Overweight and ObesityNCT06609954
"COMPARATIVE EFFECTS of REDUCED EXERTION HIGH INTENSITY TRAINING (REHIT) VERSUS HIGH INTENSITY INTERVAL TRAINING (HIIT) on ANTHROPOMETRIC MEASURES in OVERWEIGHT and OBESE ADULTS"
A study testing Reduced Exertion High Intensity Training (REHIT) and High Intensity Interval Training (HIIT) in people with Overweight and Obesity, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Obesity is a global health concern associated with an increased risk of cardio-metabolic diseases and reduced overall health. Exercise is a proven modality for managing obesity, with current focus of researches on identifying more time-efficient modes of exercise training. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Reduced Exertion High Intensity Training (REHIT) and High Intensity Interval Training (HIIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jun 2024to 30 Dec 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both male and female adults aged 18-45 years
- Overweight individuals with BMI ≥ 23kg/m²- 24.9kg/m²
- Obese individuals with BMI ≥ 25kg/m²
- Individuals falling in low PA category as per IPAQ Exclusion Criteria
- Individuals with any diagnosed cardiovascular, metabolic or pulmonary disease
- Current neurological or musculoskeletal conditions which limit participation in the study
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- Any active infections
- Those with any contraindication to exercise testing or training.
- Currently following any dietary restriction plans for weight loss
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
About this study
Obesity is a global health concern associated with an increased risk of cardio-metabolic diseases and reduced overall health. Exercise is a proven modality for managing obesity, with current focus of researches on identifying more time-efficient modes of exercise training. REHIT and HIIT have proven benefits but comparative effects of REHIT and HIIT in overweight and obese adults is yet to be determined. Hence the objective of this study is to compare the effects of reduced exertion high intensity training (REHIT) versus high intensity interval training (HIIT) on anthropometric measures (weight, waist circumference, hip circumference, waist-to-hip ratio), CUN-BAE adiposity index and cardiorespiratory fitness in overweight and obese adults.
Read the detailed description
Obesity is a global health concern associated with an increased risk of cardio-metabolic diseases and reduced overall health. Exercise is a proven modality for managing obesity, with current focus of researches on identifying more time-efficient modes of exercise training. REHIT and HIIT have proven benefits but comparative effects of REHIT and HIIT in overweight and obese adults is yet to be determined.The significance of this study is to compare the effects of reduced exertion high intensity training (REHIT) versus high intensity interval training (HIIT) and will also investigate the effectiveness of REHIT as an alternative for overweight and obese individuals who perceive HIIT as too demanding. If found effective, it can also help in providing training protocol for optimizing cardiovascular health in this population, potentially leading to improved outcomes and reduced healthcare burdens. The results of this study will also add data to literature regarding the effects of REHIT and HIIT on anthropometric measures in overweight and obese. Main objective of this study is to compare the effects of reduced exertion high intensity training (REHIT) versus HIIT on anthropometric measures (weight, waist circumference, hip circumference, waist-to-hip ratio), CUN-BAE adiposity index and Cardiorespiratory fitness in overweight and obese individuals. The participants meeting the eligibility criteria will be recruited followed by random allocation to one of the 2 groups, following which they will be required to complete a self-reported demographic form and will be screened using Physical Activity Readiness Questionnaire (PAR-Q). Baseline evaluation will be done using tape measure for anthropometric, assessment of waist circumference and hip circumference, CUN-BAE index for adiposity and Queen's College step test for cardio-respiratory fitness. Experimental group A will perform REHIT while experimental group B will perform HIIT. Participants will also be provided with dietary restriction plan that will be followed during the training protocol. Exercise training would be performed for consecutive 6 weeks, 3 times a week on alternative days for total of 18 sessions.
- Conditions
- Overweight and Obesity
- Being tested
- Reduced Exertion High Intensity Training (REHIT), High Intensity Interval Training (HIIT)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced Exertion High Intensity Training (REHIT)Other
Participant will perform a 5 min warm-up exercises then do cycling or treadmill running for 20 min at 40%-60% of HRR and then will conclude with 5 min cool down exercises. From week 2 to 6 participants will be instructed to perform training sessions on a cycle ergometer. Each session will consist of a 3-minute warm-up period followed by two 20-second all-out sprints interspersed with 3 minutes of slow pedaling for recovery. Total of 18 sessions of REHIT will be performed thrice a week on alternate days by the participants for consecutive 6 weeks.
