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出境医 / 临床实验 / High Intensity Interval Training Versus Low-intensity Continuous Training on Physical Fitness Among Overweight Adult

High Intensity Interval Training Versus Low-intensity Continuous Training on Physical Fitness Among Overweight Adult

Study Description
Brief Summary:
The purpose of the study is to compare the effect of high intensity interval training and low intensity training on physical fitness among adult overweight.

Condition or disease Intervention/treatment Phase
Overweight Overweight and Obesity Other: High-intensity Interval Training Other: Low-intensity Continuous Training Not Applicable

Detailed Description:

Excess body weight has been shown to negatively influence musculoskeletal health and may limit physical function. Thus, there is a need for effective interventions to reduce body weight in those individuals who may already be overweight or obese. Physical activity can be an important component of lifestyle interventions for weight loss. Thus, it is important for clinicians, health care providers, and health-fitness professionals to recognize the influence of physical activity on body weight and to understand recommendations that can affect physical activity behavior. Several studies reported that HIIT can improve cardiorespiratory fitness (increase vo2 max) in adults with varied body weight and health status.

High intensity interval training induced improvements in insulin sensitivity, blood pressure, and body composition more consistently occur in adults with overweight, with or without high risk of cardiovascular disease and diabetes especially if these participate in prolonged exercise program up to 12 or more weeks.

Low intensity exercise has been shown to have a range of physiological and biochemical effects during a subsequent bout of exercise Low intensity exercise would result in muscle acetyl group accumulation and thereby would accelerate mitochondrial ATP production (and reduce ATP production from nonoxidative routes) during a subsequent bout of moderate intensity exercise. In accordance with these changes, we also hypothesized that the vo2 on-kinetics during moderate intensity exercise would be accelerated when preceded by low intensity exercise .

The significant behind this study came up with the importance to declare the effect of high intensity interval training on improving physical fitness and body composition which be more suitable for overweight active people that don't have time to practice prolonged exercise during the week and this study also will investigates the effect of low intensity exercise on physical fitness and body composition to declare where is going to be beneficial for overweight sedentary subjects and compare it is effect with pervious.

This study will be designed to provide a guideline about the effect of high intensity interval training& low intensity training exercise on physical fitness in the overweight adult patient.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of High Intensity Interval Training Versus Low Intensity Continuous Training on Physical Fitness Among Overweight Adult
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : July 15, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: High-intensity Interval Training
Group 2: the included 15 subjects will participate in High intensity Interval training exercise running on treadmill for 12 weeks, 3 times / week.
Other: High-intensity Interval Training

Consisting of the following program:

  • Warming up period for 10 minutes at 60-70% of HR max.
  • Training phase 4x4 min intervals at 85-90% of HRmax with a 3 min active recovery at 70% of HRmax between each interval.
  • Duration of HIIT 4 minute
  • Number of interval per session 4
  • Duration of rest interval 3 minute 3-10 min cool-down period, giving a total of 60 min.

Active Comparator: Low-intensity Continuous Training
Group 1: the included 15 subjects will participate in low intensity continuous exercise on treadmill for 12 weeks, 3 times / week
Other: Low-intensity Continuous Training

Consisting of the following program:

  • Warming up period for 10 minutes.
  • Training phase for 60-minute walking on a treadmill at intensity 40-50% HRR (1- 6) weeks then 60-70% HRR (7-12) weeks.
  • cooling down period for 10 minutes.

Outcome Measures
Primary Outcome Measures :
  1. Assessing the change in body Weight [ Time Frame: Baseline and 2 months post-intervention ]
    Assessment via using body weight scale with height (m) scale to be able to calculate body mass index (Kg) to all subjects before starting the study BMI= Weight (KG) /Height2 (M2)

  2. Assessing the change in Waist hip ratio [ Time Frame: Baseline and 2 months post-intervention ]
    Assessment via using was measured to the nearest 0.1 cm by using a flexible steel tape at the level of umbilicus, and hip circumference (HC) was measured at the widest level over the greater trochanters.

