Hybrid Training and Middle Age

• Sponsor: University of Sistan and Baluchestan (Other)
• Overall Status: Completed
• CT.gov ID: NCT05231564
• Collaborator: Niloofar Zareie Mohammad Zadeh (Other)
• Enrollment: 15
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

Modern living and physical inactivity results in many ailments, including obesity, non-alcoholic fatty liver disease (NAFLD), and inflammatory issues.

Though there are a lot of studies on physical training, there is little detail on hybrid training or electrical and voluntary contractions of the musculature. This study investigated the efficiency of hybrid training in biochemistry, ultrasound, and proinflammatory outcomes in middle-aged sedentary and obese women with NAFLD.

Condition or Disease	Intervention/Treatment	Phase
Women's Health; Hybrid Training; Middle Aged; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome	Other: hybrid training	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel AssignmentParallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Study of Hybrid Training on Lipid Profile and Non-alcoholic Fatty Liver Disease in Middle-aged Obese Women
• Actual Study Start Date: Nov 1, 2019
• Actual Primary Completion Date: Dec 2, 2019
• Actual Study Completion Date: Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hybrid training 15 women for hybrid training.	Other: hybrid training; The experimental group trained two to three sessions of 45 to 50 minutes a week with a recovery of 24 to 48 hours between each session to burn 500 kcal. The first three weeks held hybrid training with a metabolic program and the other three weeks held a strength training program.
No Intervention: Healthy lifestyle counseling 15 women for healthy lifestyle counseling

Outcome Measures

Primary Outcome Measures

1. Body Weight [Pre-study]

   in kg

2. Body Mass Index [Pre-study]

   in kg/m-2

3. Aspartate transaminases [Pre-study]

   in u/l

4. Alanine transaminases [Pre-study]

   in u/l

5. Fasting blood sugar [Pre-study]

   in mg/dl

6. Proinflammatory cytokine (interleukin -6) [Pre-study]

   in pg/ml

7. Ultrasonic assessment [Pre-study]

   Grade of liver steatosis

8. WHR [Pre-study]

   Waist-to-hip ratio in cm

9. SBP/DBP [Pre-study]

   Systolic blood pressure/Diastolic blood pressure

10. HDL Cholesterol Plasma [Pre-study]

    in mg/dl

Secondary Outcome Measures

1. Body Weight [six-week]

   in kg

2. Body Mass Index [six-week]

   in kg/m-2

3. Aspartate transaminases [six-week]

   in u/l

4. Alanine transaminases [six-week]

   in u/l

5. Fasting blood sugar [six-week]

   in mg/dl

6. Proinflammatory cytokine (interleukin -6) [six-week]

   in pg/ml

7. Ultrasonic assessment [six-week]

   Grade of liver steatosis

8. WHR [six-week]

   Waist-to-hip ratio in cm

9. SBP/DBP [six-week]

   Systolic blood pressure/Diastolic blood pressure

10. HDL Cholesterol Plasma [six-week]

    in mg/dl

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Sedentary women with one to two exercise sessions or less per month

• BMI equal to or above 30 kg/m-2

• WHR equal or above 0.85 m

• Confirmed NAFLD, with grade 2 and 3

• Systolic blood pressure not less than 130 mm Hg and diastolic blood pressure not less than 85 mm Hg

• Increased AST and ALT

• Mean age 45-65 years

Exclusion Criteria:

• Use of 140 grams or more of ethanol per week

• History of depression in the last 6 months

• History of chronic or acute viral hepatitis

• Drug-related liver disease and chronic liver disease

• History of diabetes

• Uncontrolled hypertension

• Myocardial infarction

• Chronic kidney disease

• Hyperthyroidism or heart failure

• Those who have weight loss programs or medical contraindications for physical training

• Serious arterial hemorrhagic disorders

• Serious neurological diseases

• Advanced atherosclerosis

• Elevated fever

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mohammadreza Rezaeipour (MD, PhD)	Zahedan	Sistan And Baluchestan	Iran, Islamic Republic of	9816745639

Sponsors and Collaborators

• University of Sistan and Baluchestan
• Niloofar Zareie Mohammad Zadeh

Investigators

• Principal Investigator: Mohammadreza Rezaeipour, MD, PhD, University of Sistan and Baluchestan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammadreza Rezaeipour, Asst.Prof.Dr. of sports science, University of Sistan and Baluchestan
• ClinicalTrials.gov Identifier: NCT05231564
• Other Study ID Numbers: no grant
• First Posted: Feb 9, 2022
• Last Update Posted: Feb 28, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome

Study Results

No Results Posted as of Feb 28, 2022