimpedence≥33%.
- Stable body weight in the month prior to the trial.
- Follow instructions for healthy life style.
Who cannot join
- Patients with musculoskeletal deformities and disorders.
- Patients with other neuromuscular disorders.
- Patients with foot deformities and ulcers.
- Patients with lower limb operations.
- Smoking cigarettes, thyroid diseases.
- History of coronary artery disease Asthma, chronic obstructive pulmonary diseases.
- poorly controlled hypertension (mean systolic blood pressure (SBP) > 140 mm Hg and/or mean diastolic blood pressure (DBP) > 90 mm Hg) during the month prior to the trial.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic - Faculty of Physical Therapy - Horus University
Damietta, 34518
Heba Yasser, Demonstrator, +201065015529, hyasser@horus.edu.eg
About this study
Official title: Effect of High Intensity Interval Training Versus Low Intensity Continuous Training on Physical Fitness Among Overweight Adult
The purpose of the study is to compare the effect of high intensity interval training and low intensity training on physical fitness among adult overweight.
Read the detailed description
Excess body weight has been shown to negatively influence musculoskeletal health and may limit physical function. Thus, there is a need for effective interventions to reduce body weight in those individuals who may already be overweight or obese. Physical activity can be an important component of lifestyle interventions for weight loss. Thus, it is important for clinicians, health care providers, and health-fitness professionals to recognize the influence of physical activity on body weight and to understand recommendations that can affect physical activity behavior. Several studies reported that HIIT can improve cardiorespiratory fitness (increase vo2 max) in adults with varied body weight and health status.
High intensity interval training induced improvements in insulin sensitivity, blood pressure, and body composition more consistently occur in adults with overweight, with or without high risk of cardiovascular disease and diabetes especially if these participate in prolonged exercise program up to 12 or more weeks.
Low intensity exercise has been shown to have a range of physiological and biochemical effects during a subsequent bout of exercise Low intensity exercise would result in muscle acetyl group accumulation and thereby would accelerate mitochondrial ATP production (and reduce ATP production from nonoxidative routes) during a subsequent bout of moderate intensity exercise. In accordance with these changes, we also hypothesized that the vo2 on-kinetics during moderate intensity exercise would be accelerated when preceded by low intensity exercise .
The significant behind this study came up with the importance to declare the effect of high intensity interval training on improving physical fitness and body composition which be more suitable for overweight active people that don't have time to practice prolonged exercise during the week and this study also will investigates the effect of low intensity exercise on physical fitness and body composition to declare where is going to be beneficial for overweight sedentary subjects and compare it is effect with pervious.
This study will be designed to provide a guideline about the effect of high intensity interval training\& low intensity training exercise on physical fitness in the overweight adult patient.
- Conditions
- Overweight, Overweight and Obesity
- Being tested
- High-intensity Interval Training, Low-intensity Continuous Training
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity Interval TrainingOther
Consisting of the following program:
- Warming up period for 10 minutes at 60-70% of HR max.
- Training phase 4x4 min intervals at 85-90% of HRmax with a 3 min active recovery at 70% of HRmax between each interval.
- Duration of HIIT 4 minute
- Number of interval per session 4
- Duration of rest interval 3 minute 3-10 min cool-down period, giving a total of 60 min.
Low-intensity Continuous TrainingOther
Consisting of the following program:
- Warming up period for 10 minutes.
- Training phase for 60-minute walking on a treadmill at intensity 40-50% HRR (1- 6) weeks then 60-70% HRR (7-12) weeks.
- cooling down period for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity Interval Training | Experimental | Group 2: the included 15 subjects will participate in High intensity Interval training exercise running on treadmill for 12 weeks, 3 times / week. Receives: Other: High-intensity Interval Training |
| Low-intensity Continuous Training | Active comparator | Group 1: the included 15 subjects will participate in low intensity continuous exercise on treadmill for 12 weeks, 3 times / week Receives: Other: Low-intensity Continuous Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change in body Weight
Assessment via using body weight scale with height (m) scale to be able to calculate body mass index (Kg) to all subjects before starting the study BMI= Weight (KG) /Height2 (M2)
Measured: Baseline and 2 months post-intervention
Assessing the change in Waist hip ratio
Assessment via using was measured to the nearest 0.1 cm by using a flexible steel tape at the level of umbilicus, and hip circumference (HC) was measured at the widest level over the greater trochanters.
Measured: Baseline and 2 months post-intervention
Assessing the change in body fat
Assessment through bioelectrical impedance analysis by using a Body Composition Analyzer (TANITA Corporation, Japan).
Measured: Baseline and 2 months post-intervention
Assessing the change Cardiorespiratory fitness
Assessment via using Shuttle run test The 20-m shuttle run (20MSR) test, also called the ''Course Navette'', "PACER", or "Multistage fitness test", is probably the most widely used field test for estimating cardiorespiratory fitness.
Measured: Baseline and 2 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start1 Apr 2021
- Primary completion30 Jun 2021 (estimated)
- Study completion15 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Yasser, Horus University
- Investigators
- Heba Yasser, Demonstrator, Principal investigator, Horus University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932174
- Sponsor's protocol ID
- Hebayasser_MSc
- Status last verified
- Jun 2021
- First submitted
- 13 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Intensity Interval Training Versus Low Intensity Continuous Training on Physical Fitness Among Overweight Adult
- ClinicalTrials.gov ID
- NCT04932174
- Acronym / sponsor ID
- Hebayasser_MSc
- Conditions
- Overweight, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 21 Jun 2021 (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 purpose of the study is to compare the effect of high intensity interval training and low intensity training on physical fitness among adult overweight.