High Intensity Interval Training (HIIT)Other
Patients in this group will be provided with a caloric restriction plan by a nutritionist that will be followed throughout the training duration. Week 1 will be baseline fitness level and familiarization week. Participant will perform a 5 min warm-up exercises then do cycling or treadmill running for 20 min at 40%-60% of HRR and then will conclude with 5 min cool down exercises. From week 2 to 6 participants will be instructed to perform a warm up of 5 min, then 4 bouts of 4 min of HIIT will be performed at 80%-95% of HRR separated by 3-min active recovery periods of moderate intensity cycling at 60%-70% of the HRR followed by 5 min cool down exercises. Pre and post session vitals will be noted. Total of 18 sessions of either HIIT will be performed thrice a week on alternate days by the participants for consecutive 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Exertion High intensity Training (REHIT) Group | Experimental | Participant will perform a 5 min warm-up exercises then do cycling or treadmill running for 20 min at 40%-60% of HRR and then will conclude with 5 min cool down exercises. From week 2 to 6 participants will be instructed to perform training sessions on a cycle ergometer.A 3-minute cool-down period will conclude each session. Patients in this group will be provided with a caloric restriction plan by a nutritionist that will be followed throughout the training duration. Receives: Other: Reduced Exertion High Intensity Training (REHIT) |
| High Intensity Interval Training (HIIT) | Experimental | Participant will perform a 5 min warm-up exercises then do cycling or treadmill running for 20 min at 40%-60% of HRR and then will conclude with 5 min cool down exercises. From week 2 to 6 participants will be instructed to perform a warm up of 5 min, then 4 bouts of 4 min of HIIT will be performed at 80%-95% of HRR separated by 3-min active recovery periods of moderate intensity cycling at 60%-70% of the HRR followed by 5 min cool down exercises. Patients in this group will be provided with a caloric restriction plan by a nutritionist that will be followed throughout the training duration. Receives: Other: High Intensity Interval Training (HIIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference
Will be measured using a cloth tape measure. Waist circumference will be measured at the level of the smallest circumference above the umbilicus and below the xiphoid appendix.
Measured: 6 weeks
Hip Circumference:
Measure at the widest point of the hips, with feet together
Measured: 6 weeks
Waist-to-hip Ratio:
To determine the waist-to-hip ratio, divide the WC by the HC
Measured: 6 weeks
Cardiorespiratory fitness
Cardiorespiratory Fitness will be assessed via Queens College step test.
Measured: 6 weeks
Adiposity index
Evaluation will be done using CUN-BAE INDEX (Clínica Universidad de Navarra-Body Adiposity Estimator)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start10 Jun 2024
- Primary completion10 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Model description
- This is a randomized controlled trial having two groups. One group(interventional group) will be given Reduced Exertion High Intensity Training (REHIT) and the other group (control group) will be given High intensity Interval Training (HIIT).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609954
- Sponsor's protocol ID
- FUI/CTR/2024/26
- Status last verified
- Aug 2024
- First submitted
- 20 Sep 2024
- Last updated
- 24 Sep 2024
- 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 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "COMPARATIVE EFFECTS of REDUCED EXERTION HIGH INTENSITY TRAINING (REHIT) VERSUS HIGH INTENSITY INTERVAL TRAINING (HIIT) on ANTHROPOMETRIC MEASURES in OVERWEIGHT and OBESE ADULTS"
- ClinicalTrials.gov ID
- NCT06609954
- Acronym / sponsor ID
- FUI/CTR/2024/26
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 24 Sep 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.
Obesity is a global health concern associated with an increased risk of cardio-metabolic diseases and reduced overall health. Exercise is a proven modality for managing obesity, with current focus of researches on identifying more time-efficient modes of exercise training. REHIT and HIIT have proven benefits but comparative effects of REHIT and HIIT in overweight and obese adults is yet to be determined. Hence the objective of this study is to compare the effects of reduced exertion high intensity training (REHIT) versus high intensity interval training (HIIT) on anthropometric measures (weight, waist circumference, hip circumference, waist-to-hip ratio), CUN-BAE adiposity index and cardiorespiratory fitness in overweight and obese adults.
Detailed description
Obesity is a global health concern associated with an increased risk of cardio-metabolic diseases and reduced overall health. Exercise is a proven modality for managing obesity, with current focus of researches on identifying more time-efficient modes of exercise training. REHIT and HIIT have proven benefits but comparative effects of REHIT and HIIT in overweight and obese adults is yet to be determined.The significance of this study is to compare the effects of reduced exertion high intensity training (REHIT) versus high intensity interval training (HIIT) and will also investigate the effectiveness of REHIT as an alternative for overweight and obese individuals who perceive HIIT as too demanding. If found effective, it can also help in providing training protocol for optimizing cardiovascular health in this population, potentially leading to improved outcomes and reduced healthcare burdens. The results of this study will also add data to literature regarding the effects of REHIT and HIIT on anthropometric measures in overweight and obese. Main objective of this study is to compare the effects of reduced exertion high intensity training (REHIT) versus HIIT on anthropometric measures (weight, waist circumference, hip circumference, waist-to-hip ratio), CUN-BAE adiposity index and Cardiorespiratory fitness in overweight and obese individuals. The participants meeting the eligibility criteria will be recruited followed by random allocation to one of the 2 groups, following which they will be required to complete a self-reported demographic form and will be screened using Physical Activity Readiness Questionnaire (PAR-Q). Baseline evaluation will be done using tape measure for anthropometric, assessment of waist circumference and hip circumference, CUN-BAE index for adiposity and Queen's College step test for cardio-respiratory fitness. Experimental group A will perform REHIT while experimental group B will perform HIIT. Participants will also be provided with dietary restriction plan that will be followed during the training protocol. Exercise training would be performed for consecutive 6 weeks, 3 times a week on alternative days for total of 18 sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial having two groups. One group(interventional group) will be given Reduced Exertion High Intensity Training (REHIT) and the other group (control group) will be given High intensity Interval Training (HIIT).
