Virtual Reality on Pulmonary Function After Upper Abdominal Surgeries

Respiratory Complication Clinical Trial

Official title:

Effect of Virtual Reality on Pulmonary Function, Respiratory Muscle Strength and Functional Capacity After Upper Abdominal Surgeries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06301126
• Other study ID #: P.T.REC/012/004985
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: Nesma M Allam, PhD
• Phone: +201281968332
• Email: dr.nesma2011[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

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

Related Conditions & MeSH terms

• Hernia, Abdominal
• Internal Hernia
• Respiratory Complication

Intervention

Other:
• Virtual reality
The system included an Xbox 360® console, a sensor that detects motion (Kinect®), and a projector device with loudspeakers. The console, which was mounted on a table, reached 1 m tall. The Kinect® motion sensor was attached to the projector, which showed images onto a wall 2.5 metres distant from the playing field. The playing field was at least 1.8 m wide and 1.8 m long, with the Kinect® sensor situated 1.2 m away. The device was calibrated before each training session to accurately follow the motions of each subject.
• conventional physical therapy exercise program
Participants will receive conventional physical therapy exercise program (Deep diaphragmatic, costal breathing exercises, bronchial hygiene techniques and assisted cough) for 45 minutes, 5 days/ week for 8 weeks.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced vital capacity (FVC)	FVC will be measured by using spirometer.	8 weeks
Secondary	Forced expiratory volume in 1 second (FEV1)	FEV1 will be measured by using spirometer.	8 weeks
Secondary	Peak expiratory flow (PEF)	PEF will be measured by using spirometer.	8 weeks
Secondary	Respiratory muscle strength	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.	8 weeks
Secondary	diaphragmatic mobility	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.	8 weeks
Secondary	Functional capacity	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.	8 weeks