NCT03543904

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2019

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

7 months

First QC Date

May 5, 2018

Last Update Submit

April 25, 2020

Conditions

Abdominal Surgery

Keywords

AbdomenChildrenChest physical therapySurgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 6 minute walk test

    2 times (recorded pre operative and post operative on day 5)

  • 10 meter walk test

    3 times (recorded pre operative and post operative on day1 and 5)

  • Nine stair climbing test

    2 times (recorded pre operative and post operative on day 5)

  • Timed up and go test

    3 times (recorded pre operative and post operative on day1 and 5)

Other Outcomes (4)

  • Change in FEV1 (Liters) (Spirometeric measurements)

    3 times (recorded pre operative and post operative on day1 and 5)

  • Change in FEV1/ FVC (%) (Spirometric measurements)

    2 times (recorded pre operative and post operative on day 5)

  • Change in PEFR (Liters) [Peak Expiratory Flow Rate (liters)] (Spirometeric measurements)

    3 times (recorded pre oprative and post operative on day1 and 5)

  • +1 more other outcomes

Study Arms (2)

Pre-operative physiotherapy education

EXPERIMENTAL

Pre-operative education regarding post-operative physiotherapy intervention and post-operative physiotherapy intervention in children with abdominal surgery

Procedure: Pre-operative physiotherapy educationProcedure: 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

Procedure: Post-operative physiotherapy intervention

Interventions

Pre-operative physiotherapy educationPROCEDURE

Pre-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

Pre-operative physiotherapy education
Post-operative physiotherapy interventionPROCEDURE

Post-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

Post-OP PT without Pre-OP educationPre-operative physiotherapy education

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric surgery ward, Maharishi Markandeshwar Hospital, Mullana

Ambāla, Haryana, 133207, India

Location

Related Publications (4)

  • 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.

    PMID: 29367198BACKGROUND

  • 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.

    PMID: 23405020BACKGROUND

  • 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.

    PMID: 26666321BACKGROUND

  • 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.

    PMID: 26436600BACKGROUND

Related Links

Study Officials

  • Neha Sharma, BPT, MPT

    Maharishi Markandeshwar institute of physiotherapy and Rehabilitation, MM(DU)

    PRINCIPAL INVESTIGATOR

  • Satya Sree, MS, MCh

    HOD, Department of Pediatric surgery, MMIMSR, MM(DU), Mullana, Haryana

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants were blinded towards which group they were allocated. If participants know that they were belonging to the experimental group 1 then they will be performing better than the participants in allocated in the experimental group 2.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor and Research Scholar

Study Record Dates

First Submitted

May 5, 2018

First Posted

June 1, 2018

Study Start

August 1, 2018

Primary Completion

March 4, 2019

Study Completion

March 16, 2019

Last Updated

April 28, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

by Publication in Mendeley Data set

Time Frame
13 May, 2019 to ever
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
More information

Available IPD Datasets

Pilot study Access
Individual Participant Data Set (Version 1)Access
Clinical Study Report Access

Locations

IN(1)