  3. Assessing the change in body fat [ Time Frame: Baseline and 2 months post-intervention ]
    Assessment through bioelectrical impedance analysis by using a Body Composition Analyzer (TANITA Corporation, Japan).

  4. Assessing the change Cardiorespiratory fitness [ Time Frame: Baseline and 2 months post-intervention ]
    Assessment via using Shuttle run test The 20-m shuttle run (20MSR) test, also called the ''Course Navette'', "PACER", or "Multistage fitness test", is probably the most widely used field test for estimating cardiorespiratory fitness.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Body mass index (BMI) will be ≥ 25 -29.9 kg/m².
  2. Age will be ranging from 20 to 30 years.
  3. Waist circumference >88cm2 in men and >102cm2 in women.
  4. Content of body fat will be assisted by electrical bioimpedence≥33%.
  5. Stable body weight in the month prior to the trial.
  6. Follow instructions for healthy life style.

Exclusion Criteria:

  1. Patients with musculoskeletal deformities and disorders.
  2. Patients with other neuromuscular disorders.
  3. Patients with foot deformities and ulcers.
  4. Patients with lower limb operations.
  5. Smoking cigarettes, thyroid diseases.
  6. History of coronary artery disease Asthma, chronic obstructive pulmonary diseases.
  7. poorly controlled hypertension (mean systolic blood pressure (SBP) > 140 mm Hg and/or mean diastolic blood pressure (DBP) > 90 mm Hg) during the month prior to the trial.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Heba Yasser, Demonstrator +201065015529 hyasser@horus.edu.eg

Locations
Layout table for location information
Egypt
Outpatient clinic - Faculty of Physical Therapy - Horus University Recruiting
Damieta, Egypt, 34518
Contact: Heba Yasser, Demonstrator    +201065015529    hyasser@horus.edu.eg   
Sponsors and Collaborators
Horus University
Investigators
Layout table for investigator information
Principal Investigator: Heba Yasser, Demonstrator Horus University in Egypt
Tracking Information
First Submitted Date  ICMJE June 13, 2021
First Posted Date  ICMJE June 21, 2021
Last Update Posted Date June 21, 2021
Actual Study Start Date  ICMJE April 1, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2021)
  • Assessing the change in body Weight [ Time Frame: Baseline and 2 months post-intervention ]
    Assessment via using body weight scale with height (m) scale to be able to calculate body mass index (Kg) to all subjects before starting the study BMI= Weight (KG) /Height2 (M2)
  • Assessing the change in Waist hip ratio [ Time Frame: Baseline and 2 months post-intervention ]
    Assessment via using was measured to the nearest 0.1 cm by using a flexible steel tape at the level of umbilicus, and hip circumference (HC) was measured at the widest level over the greater trochanters.
  • Assessing the change in body fat [ Time Frame: Baseline and 2 months post-intervention ]
    Assessment through bioelectrical impedance analysis by using a Body Composition Analyzer (TANITA Corporation, Japan).
  • Assessing the change Cardiorespiratory fitness [ Time Frame: Baseline and 2 months post-intervention ]
    Assessment via using Shuttle run test The 20-m shuttle run (20MSR) test, also called the ''Course Navette'', "PACER", or "Multistage fitness test", is probably the most widely used field test for estimating cardiorespiratory fitness.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Intensity Interval Training Versus Low-intensity Continuous Training on Physical Fitness Among Overweight Adult
Official Title  ICMJE Effect of High Intensity Interval Training Versus Low Intensity Continuous Training on Physical Fitness Among Overweight Adult
Brief Summary The purpose of the study is to compare the effect of high intensity interval training and low intensity training on physical fitness among adult overweight.
Detailed Description

Excess body weight has been shown to negatively influence musculoskeletal health and may limit physical function. Thus, there is a need for effective interventions to reduce body weight in those individuals who may already be overweight or obese. Physical activity can be an important component of lifestyle interventions for weight loss. Thus, it is important for clinicians, health care providers, and health-fitness professionals to recognize the influence of physical activity on body weight and to understand recommendations that can affect physical activity behavior. Several studies reported that HIIT can improve cardiorespiratory fitness (increase vo2 max) in adults with varied body weight and health status.

