NCT05704608

Brief Summary

The liver plays a central role in energy exchange, protein synthesis as well as the elimination of waste products from the body. The optimal functioning of the liver is essential for athletic performance. It becomes necessary to maintain the enzymes of the liver at an optimal level so that liver cells can be protected from inflammation or damage. This paper investigated the effects of a twelve-week aerobic exercise program on the liver function of adult athletes. A total of thirty (30) healthy male athletes aged 21 to 24 were recruited for this study and kept in two equal groups. The control group was kept under rigorous supervision and did not participate in any special activities. The experiment group was well-versed in their assigned training program and solely performed the experimental procedure for twelve (12) weeks. Evaluation of all patients in both experimental and control groups was carried out before and after the treatment program by measuring the levels of (Alkaline phosphate, AST/SGOT, ALT/SGPT, Bilirubin Total/indirect/direct, Albumin, Globulin, and Total protein) respectively using standard methods by collecting blood samples, 5 mls each of baseline into lithium heparin containers for estimation of above biochemical parameters at the pathology laboratory accredited by National Accreditation Board for Testing and Calibration Laboratories accredited (NABL, India).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

January 19, 2023

Last Update Submit

January 19, 2023

Conditions

Liver Functions

Keywords

Fatty liverPhysical activityTreadmillExercises

Outcome Measures

Primary Outcomes (7)

  • Bilirubin-Total

    Blood level of Bilirubin-Total was measured.

    12 weeks.

  • Serum aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT)

    Blood level of Serum AST/SGOT was measured.

    12 weeks.

  • Serum alanine transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT)

    Blood level of Serum ALT/SGPT was measured.

    12 weeks.

  • Alkaline Phosphatase

    Blood level of Alkaline Phosphatase was measured.

    12 weeks.

  • Protein-Total

    Blood level of Protein-Total was measured.

    12 weeks.

  • Albumin

    Blood level of Albumin was measured.

    12 weeks.

  • Globulin

    Blood level of Globulin was measured.

    12 weeks.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Aerobic training program was performed by participants.

Other: Aerobic training

Control group

NO INTERVENTION

No intervention was performed by the participants.

Interventions

Aerobic trainingOTHER

Exercises on a treadmill at different speeds and inclination were performed.

Experimental Group

Eligibility Criteria

Age21 Years - 24 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Age: 21-24 years
  • Healthy
  • Athletes

You may not qualify if:

  • history of severe illness,
  • surgery, or damage to liver,
  • fatty liver disease,
  • cirrhosis,
  • blood infections,
  • neuromuscular illnesses,
  • or the presence of any disorders such as fever, high blood pressure, high blood sugar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud University

Riyadh, 11433, Saudi Arabia

Location

MeSH Terms

Conditions

Fatty LiverMotor Activity

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesBehavior

Study Officials

  • Masood Khan, M.P.Th

    King Saud University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2023

First Posted

January 30, 2023

Study Start

September 1, 2021

Primary Completion

July 14, 2022

Study Completion

November 30, 2022

Last Updated

January 30, 2023

Record last verified: 2023-01

Locations

SA(1)