Virtual Reality on Pulmonary Function After Upper Abdominal Surgeries

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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Complication; Abdomen Hernia
• Intervention / Treatment: Other: Virtual reality; Other: conventional physical therapy exercise program

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nesma M Allam, PhD; Phone Number: +201281968332; Email: dr.nesma2011@yahoo.com

Study Locations

• Egypt
  • Giza, Egypt, 12111
    • Recruiting
    • Faculty of physical therapy
    • Contact: Nesma M Allam, PhD; Phone Number: +201281968332; Email: dr.nesma2011@yahoo.com

Participation Criteria

Eligibility Criteria

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

Description

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

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
Experimental: Virtual reality; Participants will receive VR for 20 minutes followed by conventional physical therapy program for 45 minutes, 5 days/ week for 8 weeks.	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.; Other: 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.
Active Comparator: Control; 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced vital capacity (FVC)	FVC will be measured by using spirometer.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced expiratory volume in 1 second (FEV1)	FEV1 will be measured by using spirometer.	8 weeks
Peak expiratory flow (PEF)	PEF will be measured by using spirometer.	8 weeks
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
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
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Hadaya M Eladl, PhD, Assistant professor of physical therapy for surgery, Faculty of physical therapy; Study Director: Nabil M Abdel-Aal, PhD, Assistant professor of physical therapy for basic sciences, Faculty of physical therapy

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: March 2, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 9, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pulmonary Function; Virtual reality; Functional Capacity; Respiratory Muscle Strength; Upper abdominal surgery
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Internal Hernia
• Other Study ID Numbers: P.T.REC/012/004985

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study results
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: Study protocol
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No