High intensity interval training induced improvements in insulin sensitivity, blood pressure, and body composition more consistently occur in adults with overweight, with or without high risk of cardiovascular disease and diabetes especially if these participate in prolonged exercise program up to 12 or more weeks.

Low intensity exercise has been shown to have a range of physiological and biochemical effects during a subsequent bout of exercise Low intensity exercise would result in muscle acetyl group accumulation and thereby would accelerate mitochondrial ATP production (and reduce ATP production from nonoxidative routes) during a subsequent bout of moderate intensity exercise. In accordance with these changes, we also hypothesized that the vo2 on-kinetics during moderate intensity exercise would be accelerated when preceded by low intensity exercise .

The significant behind this study came up with the importance to declare the effect of high intensity interval training on improving physical fitness and body composition which be more suitable for overweight active people that don't have time to practice prolonged exercise during the week and this study also will investigates the effect of low intensity exercise on physical fitness and body composition to declare where is going to be beneficial for overweight sedentary subjects and compare it is effect with pervious.

This study will be designed to provide a guideline about the effect of high intensity interval training& low intensity training exercise on physical fitness in the overweight adult patient.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight
  • Overweight and Obesity
Intervention  ICMJE
  • Other: High-intensity Interval Training

    Consisting of the following program:

    • Warming up period for 10 minutes at 60-70% of HR max.
    • Training phase 4x4 min intervals at 85-90% of HRmax with a 3 min active recovery at 70% of HRmax between each interval.
    • Duration of HIIT 4 minute
    • Number of interval per session 4
    • Duration of rest interval 3 minute 3-10 min cool-down period, giving a total of 60 min.
  • Other: Low-intensity Continuous Training

    Consisting of the following program:

    • Warming up period for 10 minutes.
    • Training phase for 60-minute walking on a treadmill at intensity 40-50% HRR (1- 6) weeks then 60-70% HRR (7-12) weeks.
    • cooling down period for 10 minutes.
Study Arms  ICMJE
  • Experimental: High-intensity Interval Training
    Group 2: the included 15 subjects will participate in High intensity Interval training exercise running on treadmill for 12 weeks, 3 times / week.
    Intervention: Other: High-intensity Interval Training
  • Active Comparator: Low-intensity Continuous Training
    Group 1: the included 15 subjects will participate in low intensity continuous exercise on treadmill for 12 weeks, 3 times / week
    Intervention: Other: Low-intensity Continuous Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2021)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Body mass index (BMI) will be ≥ 25 -29.9 kg/m².
  2. Age will be ranging from 20 to 30 years.
  3. Waist circumference >88cm2 in men and >102cm2 in women.
  4. Content of body fat will be assisted by electrical bioimpedence≥33%.
  5. Stable body weight in the month prior to the trial.
  6. Follow instructions for healthy life style.

Exclusion Criteria:

  1. Patients with musculoskeletal deformities and disorders.
  2. Patients with other neuromuscular disorders.
  3. Patients with foot deformities and ulcers.
  4. Patients with lower limb operations.
  5. Smoking cigarettes, thyroid diseases.
  6. History of coronary artery disease Asthma, chronic obstructive pulmonary diseases.
  7. poorly controlled hypertension (mean systolic blood pressure (SBP) > 140 mm Hg and/or mean diastolic blood pressure (DBP) > 90 mm Hg) during the month prior to the trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Heba Yasser, Demonstrator +201065015529 hyasser@horus.edu.eg
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04932174
Other Study ID Numbers  ICMJE Hebayasser_MSc
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Heba Yasser, Horus University
Study Sponsor  ICMJE Horus University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Heba Yasser, Demonstrator Horus University in Egypt
PRS Account Horus University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP