Calisthenics Versus High-intensity Interval Exercises on Health-related Outcomes in Patients With Non-alcoholic Fatty Liver
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Liver ultrasound parameters
研究概览
简要总结
According to sample size calculation and after achieving the inclusion criteria, sixty patients with non-alcoholic fatty liver (NAFL) of both genders will be enrolled in this study and their ages will be ranged from30s-40s; they will be selected from internal medicine-outpatient clinics, Cairo University Hospitals; they will participate in the study for 8 weeks, and randomly be assigned into two equal groups in number.
Group (A) (n =30) will receive calisthenics exercise three times /week for eight weeks, group (B) (n =30) will receive HIIT for three times /week for eight weeks and all patients in both groups will receive their prescribed medication (Statin 5mg ).
详细描述
A) Evaluation equipment:
All patients will be evaluated before and after treatment protocol.
- Body composition analyzer (in body 230):- It will be used for estimating body composition, to measure the percentage of the body free fat mass, lean body mass and body mass index (BMI).
Fig (1) Body composition analyzer (in body 230) 2. Mercury and digital sphygmomanometer and stethoscope: it will be used to measure blood pressure. (Niscomed PW-216) 3. Pulse oximeter: It will be used to monitor heart rate and oxygen saturation continuously during exercise (SantaMedical Generation 2 Fingertip).
Fig (2) Pulse oximeter 4. Bruce protocol:-to assess functional capacity (Vo2) max and intensity of exercise. 5. Tape measurement: - to assess waist circumference, waist / hip ratio. 6. Clini-chem 2 analyzer: - to analyze blood lipid profile and liver enzymes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sixty patients with non-alcoholic fatty liver disease (NAFLD) of both genders.
- •Patients with mild non-alcoholic fatty liver disease (NAFLD) according to ultrasonography fatty liver indicator (US-FLI) score (2-4).( Chen et al.,2020)
- •Their age will be ranged from 30s-40s.
- •Body mass index (BMI) from 30 to 34.9 kg/m
- •Body free fat mass (FFM) percentage > 25 % for men,> 35 % for women.
- •Lean body mass (LBM) parentage < 76 % for men; < 69% for women.
- •Waist circumference ≥ 102 cm for men, > 88 cm for women.
- •Waist/Hip ratio > 0.9% for men and > 0.8% for women.
- •Elevated liver enzymes (ALT> 55 U/L, AST> 48 UL, GGT>85 U/L, AST/ALT <1 U/L).
- •Patient with dyslipidemia who has one or more from the following blood lipid values (total cholesterol > 200 mg\dl, LDL > 130 mg\dl, TG >150 mg\dl, HDL< 40mg\dl or LDL/HDL ratio > 4).
- •Low levels of physical activity (using the International Physical Activity Questionnaire- Short Version (IPAQ)) ≤ 10 min walking per day.
- •Liver size estimated by ultrasonography more than 5% from the normal liver size without hepatocellular damage.
排除标准
- •The patient will be excluded if he has one of the following:-
- •Unstable cardiovascular problems like arrhythmia and heart failure.
- •Active Hepatitis C virus HCV.
- •Diabetes mellitus (DM).
- •Hypertensive patients (>140/90mmHg).
- •Active Smoker.
- •Chronic chest disease.
- •Patients on medications affecting muscle power as steroids.
- •Auditory and visual problems.
- •Pregnancy & lactation.
- •Clinically significant peripheral vascular disease (ABPI < 80 %).
- •Patients who take beta-blockers.
- •Severe anemia.
- •Patients with chronic renal failure.
- •Musculoskeletal or neurological limitation to physical exercise.
- •Any cognitive impairment that interferes with prescribed exercise procedures.
- •.Participation in regular exercise training of any type in the previous 3 months
结局指标
主要结局
Liver ultrasound parameters
时间窗: up to 8 weeks
Ultrasonography (USG) (Siemens, ACUSON NX3 ELITE, and German):- to measure size of the liver, thickness of fat outside liver, as well as severity of the fat infiltration Ultrasound :-(Siemens, ACUSON NX3 ELITE, and German):- to measure size of the liver, thickness of fat outside liver, as well as severity of the fat infiltration
Blood lipid profile
时间窗: up to 8 weeks
Cholosterol,TAG,HDL,LDLand LDL/HDL ratio
次要结局
- Body composition analyzer(up to 8 weeks)
- Level of exertion and fatigue(up to 8 weeks)
- Waist circumference(WC) and waist hip ratio(WHR)(up to 8 weeks)
- Functional capacity (VO2)Max(up to 8 weeks)
- Physical activity level(up to 8 weeks)
研究者
Fatma Younis Mahmoud Abdel-Salam
Assistant lecturer
Cairo University