Leptin and Liver Enzymes Responses to Aerobic Training in Hepatitis c Patients

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04550273

Collaborator

(none)

Enrollment

Location

Arms

12.7

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Exercise is one of the most vital components of health maintenance. Exercising regularly maintains the cardiovascular system health, promotes the health of liver, and declines the risks of complications induced by CHCV. Since overweight is the main risk factor for IR and type 2 DM which may speed the liver disease progression among HCV patients, exercise is very important for maintenance and loss of weight. Further, exercise can relieve the side effects of medications of HCV, improve immunity, promote a sense of well-being, reduce levels of chronic fatigue, improve blood oxygen levels and increase the endorphins excretion which makes the patients fully energized (Elgendi, Shebl A, Sliem M, and Gary FA, 2018).

Studies on exercise effect in patients with CHCV are quite scarce (de Sousa Fernandes et al., 2019). Decreased leptin levels by exercise positively modulate insulin signaling and inhibit pathology progression (Anaruma et al., 2019). Since studies investigated physical activity effect on regulating HCV related leptin levels are very little, the present study aimed to explore the response of serum leptin and liver enzymes to aerobic exercise in nondiabetic overweight men with CHCV.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Behavioral: aerobic treadmill exercise	N/A

Detailed Description

The study group (n=20) received three sessions of aerobic walking exercise per week for 3 months. Every session was done on an electronic treadmill with no inclination started with 5 minutes warm-up then 30 minutes of moderate-intensity aerobic training with 60-75% of target heart rate then followed or ended by 5 minutes cool down. The control group (n=20) will receive no training.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

The Effect of Aerobic Exercise on Liver Enzymes in Overweight Prediabetic Patients With Hepatitis c

Actual Study Start Date :

Feb 9, 2020

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: study group The study group (n=20) will receive three sessions of aerobic walking exercise per week for 3 months in addition to the traditional medical treatment	Behavioral: aerobic treadmill exercise The study group (n=20) received three sessions of aerobic exercise per week for 3 months. Every session was done on an electronic treadmill with no inclination started with 5 minutes warm-up then 30 minutes of moderate-intensity aerobic training with 60-75% of target heart rate then followed or ended by 5 minutes cool down.
No Intervention: control group The control group (n=20) will receive no training

Arm

Intervention/Treatment

Experimental: study group

The study group (n=20) will receive three sessions of aerobic walking exercise per week for 3 months in addition to the traditional medical treatment

Behavioral: aerobic treadmill exercise

The study group (n=20) received three sessions of aerobic exercise per week for 3 months. Every session was done on an electronic treadmill with no inclination started with 5 minutes warm-up then 30 minutes of moderate-intensity aerobic training with 60-75% of target heart rate then followed or ended by 5 minutes cool down.

No Intervention: control group

The control group (n=20) will receive no training

Outcome Measures

Primary Outcome Measures

Leptin [It will be after 12-week training]
It will be measured in plasma
Liver enzymes [liver enzymes will be after 12-week training]
Serum alanine and aspartate transaminases (AST), (ALT) will be measured in plasma

Secondary Outcome Measures

weight [It will be after 12-week training]
With an empty bladder and stomach, weight will be measured for every participant
Waist circumference (WC) [It will be after 12-week training]
WC will be measured with an inelastic tape at the umbilicus level
fasting blood glucose (FBG) [It will be after 12-week training]
FBG will be measured by On Call ® Plus Acon, REF G113- 214, made in China

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Men with hepatitis C patients at least from 6 months
BMI ranged ≥ 25 to < 30 kg/m2.
fasting blood glucose level (FBG) < 100 mg/dl.
waist circumference < 102 cm.

Exclusion Criteria:

Besides the excluded individuals who participated in any form of physical training in the last 6 months, excluded patients by a physician will be patients with acute or other hepatitis types, cirrhotic or hepatocellular carcinoma, renal or respiratory problems, cardiovascular and neurologic diseases, and hypertension

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Physical Therapy Cairo University	Giza	Dokki	Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Ali Ismail, lecturer, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ali Mohamed Ali ismail, lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University, Cairo University

ClinicalTrials.gov Identifier:

NCT04550273

Other Study ID Numbers: