ObesityNCT04708873
Effect of High Intensity Aerobic & Resistance Interval Training on Body Composition, Visceral Adiposity and Myocardial Function in Overweight and Obese Adults
A study testing High intensity interval training and Moderate Intensity Continuous Training in people with Obesity, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
The obesity epidemic, predisposing to cardio-metabolic diseases, has increased two-folds over the last decade with a global alarming cost of obesity-associated illnesses, thus representing a grave peril for the survival of public health care systems. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obesity
- What is being tested?
- High intensity interval training and Moderate Intensity Continuous Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Nov 2020to 30 Dec 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals categorized as Overweight (BMI 23.0 to 24.9) and Obese-Class I (BMI 25.0 to 29.9).
- Both males \& females willing to participate in the study.
- Otherwise healthy young adults aged 18-35 and middle-aged adults (36-55 years).
- No participation in an exercise or PA program during the last 6 months prior to the study.
- Participants able to complete 6-minute walk test as sub-maximal evaluation test without provoking sign and symptoms.
Who cannot join
- Any diagnosed neuromuscular, cardiac, renal, lung, liver disease.
- Individuals with implantable electrical devices such as pacemakers.
- Any physical or psychological dysfunction that hinders participation in the study.
- Individuals already participating in any structured program for weight loss including dietary interventions or usage of nutritional supplements.
- Individuals unable to complete 6 minute walk test due to any reason (dyspnea, fatigue, chest pain etc).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University Institute of Rehabilitation Sciences.
Islamabad, Federal, 46000
Zara Khalid, PhD*, +92 333 5415822, zara.khalid@fui.edu.pk
About this study
The obesity epidemic, predisposing to cardio-metabolic diseases, has increased two-folds over the last decade with a global alarming cost of obesity-associated illnesses, thus representing a grave peril for the survival of public health care systems. It is need of the time to develop evidence-based, time-efficient and cost-effective strategies to prevent and manage obesity. This study would compare the effects of 2 types of exercise regimes providing data on their beneficial effects on body composition and myocardial function along with reducing the central adiposity. This study may also be used as a novel intervention strategy for primary prevention of cardiovascular and metabolic diseases by modification of a major risk factor i.e. obesity in Pakistani population, consequently reducing the burden of morbidity and mortality from cardiometabolic diseases.
Read the detailed description
Obesity is one of the major public health issues of this century. Over the last decade, the prevalence of obesity has increased globally, making it an emerging epidemic and threatening the survival of health care systems. Obesity has long been recognized as the major factor predisposing to cardio-metabolic diseases.The positive role of structured exercise for reducing the mortality and morbidity rates of obese and sedentary adults is well established. But exercise engagement is seen to be quite low in obese adults mainly due to lack of time and non-adherence to exercise training programs. Current trends are now focusing towards another type of exercise regime known as high intensity interval training (HIIT), which is composed of repetitive short to long (< 45 sec to 4 min) bouts of high intensity exercise alternating with rest or recovery periods. Resistance training can also stimulate changes in body composition indices as well as maintain the reduced fat mass after training. Thus resistance exercises are recommended as an adjunct for obesity management by reduction in risk factors. Hence, this study is designed to determine the effects of high intensity interval training in combination with resistance exercises verses moderate intensity continuous training on multiple outcome variables including body composition parameters, visceral adiposity, lipid profile and myocardial function in overweight and obese adult population of Pakistan. Afte r obtaining written informed consent from paricipants, they will be screened using 2020 PAR-Q plus and randomly allocated to one of the 2 groups. A self-structured demographic sheet would be employed for recording demographics and required data including the findings of lab investigations. Then participants will be required to undergo all the physical assessment measures such as anthropometric data, 6 minute walk test, lipid profile, body composition analysis and echocardiography. Physical activity levels and QOL would be assessed by filling IPAQ and SF 36 respectively. Exercise training plans would be performed thrice a week on alternate days for a total duration of 10 weeks. All measurements (anthropometric, cardiac, blood and body composition analyses) would be performed at baseline and later after the 10 weeks intervention period. Exercise intensity will be determined by individualized target heart rate zones using Karvonen formula. Strength training intensity will be determined based on 1-RM. Necessary adjustments to speed/grade and resistance will be made over the course of the intervention to ensure that target heart rate zones are achieved at all times. Apart from the exercise programs, a general similar dietary guidance by a nutritionist would also be provided to both of the groups to avoid unhealthy dietary habits.