Detailed description
Excess body weight has been shown to negatively influence musculoskeletal health and may limit physical function. Thus, there is a need for effective interventions to reduce body weight in those individuals who may already be overweight or obese. Physical activity can be an important component of lifestyle interventions for weight loss. Thus, it is important for clinicians, health care providers, and health-fitness professionals to recognize the influence of physical activity on body weight and to understand recommendations that can affect physical activity behavior. Several studies reported that HIIT can improve cardiorespiratory fitness (increase vo2 max) in adults with varied body weight and health status.
High intensity interval training induced improvements in insulin sensitivity, blood pressure, and body composition more consistently occur in adults with overweight, with or without high risk of cardiovascular disease and diabetes especially if these participate in prolonged exercise program up to 12 or more weeks.
Low intensity exercise has been shown to have a range of physiological and biochemical effects during a subsequent bout of exercise Low intensity exercise would result in muscle acetyl group accumulation and thereby would accelerate mitochondrial ATP production (and reduce ATP production from nonoxidative routes) during a subsequent bout of moderate intensity exercise. In accordance with these changes, we also hypothesized that the vo2 on-kinetics during moderate intensity exercise would be accelerated when preceded by low intensity exercise .
The significant behind this study came up with the importance to declare the effect of high intensity interval training on improving physical fitness and body composition which be more suitable for overweight active people that don't have time to practice prolonged exercise during the week and this study also will investigates the effect of low intensity exercise on physical fitness and body composition to declare where is going to be beneficial for overweight sedentary subjects and compare it is effect with pervious.
This study will be designed to provide a guideline about the effect of high intensity interval training\& low intensity training exercise on physical fitness in the overweight adult patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity Interval Training | Experimental | Other: High-intensity Interval TrainingGroup 2: the included 15 subjects will participate in High intensity Interval training exercise running on treadmill for 12 weeks, 3 times / week. |
| Low-intensity Continuous Training | Active comparator | Other: Low-intensity Continuous TrainingGroup 1: the included 15 subjects will participate in low intensity continuous exercise on treadmill for 12 weeks, 3 times / week |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Body mass index (BMI) will be ≥ 25 -29.9 kg/m².
- Age will be ranging from 20 to 30 years.
- Waist circumference >88cm2 in men and >102cm2 in women.
- Content of body fat will be assisted by electrical bioimpedence≥33%.
- Stable body weight in the month prior to the trial.
Key exclusion criteria (7 listed)
- Patients with musculoskeletal deformities and disorders.
- Patients with other neuromuscular disorders.
- Patients with foot deformities and ulcers.
- Patients with lower limb operations.
- Smoking cigarettes, thyroid diseases.
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 TrainingConsisting of the following program: * Warming up period for 10 minutes at 60-70% of HR max. * Training phase 4x4 min intervals at 85-90% of HRmax with a 3 min active recovery at 70% of HRmax between each interval. * Duration of HIIT 4 minute * Number of interval per session 4 * Duration of rest interval 3 minute 3-10 min cool-down period, giving a total of 60 min. | Other | High-intensity Interval Training |
| Low-intensity Continuous TrainingConsisting of the following program: * Warming up period for 10 minutes. * Training phase for 60-minute walking on a treadmill at intensity 40-50% HRR (1- 6) weeks then 60-70% HRR (7-12) weeks. * cooling down period for 10 minutes. | Other | Low-intensity Continuous Training |
Primary outcome
Assessing the change in body Weight
Time frame: Baseline and 2 months post-intervention
Assessment via using body weight scale with height (m) scale to be able to calculate body mass index (Kg) to all subjects before starting the study BMI= Weight (KG) /Height2 (M2)
Assessing the change in Waist hip ratio
Time frame: Baseline and 2 months post-intervention
Assessment via using was measured to the nearest 0.1 cm by using a flexible steel tape at the level of umbilicus, and hip circumference (HC) was measured at the widest level over the greater trochanters.
Assessing the change in body fat
Time frame: Baseline and 2 months post-intervention
Assessment through bioelectrical impedance analysis by using a Body Composition Analyzer (TANITA Corporation, Japan).
Assessing the change Cardiorespiratory fitness
Time frame: Baseline and 2 months post-intervention
Assessment via using Shuttle run test The 20-m shuttle run (20MSR) test, also called the ''Course Navette'', "PACER", or "Multistage fitness test", is probably the most widely used field test for estimating cardiorespiratory fitness.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- 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.
Heba Yasser, Demonstrator principal investigator
Horus University in Egypt
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 and Low-intensity Continuous Training in people with Overweight and Overweight and Obesity, run by Horus University at 1 site in Egypt.
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 6 inclusion and 7 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 21 Jun 2021. 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 Egypt. 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 Heba Yasser, Demonstrator (+201065015529, hyasser@horus.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change in body Weight (time frame: Baseline and 2 months post-intervention). The study lists 4 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 21 Jun 2021.