NCT06803108

Brief Summary

exercise is very important maneuver in the control of elevated liver enzymes in complaint of fatty liver .. the exercise forma are many.. from these exercises, pyramidal training or continues aerobic one.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

August 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

January 27, 2025

Last Update Submit

January 27, 2025

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

  • alanine transamianse

    it is a liver enzyme

    it will be measured after 12 weeks

Secondary Outcomes (7)

  • aspartate transaminase

    it will be measured after 12 weeks

  • alkaline phosphatase

    it will be measured after 12 weeks

  • Gamma-glutamyl transferase

    it will be measured after 12 weeks

  • triglycerides

    it will be measured after 12 weeks

  • high density lipoprotein

    it will be measured after 12 weeks

  • +2 more secondary outcomes

Study Arms (2)

group number 1

EXPERIMENTAL

this group of this study will be fatty liver subjects (19 subjects in this group). . In this group, a pyramidal training will be adopted for nearly 60 minutes (nearly two rounds of 21 minutes of running on electronic treadmill will be separated with 10 minutes of rest between the two rounds. Also, warming (4 minutes before start of pyrimidal trianing) and cooling (4 minutes after pyramidal training) will be done through gentle stretching exercises/activities. the form of exercise will be done three times per week. the total study time will be 12 weeks. to be mentioned , this group will follow low calorie diet

Behavioral: pyramidal activity program

group number 2

EXPERIMENTAL

this group of this study will be fatty liver subjects (19 subjects). aerobic training on electronic treadmill will be adopted for 60 minutes in this group with moderate intensity. this form of exercise will be done three times per week. the total study time will be 12 weeks. to be mentioned , this group will follow low clorie diet

Behavioral: aerobic activity program

Interventions

pyramidal activity programBEHAVIORAL

the participating subjects of this group of this study will be fatty liver subjects (19 subjects in this group). aerobic training on electronic treadmill will be adopted for 60 minutes in one group. In this group, a pyramidal training will be adopted for nearly 60 minutes (nearly two rounds of 21 minutes of running on electronic treadmill will be separated with 10 minutes of rest between the two rounds. Also, warming (4 minutes before start of pyrimidal trianing) and cooling (4 minutes after pyramidal training) will be done through gentle stretching exercises/activities. this form form of exercise will be done three times per week. the total study time will be 12 weeks. to be mentioned, the this group will follow low clorie diet

group number 1
aerobic activity programBEHAVIORAL

the participating subjects of the this group of this study will be fatty liver subjects (19 subjects in this group). aerobic training on electronic treadmill will be adopted for 60 minutes in this group with moderate intensity. the form of exercise will be done three times per week. the total study time will be 12 weeks. to be mentioned , this group will follow low clorie diet

group number 2

Eligibility Criteria

Age37 Years - 51 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • fatty liver patients
  • obese patients
  • all patients will class one obesity

You may not qualify if:

  • cardiovascular complaint
  • metabolic complaints
  • othopedic pains in lower limbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Unoversity

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Ali MA Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, lecturer

CONTACT

01005154209ali.mohamed@pt.cu.edu.eg

ramy draz, lecturer

CONTACT

01111534173dr.ramy.salama@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

January 27, 2025

First Posted

January 31, 2025

Study Start

August 1, 2024

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

January 31, 2025

Record last verified: 2025-01

Locations

EG(1)