- Conditions
- Obesity
- Being tested
- High intensity interval training, Moderate Intensity Continuous Training
- 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 trainingOther
4x4 min intervals of high intensity treadmill running (80-95% of HRR, RPE 7-10 on Borg's category ratio scale of perceived exertion) interspersed with active recovery (slow jogging or fast walking at 50-70% HRR). HIIT-Resistance exercises 2 sessions per week, RPE 5 (hard) 6-8 RM, 1-3 sets of as many repetitions as possible in 60 seconds, active recovery 20-60 seconds b/w exercises,
Moderate Intensity Continuous TrainingOther
Moderate intensity continuous Aerobic exercises (Stationary cycling for 15-20 min followed by treadmill walking for 15-20 min) at 55-70% 55-70% of HRR, RPE 3-4 on Borg's category ratio scale of perceived exertion. The session will be preceded by 5-7 minute warm-up \& 7-10 min cool-down.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training Group | Experimental | Participants in this group will initially undergo continuous aerobic training to achieve a baseline fitness level, after which HIIT and resistance training will be employed. Warm-up period will be followed by 4 bouts of 4-minute interval treadmill running and stationary bike cycling at 80-95% of the measured HR reserve, interspersed with active recovery phase at 55-70% HRR. After this resistance exercises will be performed in a circuit fashion for strengthening the upper limbs, lower limbs and trunk. The session will be ended with a 5-7 minute cool-down period Receives: Other: High intensity interval training |
| Moderate Intensity Continuous Training Group | Active comparator | Participants in this group will also initially undergo continuous aerobic training to achieve a baseline fitness level, after which the intensity will be increased to moderate continuous training achieving 55-70% of HRR. Every session will be preceded by appropriate warm-up and end with cool down. Receives: Other: Moderate Intensity Continuous Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Body Fat
Percentage body fat will be measured using Bioelectrical Impedance Analyzer (Inbody 770) and expressed in forms of percentage (%).
Measured: 10 weeks
Visceral fat area
Visceral fat area will be measured using Bioelectrical Impedance Analyzer (Inbody 770) and expressed in form of centimeter square.
Measured: 10 weeks
Secondary outcomes (4)
Left Ventricular Mass
Left Ventricular Mass depicting myocardial function will be assessed via Echocardiography
Measured: 10 weeks
Left Ventricular Ejection Fraction
Left Ventricular Ejection Fraction depicting myocardial function will be assessed via Echocardiography
Measured: 10 weeks
Cholesterol/HDL ratio
Will be analyzed using Lipid Profile blood testing. A higher score represents poor outcome.
Measured: 10 weeks
Fat free mass
Fat free mass will be measured using Bioelectrical Impedance Analyzer (Inbody 770) and will be expressed in kg.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start25 Nov 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
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.
- 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
- Participants will be randomly allocated to Interventional Group A (High intensity aerobic \& resistance interval training) or Interventional Group B/ Control Group (Moderate intesity continuous training) for the whole duration of the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 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
- NCT04708873
- Sponsor's protocol ID
- FUI/CTR/2020/13
- Status last verified
- Jan 2021
- First submitted
- 1 Jan 2021
- Last updated
- 14 Jan 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 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Intensity Aerobic & Resistance Interval Training on Body Composition, Visceral Adiposity and Myocardial Function in Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT04708873
- Acronym / sponsor ID
- FUI/CTR/2020/13
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 14 Jan 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 obesity epidemic, predisposing to cardio-metabolic diseases, has increased two-folds over the last decade with a global alarming cost of obesity-associated illnesses, thus representing a grave peril for the survival of public health care systems. It is need of the time to develop evidence-based, time-efficient and cost-effective strategies to prevent and manage obesity. This study would compare the effects of 2 types of exercise regimes providing data on their beneficial effects on body composition and myocardial function along with reducing the central adiposity. This study may also be used as a novel intervention strategy for primary prevention of cardiovascular and metabolic diseases by modification of a major risk factor i.e. obesity in Pakistani population, consequently reducing the burden of morbidity and mortality from cardiometabolic diseases.
