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Trial record 42 of 66 for:    strength | ( Map: India )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03543904
Recruitment Status : Completed
First Posted : June 1, 2018
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Asir John Samuel, Maharishi Markendeswar University

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.

Condition or disease Intervention/treatment Phase
Abdominal Surgery Procedure: Pre-operative physiotherapy education Procedure: Post-operative physiotherapy intervention Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Effects of Pre- Operative Physiotherapy Education and Post Operative Physiotherapy in Children With Abdominal Surgery
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : March 4, 2019
Actual Study Completion Date : March 16, 2019

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,

  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: Post-operative physiotherapy intervention

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

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,

  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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 6 minute walk test [ Time Frame: 2 times (recorded pre operative and post operative on day 5) ]
    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. 10 meter walk test [ Time Frame: 3 times (recorded pre operative and post operative on day1 and 5) ]
    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. Nine stair climbing test [ Time Frame: 2 times (recorded pre operative and post operative on day 5) ]
    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.

  4. Timed up and go test [ Time Frame: 3 times (recorded pre operative and post operative on day1 and 5) ]
    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.


Other Outcome Measures:
  1. Change in FEV1 (Liters) (Spirometeric measurements) [ Time Frame: 3 times (recorded pre operative and post operative on day1 and 5) ]
    Forced expiratory volume in the first second (FEV1) Is the volume expired in the first second of maximal expiration after a full inspiration

  2. Change in FEV1/ FVC (%) (Spirometric measurements) [ Time Frame: 2 times (recorded pre operative and post operative on day 5) ]
    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

  3. Change in PEFR (Liters) [Peak Expiratory Flow Rate (liters)] (Spirometeric measurements) [ Time Frame: 3 times (recorded pre oprative and post operative on day1 and 5) ]
    Inspiratory vital capacity (IVC) is the maximum volume of air inhaled from the point of maximum expiration

  4. Chest expansion test [ Time Frame: 3 times (recorded pre operative and post operative on day1 and 5) ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543904


Locations
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India
Pediatric surgery ward, Maharishi Markandeshwar Hospital, Mullana
Ambala, Haryana, India, 133207
Sponsors and Collaborators
Asir John Samuel
Investigators
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Principal Investigator: Neha Sharma, BPT, (MPT) Maharishi Markandeshwar institute of physiotherapy and rehabilitation
Study Director: Satya Sree, MS, MCh HOD, Department of Pediatric surgery, Maharishi Markandeshwar Institute of Medical sciences and Research

Additional Information:
Publications:
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Responsible Party: Asir John Samuel, Associate Professor and Research Scholar, Maharishi Markendeswar University
ClinicalTrials.gov Identifier: NCT03543904     History of Changes
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 )
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: by Publication in Mendeley Data set
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
URL: http://dx.doi.org/10.17632/skkt9tsjd3.1

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asir John Samuel, Maharishi Markendeswar University:
Abdomen
Children
Chest physical therapy
Surgery