Virtual Reality on Pulmonary Function After Upper Abdominal Surgeries

NCT06301126 | Active Not Recruiting

• 1 other identifier: P.T.REC/012/004985
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdomen Hernia; Respiratory Complication

Keywords

Virtual reality; Pulmonary Function; Respiratory Muscle Strength; Functional Capacity; Upper abdominal surgery

Outcome Measures

Primary Outcomes (1)

• Forced vital capacity (FVC)

  FVC will be measured by using spirometer.

  8 weeks

Secondary Outcomes (5)

• Forced expiratory volume in 1 second (FEV1)

  8 weeks

• Peak expiratory flow (PEF)

  8 weeks

• Respiratory muscle strength

  8 weeks

• diaphragmatic mobility

  8 weeks

• Functional capacity

  8 weeks

Study Arms (2)

Virtual reality

EXPERIMENTAL

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; Other: conventional physical therapy exercise program

Control

ACTIVE COMPARATOR

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

Interventions

Virtual reality OTHER

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.

Virtual reality

conventional physical therapy exercise program OTHER

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.

Control; Virtual reality

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, 12111, Egypt

Location

MeSH Terms

Conditions

Hernia, Abdominal

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Hadaya M Eladl, PhD

  Assistant professor of physical therapy for surgery, Faculty of physical therapy

  STUDY CHAIR

• Nabil M Abdel-Aal, PhD

  Assistant professor of physical therapy for basic sciences, Faculty of physical therapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 8, 2024
• Study Start: March 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 6 months after publication
• Access Criteria: Study protocol

Locations

EG (1)