High Intensity Interval Training Versus Intermittent Fasting on Functional Capacity Among Overweight Subjects

NCT ID: NCT04950062

Last Updated: 2021-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-06-30

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.

Conditions

Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High intensity interval training

Group A included 30 subjects who will participate in high intensity interval training on a treadmill for 12 weeks, 3 times/week.

Group Type: EXPERIMENTAL

High Intensity Interval Training

Intervention Type: OTHER

1. Warming up period for 5 min at an intensity corresponding to 65-75% of heart rate maximum (HRmax).

2. 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.

3. 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.

Intermittent fasting

Group B that included 30 subjects will participate in intermittent fasting for 12 weeks, 3 times/week.

Group Type: ACTIVE_COMPARATOR

Intermittent Fasting 16/8 Protocol

Intervention Type: OTHER

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.

Interventions

High Intensity Interval Training

1. Warming up period for 5 min at an intensity corresponding to 65-75% of heart rate maximum (HRmax).

2. 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.

3. 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

Intermittent Fasting 16/8 Protocol

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects have to meet all the following criteria in order to participate in the study:

1. Overweight subjects with age from 25 to 35 years.

2. Body mass index will be range from 25 to 29.9 kg/m2.

3. Waist circumference ≥ 80 cm2.

4. 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:

1. Musculoskeletal, cardiovascular disorders.

2. Asthma, chronic obstructive pulmonary diseases.

3. Any systemic disease or condition that might reduce adherence or tolerance to exercise or fasting.

4. History of stroke.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Horus University

OTHER

Sponsor Role: lead

Responsible Party

Manar Elbaz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manar Elbaz, Demonstrator

Role: PRINCIPAL_INVESTIGATOR

Horus University in Egypt

Locations

Outpatient clinic - Faculty of Physical Therapy - Horus University

Damietta, , Egypt

Countries

Egypt

Other Identifiers

Manar_MSc

Identifier Type: -

Identifier Source: org_study_id