Detailed description
Obesity is one of the major public health issues of this century. Over the last decade, the prevalence of obesity has increased globally, making it an emerging epidemic and threatening the survival of health care systems. Obesity has long been recognized as the major factor predisposing to cardio-metabolic diseases.The positive role of structured exercise for reducing the mortality and morbidity rates of obese and sedentary adults is well established. But exercise engagement is seen to be quite low in obese adults mainly due to lack of time and non-adherence to exercise training programs. Current trends are now focusing towards another type of exercise regime known as high intensity interval training (HIIT), which is composed of repetitive short to long (< 45 sec to 4 min) bouts of high intensity exercise alternating with rest or recovery periods. Resistance training can also stimulate changes in body composition indices as well as maintain the reduced fat mass after training. Thus resistance exercises are recommended as an adjunct for obesity management by reduction in risk factors. Hence, this study is designed to determine the effects of high intensity interval training in combination with resistance exercises verses moderate intensity continuous training on multiple outcome variables including body composition parameters, visceral adiposity, lipid profile and myocardial function in overweight and obese adult population of Pakistan. Afte r obtaining written informed consent from paricipants, they will be screened using 2020 PAR-Q plus and randomly allocated to one of the 2 groups. A self-structured demographic sheet would be employed for recording demographics and required data including the findings of lab investigations. Then participants will be required to undergo all the physical assessment measures such as anthropometric data, 6 minute walk test, lipid profile, body composition analysis and echocardiography. Physical activity levels and QOL would be assessed by filling IPAQ and SF 36 respectively. Exercise training plans would be performed thrice a week on alternate days for a total duration of 10 weeks. All measurements (anthropometric, cardiac, blood and body composition analyses) would be performed at baseline and later after the 10 weeks intervention period. Exercise intensity will be determined by individualized target heart rate zones using Karvonen formula. Strength training intensity will be determined based on 1-RM. Necessary adjustments to speed/grade and resistance will be made over the course of the intervention to ensure that target heart rate zones are achieved at all times. Apart from the exercise programs, a general similar dietary guidance by a nutritionist would also be provided to both of the groups to avoid unhealthy dietary habits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to Interventional Group A (High intensity aerobic \& resistance interval training) or Interventional Group B/ Control Group (Moderate intesity continuous training) for the whole duration of the study.
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training Group | Experimental | Other: High intensity interval trainingParticipants in this group will initially undergo continuous aerobic training to achieve a baseline fitness level, after which HIIT and resistance training will be employed. Warm-up period will be followed by 4 bouts of 4-minute interval treadmill running and stationary bike cycling at 80-95% of the measured HR reserve, interspersed with active recovery phase at 55-70% HRR. After this resistance exercises will be performed in a circuit fashion for strengthening the upper limbs, lower limbs and trunk. The session will be ended with a 5-7 minute cool-down period |
| Moderate Intensity Continuous Training Group | Active comparator | Other: Moderate Intensity Continuous TrainingParticipants in this group will also initially undergo continuous aerobic training to achieve a baseline fitness level, after which the intensity will be increased to moderate continuous training achieving 55-70% of HRR. Every session will be preceded by appropriate warm-up and end with cool down. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals categorized as Overweight (BMI 23.0 to 24.9) and Obese-Class I (BMI 25.0 to 29.9).
- Both males \& females willing to participate in the study.
- Otherwise healthy young adults aged 18-35 and middle-aged adults (36-55 years).
- No participation in an exercise or PA program during the last 6 months prior to the study.
- Participants able to complete 6-minute walk test as sub-maximal evaluation test without provoking sign and symptoms.
Key exclusion criteria (5 listed)
- Any diagnosed neuromuscular, cardiac, renal, lung, liver disease.
- Individuals with implantable electrical devices such as pacemakers.
- Any physical or psychological dysfunction that hinders participation in the study.
- Individuals already participating in any structured program for weight loss including dietary interventions or usage of nutritional supplements.
- Individuals unable to complete 6 minute walk test due to any reason (dyspnea, fatigue, chest pain etc).
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 training4x4 min intervals of high intensity treadmill running (80-95% of HRR, RPE 7-10 on Borg's category ratio scale of perceived exertion) interspersed with active recovery (slow jogging or fast walking at 50-70% HRR). HIIT-Resistance exercises 2 sessions per week, RPE 5 (hard) 6-8 RM, 1-3 sets of as many repetitions as possible in 60 seconds, active recovery 20-60 seconds b/w exercises, | Other | High Intensity Interval Training Group |
| Moderate Intensity Continuous TrainingModerate intensity continuous Aerobic exercises (Stationary cycling for 15-20 min followed by treadmill walking for 15-20 min) at 55-70% 55-70% of HRR, RPE 3-4 on Borg's category ratio scale of perceived exertion. The session will be preceded by 5-7 minute warm-up \& 7-10 min cool-down. | Other | Moderate Intensity Continuous Training Group |
Primary outcome
Percentage Body Fat
Time frame: 10 weeks
Percentage body fat will be measured using Bioelectrical Impedance Analyzer (Inbody 770) and expressed in forms of percentage (%).
Visceral fat area
Time frame: 10 weeks
Visceral fat area will be measured using Bioelectrical Impedance Analyzer (Inbody 770) and expressed in form of centimeter square.
4 secondary outcomes
Left Ventricular Mass
Time frame: 10 weeks
Left Ventricular Ejection Fraction
Time frame: 10 weeks
Cholesterol/HDL ratio
Time frame: 10 weeks
Fat free mass
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 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.
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 Moderate Intensity Continuous Training in people with 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 5 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 14 Jan 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 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?
Contact Zara Khalid, PhD* (+92 333 5415822, zara.khalid@fui.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Body Fat (time frame: 10 weeks). The study lists 2 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 14 Jan 2021.