Virtual Reality on Pulmonary Function After Upper Abdominal Surgeries

Not Applicable

Recruiting

• Conditions: Abdomen Hernia; Respiratory Complication
• Interventions: Other: Virtual reality; Other: conventional physical therapy exercise program

• Registration Number: NCT06301126
• Lead Sponsor: Cairo University

Brief Summary

After upper abdomen surgery, respiratory muscle dysfunction is well recognised. After laparotomy and even laparoscopy, maximum static inspiratory and expiratory pressures are lowered, and recovery can take several days. A variety of reasons have been implicated in such respiratory muscle dysfunction, including irritation and inflammation, as well as injuries near the diaphragm, resulting in local mechanical failure, reflex inhibition, and pain.

Detailed Description

Virtual reality (VR) encourages an environment that attempts to create a moment of entertainment, motivation, and enjoyment with a variety of stimuli, with movements that stimulate physical and cognitive development, as well as the patient's active participation in the rehabilitation process. It is possible to assist in the alleviation of pain using the platform, at a low cost, through the playfulness given during rehabilitation, with an effective consumption of oxygen, range of motion, and use of the respiratory muscles more efficiently.

Participants with upper abdominal surgery will be randomly distributed into Group A (VR Group) which will receive VR for plus conventional physical therapy program and Group B (Control Group) which will receive conventional physical therapy program.

Study Timeline

• Study First Submitted: 2024-02-26
• Status Verified: 2024-03
• Study Start: 2024-03-01
• Study First Submitted QC: 2024-03-02
• Study First Posted: 2024-03-08
• Last Update Submitted: 2024-03-09
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-02-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients undergone open upper abdominal surgery (hernia repair, cholecystectomy, large bowel removal, conventional laparotomy)
2. no prior surgical intervention for esophageal, gastric, or biliary tract resection
3. age 18-60 years
4. acceptable physical condition (permitting pulmonary function and functional capacity test).

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Exclusion Criteria

1. Cerebrovascular disease
2. use of immunosuppressants within 30 days of surgery
3. cardiovascular instability
4. chest physical therapy within the 8 weeks preceding study enrollment
5. visual impairment or hearing impairment;
6. bed-ridden patients;
7. any lung disorders
8. insulin-dependent diabetes mellitus
9. less than 6-months post thoracic or cardiac surgery
10. musculoskeletal impairment
11. cognitive disorders
12. Patients undergoing laparoscopic surgery as this induces smaller changes in the postoperative breathing mechanics than laparotomy does
13. heavy smokers or alcoholism

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality	conventional physical therapy exercise program	Participants will receive VR for 20 minutes followed by conventional physical therapy program for 45 minutes, 5 days/ week for 8 weeks.
Virtual reality	Virtual reality	Participants will receive VR for 20 minutes followed by conventional physical therapy program for 45 minutes, 5 days/ week for 8 weeks.
Control	conventional physical therapy exercise program	Participants will receive conventional physical therapy program (Deep diaphragmatic, costal breathing exercises, bronchial hygiene techniques and assisted cough) for 45 minutes, 5 days/ week for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Forced vital capacity (FVC)	8 weeks	FVC will be measured by using spirometer.

Secondary Outcome Measures

Name	Time	Method
Forced expiratory volume in 1 second (FEV1)	8 weeks	FEV1 will be measured by using spirometer.
Respiratory muscle strength	8 weeks	The inspiratory muscle strength will be verified by means of the maximum inspiratory pressure (MIP) and the expiratory muscular strength by means of maximum expiratory pressure (MEP) by using the digital Manovacuometer.
diaphragmatic mobility	8 weeks	Diaphragmatic mobility will be assessed using a high resolution ultrasound machine with a convex probe of 3.5 MHz on the right subcostal area in perpendicular incidence to craniocaudal axis in the assessment.
Functional capacity	8 weeks	Functional capacity will be measured by using 6-Minute Walk Test (6-MWT) that measures the maximum distance walked in a period of 6 min to assess the submaximal level of the functional capacity of the participants.
Peak expiratory flow (PEF)	8 weeks	PEF will be measured by using spirometer.

Trial Locations

Locations (1)

Faculty of Physical Therapy; 🇪🇬 Giza, Egypt