Abdominal SurgeryNCT03543904
Pre-operative and Post-operative Physiotherapy in Children With Abdominal Surgery
A study testing Pre-operative physiotherapy education and Post-operative physiotherapy intervention in people with Abdominal Surgery, run by Asir John Samuel at 1 site in India.
Trial summary
The study will be conducted in a pediatric surgery ward, department of pediatrics. Children between the ages of 5 to 17 years who underwent for abdominal surgery will be recruited by simple random sampling. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Abdominal Surgery
- What is being tested?
- Pre-operative physiotherapy education and Post-operative physiotherapy intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2018to 16 Mar 2019
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children having following abdominal incision- inguinal incision, left subcostal incision, right subcostal incision, kehr incision, McBurney incision, Transverse incison, thoraco-abdominal incison, Median and paramedian incision12
- Between ages of 5 to 17 years
- Who follows and obeys the commands
- Children who is willing to participate in the study
Who cannot join
- Children who requires organ transplants
- With mental retardation
- With physical disability
Trial locations and contacts
1 site in 1 country.
India1 site
Pediatric surgery ward, Maharishi Markandeshwar Hospital, Mullana
Ambāla, Haryana, 133207
About this study
Official title: Effects of Pre- Operative Physiotherapy Education and Post Operative Physiotherapy in Children With Abdominal Surgery
The study will be conducted in a pediatric surgery ward, department of pediatrics. Children between the ages of 5 to 17 years who underwent for abdominal surgery will be recruited by simple random sampling. Parents of all the potential participants will receive a written explanation of the trial and given written informed consent forms to be signed prior to their child being involved in the trial. Pre- op physiotherapy education is given to one experimental group and after surgery post operative treatment is given to both the experimental groups. spirometery, 6 minute walk test, 10 meter walk test, Timed up and go test and Nine star stair climbing test will be used for data collection.
Read the detailed description
Pre- operative education is given to the experimental group 1 only. Pre- op. physiotherapy education includes-
Pursed lip breathing exercises × 10 repetitions Diaphragmatic breathing exercises × 10 repetitions Leg ROM (active hip and knee flexion, extension and abduction exercises) and ankle toe movements exercises × 10 repititions
Post- op. physiotherapy will be given to both the experimental groups. it includes- On Post operative day 1
Deep breathing exercises- Pursed lip breathing exercises × Diaphragmatic breathing exercises (5 repetitions × 2 sets)
Segmental breathing exercises × 5 repetitions × 2 sets Incentive spirometer 10 breaths up to 600 cc (In three sets) per session Leg Range of motion exercises (active hip and knee flexion and extension exercises) × 5 repetitions × 2 sets Ankle and toe movements× 10 repetitions × 2 sets Ambulation program High sitting minimum of 2 min Static March for 1 min Walk for 5 min. every 2 hourly
Post operative day 2 Deep breathing exercises- Pursed lip breathing exercises × Diaphragmatic breathing exercises (5 repetitions × 2 sets) Segmental breathing exercises × 5 repetitions × 2 sets Incentive spirometer 10 breaths upto 600 cc (In three sets) per sessionThoracic expansion exercises- ACBT (Active cycles of breathing techniques)
Diaphragmatic breathing (10 rep.), deep breathing (5 sec. hold), huffing x 2 repetitions twice a day Walk for 10 min. every 2 hourly
Post operative day 3 Pursed lip breathing exercises x 10 repetitions x 2 sets Incentive spirometer 10 breaths upto 900cc (In three sets) per session Thoracic expansion exercises- ACBT Diaphragmatic breathing (5-10 rep.), deep breathing (5 sec. hold), huffing x 2 repetitions twice a day Walk for 15 min. every 2 hourly
Post operative day 4 Incentive spirometer/ 10breaths upto 900cc (In three sets) per session Walk for 20 min. every 4 hourly
Post operative day 5 Incentive spirometer / 10breaths upto 1000cc (In three sets) per session Stair climbing up to 9 steps in ascending and descending pattern for 5 minutes rest in between
- Conditions
- Abdominal Surgery
- Being tested
- Pre-operative physiotherapy education, Post-operative physiotherapy intervention
- Keywords
- Abdomen, Children, Chest physical therapy, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative physiotherapy educationProcedure or surgery
