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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04950062
Other study ID # Manar_MSc
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date June 30, 2021

Study information

Verified date June 2021
Source Horus University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 30, 2021
Est. primary completion date June 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 35 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
High Intensity Interval Training
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.
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.

Locations

Country Name City State
Egypt Outpatient clinic - Faculty of Physical Therapy - Horus University Damietta

Sponsors (1)

Lead Sponsor Collaborator
Horus University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline and 2 months post-intervention
Primary 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). Baseline and 2 months post-intervention
Primary 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 Baseline and 2 months post-intervention
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