High Intensity Interval Training Versus Intermittent Fasting on Functional Capacity Among Overweight Subjects
Effect of High Intensity Interval Training Versus Intermittent Fasting 16/8 Protocol on Functional Capacity Among Overweight Subjects
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2021
CompletedFirst Submitted
Initial submission to the registry
June 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedFirst Posted
Study publicly available on registry
July 6, 2021
CompletedJuly 6, 2021
June 1, 2021
4 months
June 12, 2021
June 30, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (2)
High intensity interval training
EXPERIMENTALGroup A included 30 subjects who will participate in high intensity interval training on a treadmill for 12 weeks, 3 times/week.
Intermittent fasting
ACTIVE COMPARATORGroup B that included 30 subjects will participate in intermittent fasting for 12 weeks, 3 times/week.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Horus Universitylead
Study Sites (1)
Outpatient clinic - Faculty of Physical Therapy - Horus University
Damietta, 34518, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manar Elbaz, Demonstrator
Horus University in Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 12, 2021
First Posted
July 6, 2021
Study Start
February 1, 2021
Primary Completion
June 15, 2021
Study Completion
June 30, 2021
Last Updated
July 6, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share