| Arm | Type | Receives |
|---|---|---|
| Reduced Exertion High intensity Training (REHIT) Group | Experimental | Other: Reduced Exertion High Intensity Training (REHIT)Participant will perform a 5 min warm-up exercises then do cycling or treadmill running for 20 min at 40%-60% of HRR and then will conclude with 5 min cool down exercises. From week 2 to 6 participants will be instructed to perform training sessions on a cycle ergometer.A 3-minute cool-down period will conclude each session. Patients in this group will be provided with a caloric restriction plan by a nutritionist that will be followed throughout the training duration. |
| High Intensity Interval Training (HIIT) | Experimental | Other: High Intensity Interval Training (HIIT)Participant will perform a 5 min warm-up exercises then do cycling or treadmill running for 20 min at 40%-60% of HRR and then will conclude with 5 min cool down exercises. From week 2 to 6 participants will be instructed to perform a warm up of 5 min, then 4 bouts of 4 min of HIIT will be performed at 80%-95% of HRR separated by 3-min active recovery periods of moderate intensity cycling at 60%-70% of the HRR followed by 5 min cool down exercises. Patients in this group will be provided with a caloric restriction plan by a nutritionist that will be followed throughout the training duration. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Both male and female adults aged 18-45 years
- Overweight individuals with BMI ≥ 23kg/m²- 24.9kg/m²
- Obese individuals with BMI ≥ 25kg/m²
- Individuals falling in low PA category as per IPAQ Exclusion Criteria
- Individuals with any diagnosed cardiovascular, metabolic or pulmonary disease
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Reduced Exertion High Intensity Training (REHIT)Participant will perform a 5 min warm-up exercises then do cycling or treadmill running for 20 min at 40%-60% of HRR and then will conclude with 5 min cool down exercises. From week 2 to 6 participants will be instructed to perform training sessions on a cycle ergometer. Each session will consist of a 3-minute warm-up period followed by two 20-second all-out sprints interspersed with 3 minutes of slow pedaling for recovery. Total of 18 sessions of REHIT will be performed thrice a week on alternate days by the participants for consecutive 6 weeks. | Other | Reduced Exertion High intensity Training (REHIT) Group |
| High Intensity Interval Training (HIIT)Patients in this group will be provided with a caloric restriction plan by a nutritionist that will be followed throughout the training duration. Week 1 will be baseline fitness level and familiarization week. Participant will perform a 5 min warm-up exercises then do cycling or treadmill running for 20 min at 40%-60% of HRR and then will conclude with 5 min cool down exercises. From week 2 to 6 participants will be instructed to perform a warm up of 5 min, then 4 bouts of 4 min of HIIT will be performed at 80%-95% of HRR separated by 3-min active recovery periods of moderate intensity cycling at 60%-70% of the HRR followed by 5 min cool down exercises. Pre and post session vitals will be noted. Total of 18 sessions of either HIIT will be performed thrice a week on alternate days by the participants for consecutive 6 weeks. | Other | High Intensity Interval Training (HIIT) |
Primary outcome
Waist circumference
Time frame: 6 weeks
Will be measured using a cloth tape measure. Waist circumference will be measured at the level of the smallest circumference above the umbilicus and below the xiphoid appendix.
Hip Circumference:
Time frame: 6 weeks
Measure at the widest point of the hips, with feet together
Waist-to-hip Ratio:
Time frame: 6 weeks
To determine the waist-to-hip ratio, divide the WC by the HC
Cardiorespiratory fitness
Time frame: 6 weeks
Cardiorespiratory Fitness will be assessed via Queens College step test.
Adiposity index
Time frame: 6 weeks
Evaluation will be done using CUN-BAE INDEX (Clínica Universidad de Navarra-Body Adiposity Estimator)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced Exertion High Intensity Training (REHIT) and High Intensity Interval Training (HIIT) in people with Overweight and Obesity, run by Foundation University Islamabad at 1 site in Pakistan.
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 9 inclusion and 0 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 24 Sep 2024. 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 Pakistan. 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?
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?
Waist circumference (time frame: 6 weeks). The study lists 5 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 24 Sep 2024.