Pre-operative education regarding post-operative physiotherapy intervention in children with abdominal surgery which includes,
- Deep breathing exercises
- Pursed lip breathing exercises
- Diaphragmatic breathing exercises
- Leg ROM (active hip and knee flexion, extension and abduction exercises)
- Ankle toe movements exercises
Post-operative physiotherapy interventionProcedure or surgery
Post-operative physiotherapy intervention which includes,
- Deep breathing exercises
- Pursed lip breathing exercises
- Diaphragmatic breathing exercises
- Leg ROM (active hip and knee flexion, extension and abduction exercises)
- Ankle toe movements exercises
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative physiotherapy education | Experimental | Pre-operative education regarding post-operative physiotherapy intervention and post-operative physiotherapy intervention in children with abdominal surgery Receives: Procedure: Pre-operative physiotherapy education; Procedure: Post-operative physiotherapy intervention |
| Post-OP PT without Pre-OP education | Experimental | Post-operative physiotherapy intervention without pre-operative education in children with abdominal surgery Receives: Procedure: Post-operative physiotherapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FVC (Liters) (spirometric measurements)
Functional vital capacity (FVC) is the maximum volume of air which can be exhaled or inspired during a forced maneuver
Measured: 3 times (recorded pre operative and post operative on day1 and 5)
Secondary outcomes (4)
6 minute walk test
the child will be asked to walk far as possible for 6 minutes. Child will be encouraged in every minute for walking. At 6 minute, child will be asked to stop. If the participant stops at any time prior record the distance at which the oxygen saturation drops < 88%
Measured: 2 times (recorded pre operative and post operative on day 5)
10 meter walk test
The 10MWT assesses walking speed in meters per second over a short duration.The child will be asked to walk a set distance (10 meters). Time will be measured during walking. The distance covered is divided by the time it took the individual to walk that distance.
Measured: 3 times (recorded pre operative and post operative on day1 and 5)
Nine stair climbing test
It is performed for measuring functional strength and balance through ascending and descending a set number of steps. 2min. time will be given to complete the test. The patient should use the assistive device (if any) normally used to perform the activity at the time of testing.
Measured: 2 times (recorded pre operative and post operative on day 5)
Timed up and go test
The child starts in a seated position. The child will be tands up upon therapist's command walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the child is seated.
Measured: 3 times (recorded pre operative and post operative on day1 and 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start1 Aug 2018
- Primary completion4 Mar 2019
- Study completion16 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Abdominal SurgeryStudies of the same condition, open and under way.
- 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
- Model description
- Parallel
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Neha Sharma, BPT, MPT, Principal investigator, Maharishi Markandeshwar institute of physiotherapy and Rehabilitation, MM(DU)Satya Sree, MS, MCh, Study director, HOD, Department of Pediatric surgery, MMIMSR, MM(DU), Mullana, Haryana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543904
- Sponsor's protocol ID
- MMDU/IEC/1189
- Other IDs
- U1111-1213-2267, L-79385/2018
- Status last verified
- Apr 2020
- First submitted
- 5 May 2018
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: by Publication in Mendeley Data set
Publications
Boden I, Skinner EH, Browning L, Reeve J, Anderson L, Hill C, Robertson IK, Story D, Denehy L. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial. BMJ. 2018 Jan 24;360:j5916. doi: 10.1136/bmj.j5916.
PubMed 29367198Soares SM, Nucci LB, da Silva MM, Campacci TC. Pulmonary function and physical performance outcomes with preoperative physical therapy in upper abdominal surgery: a randomized controlled trial. Clin Rehabil. 2013 Jul;27(7):616-27. doi: 10.1177/0269215512471063. Epub 2013 Feb 12.
PubMed 23405020Boden I, Browning L, Skinner EH, Reeve J, El-Ansary D, Robertson IK, Denehy L. The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial. Trials. 2015 Dec 15;16:573. doi: 10.1186/s13063-015-1090-6.
