Abdomen HerniaNCT06301126
Virtual Reality on Pulmonary Function After Upper Abdominal Surgeries
A study testing Virtual reality and conventional physical therapy exercise program in people with Abdomen Hernia and Respiratory Complication, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Abdomen Hernia, Respiratory Complication
- What is being tested?
- Virtual reality and conventional physical therapy exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Abdomen Hernia, Respiratory Complication
- Being tested
- Virtual reality, conventional physical therapy exercise program
- Keywords
- Virtual reality, Pulmonary Function, Respiratory Muscle Strength, Functional Capacity, Upper abdominal surgery
- Medical subject headings
- Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: conventional physical therapy exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital capacity (FVC)
FVC will be measured by using spirometer.
Measured: 8 weeks
Secondary outcomes (5)
Forced expiratory volume in 1 second (FEV1)
FEV1 will be measured by using spirometer.
Measured: 8 weeks
Peak expiratory flow (PEF)
PEF will be measured by using spirometer.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Mar 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdomen HerniaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Morgan Allam, Cairo University
- Investigators
- Hadaya M Eladl, PhD, Study chair, Assistant professor of physical therapy for surgery, Faculty of physical therapyNabil M Abdel-Aal, PhD, Study director, Assistant professor of physical therapy for basic sciences, Faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301126
- Sponsor's protocol ID
- P.T.REC/012/004985
- Status last verified
- May 2024
- First submitted
- 26 Feb 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality on Pulmonary Function, Respiratory Muscle Strength and Functional Capacity After Upper Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT06301126
- Acronym / sponsor ID
- P.T.REC/012/004985
- Conditions
- Abdomen Hernia, Respiratory Complication
- Keywords
- Virtual reality, Pulmonary Function, Respiratory Muscle Strength, Functional Capacity, Upper abdominal surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Other: Virtual reality, Other: conventional physical therapy exercise programParticipants will receive VR for 20 minutes followed by conventional physical therapy program for 45 minutes, 5 days/ week for 8 weeks. |
| Control | Active comparator | Other: conventional physical therapy exercise programParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityThe 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 | Virtual reality |
| conventional physical therapy exercise programParticipants 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. | Other | Control, Virtual reality |
Primary outcome
Forced vital capacity (FVC)
Time frame: 8 weeks
FVC will be measured by using spirometer.
5 secondary outcomes
Forced expiratory volume in 1 second (FEV1)
Time frame: 8 weeks
Peak expiratory flow (PEF)
Time frame: 8 weeks
Respiratory muscle strength
Time frame: 8 weeks
diaphragmatic mobility
Time frame: 8 weeks
Functional capacity
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: Yes. Study results
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Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left Diaphragmatic Hernia (CDH)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and conventional physical therapy exercise program in people with Abdomen Hernia and Respiratory Complication, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced vital capacity (FVC) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.