Clinical trial NCT03543904: Pre-operative and Post-operative Physiotherapy in Children With Abdominal Surgery
Official title: Effects of Pre- Operative Physiotherapy Education and Post Operative Physiotherapy in Children With Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Surgery
Keywords: Abdomen
Children
Chest physical therapy
Surgery
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 21
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in FVC (Liters) (spirometric measurements)
timeFrame: 3 times (recorded pre operative and post operative on day1 and 5)
Secondary outcomes:
measure: 6 minute walk test
timeFrame: 2 times (recorded pre operative and post operative on day 5)
measure: 10 meter walk test
timeFrame: 3 times (recorded pre operative and post operative on day1 and 5)
measure: Nine stair climbing test
timeFrame: 2 times (recorded pre operative and post operative on day 5)
measure: Timed up and go test
timeFrame: 3 times (recorded pre operative and post operative on day1 and 5)
Other outcomes:
measure: Change in FEV1 (Liters) (Spirometeric measurements)
timeFrame: 3 times (recorded pre operative and post operative on day1 and 5)
measure: Change in FEV1/ FVC (%) (Spirometric measurements)
timeFrame: 2 times (recorded pre operative and post operative on day 5)
measure: Change in PEFR (Liters) [Peak Expiratory Flow Rate (liters)] (Spirometeric measurements)
timeFrame: 3 times (recorded pre oprative and post operative on day1 and 5)
measure: Chest expansion test
timeFrame: 3 times (recorded pre operative and post operative on day1 and 5)
Locations:
city: Ambala
country: India
facility: Pediatric surgery ward, Maharishi Markandeshwar Hospital, Mullana
state: Haryana
Study officials:
affiliation: Maharishi Markandeshwar institute of physiotherapy and Rehabilitation, MM(DU)
name: Neha Sharma, BPT, MPT
role: PRINCIPAL_INVESTIGATOR
affiliation: HOD, Department of Pediatric surgery, MMIMSR, MM(DU), Mullana, Haryana
name: Satya Sree, MS, MCh
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.