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Active, not recruitingNCT06301126Updated May 14, 2025

Virtual Reality on Pulmonary Function After Upper Abdominal Surgeries

An interventional study of Virtual reality and conventional physical therapy exercise program in Abdomen Hernia and Respiratory Complication, sponsored by Cairo University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-14.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Abdomen Hernia
  • Respiratory Complication

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Keywords

  • Virtual reality
  • Pulmonary Function
  • Respiratory Muscle Strength
  • Functional Capacity
  • Upper abdominal surgery
03

In context

Hernia, Abdominal

82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.

This study's planned enrollment of 60 is below the median of 90 across 48 interventional studies indexed under Hernia, Abdominal.

Browse Hernia, Abdominal studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Cerebrovascular disease
  2. use of 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (estimated)

Study arms

  • 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 · Other: conventional physical therapy exercise program

  • 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

Interventions

  • OtherVirtual 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.

  • Otherconventional 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.

06

What researchers measure

Primary outcomes

  1. Forced vital capacity (FVC)

    FVC will be measured by using spirometer.

    Time frame: 8 weeks

Secondary outcomes

  1. Forced expiratory volume in 1 second (FEV1)

    FEV1 will be measured by using spirometer.

    Time frame: 8 weeks

  2. Peak expiratory flow (PEF)

    PEF will be measured by using spirometer.

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

  4. 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.

    Time frame: 8 weeks

  5. 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.

    Time frame: 8 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — Study results

Supporting information: Study protocol, Informed consent form

Time frame: 6 months after publication

Access criteria: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06301126
Lead sponsor
Cairo University
Responsible party
Nesma Morgan Allam (Assistant Professor of physical therapy for surgery, Faculty of physical therapy, Cairo University) — Principal investigator
First posted
Mar 8, 2024
Start date
Mar 1, 2024
Primary completion
Jun 1, 2025 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
May 14, 2025

Study contacts

Hadaya M Eladl, PhD
study chair · Assistant professor of physical therapy for surgery, Faculty of physical therapy
Nabil M Abdel-Aal, PhD
study director · Assistant professor of physical therapy for basic sciences, Faculty of physical therapy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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