Pre-operative and Post-operative Physiotherapy in Children With Abdominal Surgery

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Surgery
• Intervention / Treatment: Procedure: Pre-operative physiotherapy education; Procedure: Post-operative physiotherapy intervention

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Ambala, Haryana, India, 133207
      • Pediatric surgery ward, Maharishi Markandeshwar Hospital, Mullana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Children who requires organ transplants
• With mental retardation
• With physical disability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-operative physiotherapy education; Pre-operative education regarding post-operative physiotherapy intervention and post-operative physiotherapy intervention in children with abdominal surgery	Procedure: Pre-operative physiotherapy education; 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; Procedure: Post-operative physiotherapy intervention; 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
Experimental: Post-OP PT without Pre-OP education; Post-operative physiotherapy intervention without pre-operative education in children with abdominal surgery	Procedure: Post-operative physiotherapy intervention; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 times (recorded pre operative and post operative on day1 and 5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	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.	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.	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.	3 times (recorded pre operative and post operative on day1 and 5)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FEV1 (Liters) (Spirometeric measurements)	Forced expiratory volume in the first second (FEV1) Is the volume expired in the first second of maximal expiration after a full inspiration	3 times (recorded pre operative and post operative on day1 and 5)
Change in FEV1/ FVC (%) (Spirometric measurements)	It is also known as Tiffeneau pinelli index (FEV1/FVC) represents the proportion of individual's vital capacity that they are able to expire in the first second of forced expiration to full, forced vital capacity	2 times (recorded pre operative and post operative on day 5)
Change in PEFR (Liters) [Peak Expiratory Flow Rate (liters)] (Spirometeric measurements)	Inspiratory vital capacity (IVC) is the maximum volume of air inhaled from the point of maximum expiration	3 times (recorded pre oprative and post operative on day1 and 5)
Chest expansion test	Chest expansion test measures the expansion of chest when the subject takes a deep breath. Chest expansion will be measured at 3 different levels. i.e 1.) Axillary level 2) Nipple level 3) xiphi-sternum level	3 times (recorded pre operative and post operative on day1 and 5)

Collaborators and Investigators

• Sponsor: Asir John Samuel
• Investigators: Principal Investigator: Neha Sharma, BPT, MPT, Maharishi Markandeshwar institute of physiotherapy and Rehabilitation, MM(DU); Study Director: Satya Sree, MS, MCh, HOD, Department of Pediatric surgery, MMIMSR, MM(DU), Mullana, Haryana

Publications and helpful links

General 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. Erratum In: BMJ. 2019 Apr 25;365:l1862.
• Soares 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.
• Boden 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.
• Katsura 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.

Helpful Links

• Preserving pulmonary function and functional capacity in children undergoing open abdominal surgery: A one group pretest-posttest, quasiexperimental pilot trial

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): March 4, 2019
• Study Completion (Actual): March 16, 2019

Study Registration Dates

• First Submitted: May 5, 2018
• First Submitted That Met QC Criteria: May 18, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 25, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Surgery; Children; Abdomen; Chest physical therapy
• Other Study ID Numbers: MMDU/IEC/1189; U1111-1213-2267 (Registry Identifier: Universal Trial Number (UTN)); L-79385/2018 (Other Identifier: Copyright office, Government of India)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: by Publication in Mendeley Data set
• IPD Sharing Time Frame: 13 May, 2019 to ever
• IPD Sharing Access Criteria: Sharma, Neha; Samuel, Asir John (2019), "Effect of Pre-operative physiotherapy education and Post-operative physiotherapy in children with abdominal surgery", Mendeley Data, v1 http://dx.doi.org/10.17632/skkt9tsjd3.1

Study Data/Documents

1. Pilot study
   Information comments: Preserving pulmonary function and functional capacity in children undergoing open abdominal surgery: A one group pretest-posttest, quasiexperimental pilot trial
2. Individual Participant Data Set
   Information identifier: Version 1
   Information comments: Effect of Pre-operative physiotherapy education and Post-operative physiotherapy in children with abdominal surgery", Mendeley Data, v1 http://dx.doi.org/10.17632/skkt9tsjd3.1
3. Clinical Study Report
   Information comments: A randomized clinical trial in improving pulmonary function and functional capacity in paediatric open abdominal surgery

Drug and device information, study documents

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