PubMed 26666321Katsura M, Kuriyama A, Takeshima T, Fukuhara S, Furukawa TA. Preoperative inspiratory muscle training for postoperative pulmonary complications in adults undergoing cardiac and major abdominal surgery. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD010356. doi: 10.1002/14651858.CD010356.pub2.
PubMed 26436600
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre- Operative Physiotherapy Education and Post Operative Physiotherapy in Children With Abdominal Surgery
- ClinicalTrials.gov ID
- NCT03543904
- Acronym / sponsor ID
- MMDU/IEC/1189
- Conditions
- Abdominal Surgery
- Keywords
- Abdomen, Children, Chest physical therapy, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 4 Mar 2019 (actual)
- Study completion
- 16 Mar 2019 (actual)
- First posted
- 1 Jun 2018 (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.
The study will be conducted in a pediatric surgery ward, department of pediatrics. Children between the ages of 5 to 17 years who underwent for abdominal surgery will be recruited by simple random sampling. Parents of all the potential participants will receive a written explanation of the trial and given written informed consent forms to be signed prior to their child being involved in the trial. Pre- op physiotherapy education is given to one experimental group and after surgery post operative treatment is given to both the experimental groups. spirometery, 6 minute walk test, 10 meter walk test, Timed up and go test and Nine star stair climbing test will be used for data collection.
Detailed description
Pre- operative education is given to the experimental group 1 only. Pre- op. physiotherapy education includes-
Pursed lip breathing exercises × 10 repetitions Diaphragmatic breathing exercises × 10 repetitions Leg ROM (active hip and knee flexion, extension and abduction exercises) and ankle toe movements exercises × 10 repititions
Post- op. physiotherapy will be given to both the experimental groups. it includes- On Post operative day 1
Deep breathing exercises- Pursed lip breathing exercises × Diaphragmatic breathing exercises (5 repetitions × 2 sets)
Segmental breathing exercises × 5 repetitions × 2 sets Incentive spirometer 10 breaths up to 600 cc (In three sets) per session Leg Range of motion exercises (active hip and knee flexion and extension exercises) × 5 repetitions × 2 sets Ankle and toe movements× 10 repetitions × 2 sets Ambulation program High sitting minimum of 2 min Static March for 1 min Walk for 5 min. every 2 hourly
Post operative day 2 Deep breathing exercises- Pursed lip breathing exercises × Diaphragmatic breathing exercises (5 repetitions × 2 sets) Segmental breathing exercises × 5 repetitions × 2 sets Incentive spirometer 10 breaths upto 600 cc (In three sets) per sessionThoracic expansion exercises- ACBT (Active cycles of breathing techniques)
Diaphragmatic breathing (10 rep.), deep breathing (5 sec. hold), huffing x 2 repetitions twice a day Walk for 10 min. every 2 hourly
Post operative day 3 Pursed lip breathing exercises x 10 repetitions x 2 sets Incentive spirometer 10 breaths upto 900cc (In three sets) per session Thoracic expansion exercises- ACBT Diaphragmatic breathing (5-10 rep.), deep breathing (5 sec. hold), huffing x 2 repetitions twice a day Walk for 15 min. every 2 hourly
Post operative day 4 Incentive spirometer/ 10breaths upto 900cc (In three sets) per session Walk for 20 min. every 4 hourly
Post operative day 5 Incentive spirometer / 10breaths upto 1000cc (In three sets) per session Stair climbing up to 9 steps in ascending and descending pattern for 5 minutes rest in between
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel
| Arm | Type | Receives |
|---|---|---|
| Pre-operative physiotherapy education | Experimental | Procedure: Pre-operative physiotherapy education, Procedure: Post-operative physiotherapy interventionPre-operative education regarding post-operative physiotherapy intervention and post-operative physiotherapy intervention in children with abdominal surgery |
| Post-OP PT without Pre-OP education | Experimental | Procedure: Post-operative physiotherapy interventionPost-operative physiotherapy intervention without pre-operative education in children with abdominal surgery |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children having following abdominal incision- inguinal incision, left subcostal incision, right subcostal incision, kehr incision, McBurney incision, Transverse incison, thoraco-abdominal incison, Median and paramedian incision12
