Free Walking Exercise in Obstructive Sleep Apnea Patients With Non-alcoholic Fatty Liver

Impact of Free Walking Exercise on Obstructive Sleep Apnea Patients With Non-alcoholic Fatty Liver on Liver Enzymes, Degree of Exhaustion, and Quality of Sleep

Research evaluating the impact of continuous positive airway pressure (CPAP) & walking exercise on fatigue severity, liver enzymes and sleeping quality in patients with non-alcoholic fatty liver disease who also have obstructive sleep apnea. Forty patients are divided into two groups: twenty patients CPAP and other twenty patients for CPAP and walking program .

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; Non-alcoholic Fatty Liver
• Intervention / Treatment: Behavioral: continuous positive airway pressure; Behavioral: free walking exercise and continuous positive airway pressure

Detailed Description

Research evaluating the impact of continuous positive airway pressure (CPAP) & walking exercise on fatigue severity, liver enzymes and sleeping quality in patients with non-alcoholic fatty liver disease who also have obstructive sleep apnea. Forty patients are divided into two groups: twenty patients CPAP and other twenty patients for CPAP and walking program .

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: El-Hadidy Hagar, PHD; Phone Number: 00201007453552; Email: hagarhadidy2016@gmail.com
• Study Contact Backup: Name: El-gohary Ola, PHD; Phone Number: 01227191398

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Ahram Canadian University
    • Contact: hagar El-Hadidy, lecturer; Email: hagarhadidy2016@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The body mass index (BMI) < 35 kg/m2.
• obstructive sleep apnea patients with fatty liver

Exclusion Criteria:

• liver transplantation , alcoholic fatty liver, antipsychotic medications, bariatric surgery; cardiac , renal problem , liver cancer ; pregnancy,orthopedic problems, systemic diseases, respiratory dysfunctions, neurological dysfunctions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: continuous positive airway pressure therapy; The continuous positive airway pressure therapy equipment is used for 12 weeks, all patients in this group groups must utilize the CPAP machine for 4 hours each night.	Behavioral: continuous positive airway pressure; continuous positive airway pressure therapy for a period of 12 weeks, all patients with in this group are required to utilize the CPAP machine for at least 4 hours each night
Experimental: Free walking & continuous positive airway pressure therapy; Each patient is required to walk 30 minutes, seven days a week for 12 weeks. & The continuous positive airway pressure therapy equipment is used for 12 weeks, all patients in both groups must utilize the CPAP machine for 4 hours each night.	Behavioral: free walking exercise and continuous positive airway pressure; patients will receive continuous positive airway pressure therapy for a period of 12 weeks, all patients with in this group are required to utilize the CPAP machine for at least 4 hours each night. Also, patients will perform walking exercise for 30 mint, daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alanine tranaminase	serum hepatic enzyme	it will be measured after 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asparatate transamianse	serum hepatic enzyme	it will be measured after 12 weeks
Body mass index	it will be masusured on empty stomach and bladder	it will be measured after 12 weeks
triglycerodes	it will be meausred in plasma	it will be assessed after 12 weeks
Pittsiburg sleeping quality index	a questionnaire that wil be used for assessing sleeping quality	it will be assessed after 12 weeks
fatigue severity scale	a questionnaire that wil be used for assessing fatigue	it will be assessed after 12 weeks
Epworth sleepness scale	a questionnaire that wil be used for daytime sleepness	it will be assessed after 12 weeks

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Principal Investigator: El-Hadidy Hagar, Faculty of Physical Therapy, Ahram Canadian University (ACU), Giza, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 13, 2024
• First Submitted That Met QC Criteria: July 13, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 13, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Liver Diseases; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Fatty Liver; Apnea; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 03202405263221

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No