High Intensity Interval Training Versus Intermittent Fasting on Functional Capacity Among Overweight Subjects
Primary Purpose
Overweight
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High Intensity Interval Training
Intermittent Fasting 16/8 Protocol
Sponsored by

About this trial
This is an interventional treatment trial for Overweight
Eligibility Criteria
Inclusion Criteria:
Subjects have to meet all the following criteria in order to participate in the study:
- Overweight subjects with age from 25 to 35 years.
- Body mass index will be range from 25 to 29.9 kg/m2.
- Waist circumference ≥ 80 cm2.
- A minimum of 70% of exercise program and diet regimen compliance will be required in order to be included.
Exclusion Criteria:
Subjects with the following disorders will be excluded from participating in this study:
- Musculoskeletal, cardiovascular disorders.
- Asthma, chronic obstructive pulmonary diseases.
- Any systemic disease or condition that might reduce adherence or tolerance to exercise or fasting.
- History of stroke.
Sites / Locations
- Outpatient clinic - Faculty of Physical Therapy - Horus University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High intensity interval training
Intermittent fasting
Arm Description
Group A included 30 subjects who will participate in high intensity interval training on a treadmill for 12 weeks, 3 times/week.
Group B that included 30 subjects will participate in intermittent fasting for 12 weeks, 3 times/week.
Outcomes
Primary Outcome Measures
Assessing the change in Vo2max
Assessment via using Standard Bruce protocol will be used to measure (VO2) max. The Bruce protocol for multi stage treadmill testing of maximal exercise will be used. This will begin with stage 1 with walking slowly for three minutes at 2.7 Km/hr at a 10% grade (inclination), speed and grade then increased in every stage of 3 minutes and end at stage 7 or till exhaustion.
Assessing the change in body weight
Assessment via using of body weight scale with height (m) scale to be able to calculate body weight (Kg).
Assessing the change in waist hip circumference
Assessment via using Tape measures It will be used to measure waist and hip circumference and calculate waist hip ratio
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04950062
Brief Title
High Intensity Interval Training Versus Intermittent Fasting on Functional Capacity Among Overweight Subjects
Official Title
Effect of High Intensity Interval Training Versus Intermittent Fasting 16/8 Protocol on Functional Capacity Among Overweight Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Horus University
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 purpose of the study is to compare the effect of high-intensity interval training and intermittent fasting on improving body weight and functional capacity among overweight subjects.
Detailed Description
Exercise improves cardiorespiratory fitness, muscle strength, endurance, body composition, and decreases visceral fat. The, increase in physical activity and modification of eating behaviors are the first line of interventions given because of their low costs and low risks of complications.
Most commonly, the continuous exercise of moderate intensity, that has to be performed several days of the week to get target benefits have been used, on the other hand, different forms of training which aim to reduce time spent exercising by increasing exercise intensity have been considered as an alternative to increasing adherence to the training program which is supported by some researches that may have greater benefits as high intensity interval training improves the vascular function of the muscle capillary density and endothelial nitric oxide synthase(eNOS) levels. But there are some overweight people even some of the young people have restriction to perform exercise programs due to any medical problem that could interfere with exercise.
So, searching for optimal dietary interventions for obesity is still ongoing, but the modification in eating behaviors are hampered by difficulties in coping with a different diet. So, the diet with a fasting component that will be used in this study may be more effective than other complex and restrictive diets as it essentially limits the caloric intake to a specified period without major diet composition changes.
So, the aim of this study is to compare the effect of high-intensity interval training and intermittent fasting on improving body weight and functional capacity among overweight subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High intensity interval training
Arm Type
Experimental
Arm Description
Group A included 30 subjects who will participate in high intensity interval training on a treadmill for 12 weeks, 3 times/week.
Arm Title
Intermittent fasting
Arm Type
Active Comparator
Arm Description
Group B that included 30 subjects will participate in intermittent fasting for 12 weeks, 3 times/week.
Intervention Type
Other
Intervention Name(s)
High Intensity Interval Training
Intervention Description
Warming up period for 5 min at an intensity corresponding to 65-75% of heart rate maximum (HRmax).
Training phase for 30 min divided into four sets of 4-min length each at intensity equals 80-90% of HRmax interspersed by 3 minutes low intensity walking at the level of 65-75% of HRmax.
Cooling down period for 5 min of at 50-60% of the HRmax. All subjects will be trained at the lower intensity limit for the first 2 weeks of the program before increasing the intensity levels toward the upper limit.
Intervention Type
Other
Intervention Name(s)
Intermittent Fasting 16/8 Protocol
Intervention Description
Every subject will be instructed to fast a fixed 16 hours followed by 8 hours of eating every day through the whole study period based on their life and sleeping style. During fasting, zero-calorie coffee, tea and water intake will be permitted. Beverages containing calories were consumed during the feeding hours each day. All subjects will be instructed about their optimum caloric requirement based on their basal metabolic rate that will be calculated in advance to avoid over consumption of food on severe caloric restriction as we like to investigate the effect of this way of fasting on reducing weight and improving functional capacity.
Primary Outcome Measure Information:
Title
Assessing the change in Vo2max
Description
Assessment via using Standard Bruce protocol will be used to measure (VO2) max. The Bruce protocol for multi stage treadmill testing of maximal exercise will be used. This will begin with stage 1 with walking slowly for three minutes at 2.7 Km/hr at a 10% grade (inclination), speed and grade then increased in every stage of 3 minutes and end at stage 7 or till exhaustion.
Time Frame
Baseline and 2 months post-intervention
Title
Assessing the change in body weight
Description
Assessment via using of body weight scale with height (m) scale to be able to calculate body weight (Kg).
Time Frame
Baseline and 2 months post-intervention
Title
Assessing the change in waist hip circumference
Description
Assessment via using Tape measures It will be used to measure waist and hip circumference and calculate waist hip ratio
Time Frame
Baseline and 2 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects have to meet all the following criteria in order to participate in the study:
Overweight subjects with age from 25 to 35 years.
Body mass index will be range from 25 to 29.9 kg/m2.
Waist circumference ≥ 80 cm2.
A minimum of 70% of exercise program and diet regimen compliance will be required in order to be included.
Exclusion Criteria:
Subjects with the following disorders will be excluded from participating in this study:
Musculoskeletal, cardiovascular disorders.
Asthma, chronic obstructive pulmonary diseases.
Any systemic disease or condition that might reduce adherence or tolerance to exercise or fasting.
History of stroke.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manar Elbaz, Demonstrator
Organizational Affiliation
Horus University in Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic - Faculty of Physical Therapy - Horus University
City
Damietta
ZIP/Postal Code
34518
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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High Intensity Interval Training Versus Intermittent Fasting on Functional Capacity Among Overweight Subjects
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