- Between ages of 5 to 17 years
- Who follows and obeys the commands
- Children who is willing to participate in the study
Key exclusion criteria (3 listed)
- Children who requires organ transplants
- With mental retardation
- With physical disability
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 |
|---|---|---|
| Pre-operative physiotherapy educationPre-operative education regarding post-operative physiotherapy intervention in children with abdominal surgery which includes, 1. Deep breathing exercises 2. Pursed lip breathing exercises 3. Diaphragmatic breathing exercises 4. Leg ROM (active hip and knee flexion, extension and abduction exercises) 5. Ankle toe movements exercises | Procedure or surgery | Pre-operative physiotherapy education |
| Post-operative physiotherapy interventionPost-operative physiotherapy intervention which includes, 1. Deep breathing exercises 2. Pursed lip breathing exercises 3. Diaphragmatic breathing exercises 4. Leg ROM (active hip and knee flexion, extension and abduction exercises) 5. Ankle toe movements exercises | Procedure or surgery | Post-OP PT without Pre-OP education, Pre-operative physiotherapy education |
Primary outcome
Change in FVC (Liters) (spirometric measurements)
Time frame: 3 times (recorded pre operative and post operative on day1 and 5)
Functional vital capacity (FVC) is the maximum volume of air which can be exhaled or inspired during a forced maneuver
4 secondary outcomes
6 minute walk test
Time frame: 2 times (recorded pre operative and post operative on day 5)
10 meter walk test
Time frame: 3 times (recorded pre operative and post operative on day1 and 5)
Nine stair climbing test
Time frame: 2 times (recorded pre operative and post operative on day 5)
Timed up and go test
Time frame: 3 times (recorded pre operative and post operative on day1 and 5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Background: PubMed 29367198Boden I, Skinner EH, Browning L, Reeve J, Anderson L, Hill C, Robertson IK, Story D, Denehy L. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial. BMJ. 2018 Jan 24;360:j5916. doi: 10.1136/bmj.j5916.
- Background: PubMed 23405020Soares SM, Nucci LB, da Silva MM, Campacci TC. Pulmonary function and physical performance outcomes with preoperative physical therapy in upper abdominal surgery: a randomized controlled trial. Clin Rehabil. 2013 Jul;27(7):616-27. doi: 10.1177/0269215512471063. Epub 2013 Feb 12.
- Background: PubMed 26666321Boden I, Browning L, Skinner EH, Reeve J, El-Ansary D, Robertson IK, Denehy L. The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial. Trials. 2015 Dec 15;16:573. doi: 10.1186/s13063-015-1090-6.
- Background: PubMed 26436600Katsura M, Kuriyama A, Takeshima T, Fukuhara S, Furukawa TA. Preoperative inspiratory muscle training for postoperative pulmonary complications in adults undergoing cardiac and major abdominal surgery. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD010356. doi: 10.1002/14651858.CD010356.pub2.
- Preserving pulmonary function and functional capacity in children undergoing open abdominal surgery: A one group pretest-posttest, quasiexperimental pilot trialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. by Publication in Mendeley Data set
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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.
Neha Sharma, BPT, MPT principal investigator
Maharishi Markandeshwar institute of physiotherapy and Rehabilitation, MM(DU)
Satya Sree, MS, MCh study director
HOD, Department of Pediatric surgery, MMIMSR, MM(DU), Mullana, Haryana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-operative physiotherapy education and Post-operative physiotherapy intervention in people with Abdominal Surgery, run by Asir John Samuel at 1 site in India.
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 3 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: finished, as of the sponsor's last update on 28 Apr 2020. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in FVC (Liters) (spirometric measurements) (time frame: 3 times (recorded pre operative and post operative on day1 and 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03543904, which also lists 4 linked publications.
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 28 Apr 2020.