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Effect of High Intensity Aerobic & Resistance Interval Training on Body Composition, Visceral Adiposity and Myocardial Function in Overweight and Obese Adults

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
High intensity interval training
Moderate Intensity Continuous Training
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Individuals categorized as Overweight (BMI 23.0 to 24.9) and Obese-Class I (BMI 25.0 to 29.9).
  2. Both males & females willing to participate in the study.
  3. Otherwise healthy young adults aged 18-35 and middle-aged adults (36-55 years).
  4. No participation in an exercise or PA program during the last 6 months prior to the study.
  5. Participants able to complete 6-minute walk test as sub-maximal evaluation test without provoking sign and symptoms.

Exclusion Criteria:

  1. Any diagnosed neuromuscular, cardiac, renal, lung, liver disease.
  2. Individuals with implantable electrical devices such as pacemakers.
  3. Any physical or psychological dysfunction that hinders participation in the study.
  4. Individuals already participating in any structured program for weight loss including dietary interventions or usage of nutritional supplements.
  5. Individuals unable to complete 6 minute walk test due to any reason (dyspnea, fatigue, chest pain etc).

Sites / Locations

  • Foundation University Institute of Rehabilitation Sciences.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Intensity Interval Training Group

Moderate Intensity Continuous Training Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Percentage Body Fat
Percentage body fat will be measured using Bioelectrical Impedance Analyzer (Inbody 770) and expressed in forms of percentage (%).
Visceral fat area
Visceral fat area will be measured using Bioelectrical Impedance Analyzer (Inbody 770) and expressed in form of centimeter square.

Secondary Outcome Measures

Left Ventricular Mass
Left Ventricular Mass depicting myocardial function will be assessed via Echocardiography
Left Ventricular Ejection Fraction
Left Ventricular Ejection Fraction depicting myocardial function will be assessed via Echocardiography
Cholesterol/HDL ratio
Will be analyzed using Lipid Profile blood testing. A higher score represents poor outcome.
Fat free mass
Fat free mass will be measured using Bioelectrical Impedance Analyzer (Inbody 770) and will be expressed in kg.

Full Information

First Posted
January 1, 2021
Last Updated
January 12, 2021
Sponsor
Foundation University Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT04708873
Brief Title
Effect of High Intensity Aerobic & Resistance Interval Training on Body Composition, Visceral Adiposity and Myocardial Function in Overweight and Obese Adults
Official Title
Effect of High Intensity Aerobic & Resistance Interval Training on Body Composition, Visceral Adiposity and Myocardial Function in Overweight and Obese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
It will be a single blinded study. Only the participants will be masked.
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Interval Training Group
Arm Type
Experimental
Arm Description
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
Arm Title
Moderate Intensity Continuous Training Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
High intensity interval training
Intervention Description
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,
Intervention Type
Other
Intervention Name(s)
Moderate Intensity Continuous Training
Intervention Description
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 &amp; 7-10 min cool-down.
Primary Outcome Measure Information:
Title
Percentage Body Fat
Description
Percentage body fat will be measured using Bioelectrical Impedance Analyzer (Inbody 770) and expressed in forms of percentage (%).
Time Frame
10 weeks
Title
Visceral fat area
Description
Visceral fat area will be measured using Bioelectrical Impedance Analyzer (Inbody 770) and expressed in form of centimeter square.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Left Ventricular Mass
Description
Left Ventricular Mass depicting myocardial function will be assessed via Echocardiography
Time Frame
10 weeks
Title
Left Ventricular Ejection Fraction
Description
Left Ventricular Ejection Fraction depicting myocardial function will be assessed via Echocardiography
Time Frame
10 weeks
Title
Cholesterol/HDL ratio
Description
Will be analyzed using Lipid Profile blood testing. A higher score represents poor outcome.
Time Frame
10 weeks
Title
Fat free mass
Description
Fat free mass will be measured using Bioelectrical Impedance Analyzer (Inbody 770) and will be expressed in kg.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zara Khalid, PhD*
Phone
+92 333 5415822
Email
zara.khalid@fui.edu.pk
Facility Information:
Facility Name
Foundation University Institute of Rehabilitation Sciences.
City
Islamabad
State/Province
Federal
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zara Khalid, PhD*
Phone
+92 333 5415822
Email
zara.khalid@fui.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of High Intensity Aerobic & Resistance Interval Training on Body Composition, Visceral Adiposity and Myocardial Function in Overweight and Obese Adults

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