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

NCT06508190 | Recruiting

• 1 other identifier: 03202405263221
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Obstructive Sleep Apnea; Non-alcoholic Fatty Liver

Outcome Measures

Primary Outcomes (1)

• Alanine tranaminase

  serum hepatic enzyme

  it will be measured after 12 weeks

Secondary Outcomes (6)

• Asparatate transamianse

  it will be measured after 12 weeks

• Body mass index

  it will be measured after 12 weeks

• triglycerodes

  it will be assessed after 12 weeks

• Pittsiburg sleeping quality index

  it will be assessed after 12 weeks

• fatigue severity scale

  it will be assessed after 12 weeks

Study Arms (2)

continuous positive airway pressure therapy

ACTIVE COMPARATOR

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

Free walking & continuous positive airway pressure therapy

EXPERIMENTAL

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

Interventions

continuous positive airway pressure BEHAVIORAL

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

continuous positive airway pressure therapy

free walking exercise and continuous positive airway pressure BEHAVIORAL

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

Free walking & continuous positive airway pressure therapy

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Ahram canadian university

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Non-alcoholic Fatty Liver Disease

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• El-Hadidy Hagar

  Faculty of Physical Therapy, Ahram Canadian University (ACU), Giza, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

El-Hadidy Hagar, PHD

CONTACT

00201007453552; hagarhadidy2016@gmail.com

El-gohary Ola, PHD

CONTACT

01227191398

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The authors of this clinical trial and patients do not provide the study outcome examiners with information regarding device therapy or free walking exercise.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Forty patients suffering from obstructive sleep apnea are divided into two groups: one for CPAP and the other for CPAP and free walking program.

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: July 18, 2024
• Study Start: July 12, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

EG (1)