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Exercise Training in Children With Corrective Cardiac Surgeries

Primary Purpose

Quality of Life, Congenital Heart Disease, Heart; Surgery, Heart, Functional Disturbance as Result

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
INTERVENTION GROUP
CONTROL GROUP
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life focused on measuring Cardiopulmonary outcomes, Corrective cardiac surgeries, Preoperative Exercise therapy

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed with congenital heart disease Undergoing elective corrective cardiac surgery Vitally stable Exclusion Criteria: Having acquired heart disease or undergoing emergency cardiac surgeries Patients undergoing valvular repairing surgeries Functional status is limited due to conditions other than CHD or having any contraindications Inability to adhere to study protocols Participants who refused or withdrew from the study

Sites / Locations

  • Armed forces institute of cardiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional Group

Control group

Arm Description

Preoperative Exercise therapy Patient Education, and post-operative conventional protocol.

Patient Education, and post-operative conventional protocol.

Outcomes

Primary Outcome Measures

Health related Quality of life
Changes from pre-operative to 15 days after discharge from the hospital, measured through a Pediatric quality of life questionnaire consisting of 23 questions that are categorized into 4 major components namely, Physical functioning (8 items), Emotional functioning (5 items), Social functioning (5 items), School functioning (5 items). The scoring of the scale is based on the frequency of performance of particular activity ranging from 0 (mean never performed) to 5(mean always functioning).
Post-operative Pulmonary complications
Changes from pre-operative to post-operative, discharge day and 15 days after discharge from the hospital, measured through chest x-ray including Consolidation, Atelectasis, Pneumonitis, Pleural Effusion.
Abnormal heart rhythms
pre-operative to post-operative and discharge day observed through Electrocardiography (ECG) on cardiac monitor.
Forced Expiratory Volume in 1 second (FEV1)
Changes from pre-operative to post-operative, discharge day, and 15 days after discharge measured through the digital spirometer in Liters
Forced vital capacity
Changes from pre-operative to post-operative, discharge day, and 15 days after discharge measured through the digital spirometer in Liters.

Secondary Outcome Measures

Full Information

First Posted
February 28, 2023
Last Updated
March 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05763238
Brief Title
Exercise Training in Children With Corrective Cardiac Surgeries
Official Title
Effects of Pre-operative Exercise Therapy on Postoperative Outcomes in Children With Corrective Cardiac Surgeries.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the effects of preoperative exercise therapy on postoperative cardiopulmonary outcomes and quality of life in children with corrective cardiac surgeries.Within literature there is limited evidence on preoperative exercise therapy in the pediatric population, positive results of the study can introduce a new tradition of preoperative exercise therapy and significantly reduce post-operative complications. Secondary complications would also be addressed in the study, a positive result can reduce the total costs by reducing hospital stays and improving the quality of life of child.
Detailed Description
Cardiac surgeries are often associated with some post-operative cardiopulmonary complications most often cardiac arrhythmias, pulmonary atelectasis, and hospital induced pneumonia and reduced inspiratory capacities which can be reduced by exercise therapy this study is therefore significant not only for the determination of the effects of preoperative exercise therapy, it will also provide a path toward pre-habilitation followed by effective postoperative cardiac rehabilitation which is mostly lacking in many setups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Congenital Heart Disease, Heart; Surgery, Heart, Functional Disturbance as Result
Keywords
Cardiopulmonary outcomes, Corrective cardiac surgeries, Preoperative Exercise therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional Group
Arm Type
Experimental
Arm Description
Preoperative Exercise therapy Patient Education, and post-operative conventional protocol.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patient Education, and post-operative conventional protocol.
Intervention Type
Other
Intervention Name(s)
INTERVENTION GROUP
Intervention Description
Preoperative Protocol: DAY 1: Incentive spirometry 1 set of 2 repetitions(each repetition includes 05 deep inhalations) 3 times a day. Active ROMS (3 sets of 5 repetitions of both upper and lower limb thrice a day) Walk, Static marching to 10 steps thrice a day. DAY 2: Incentive spirometry 1 set of 3 repetitions (each repetition includes 08-10 deep inhalation) 3 times a day. Active ROMS, 3 sets of 5 repetitions of both upper and lower limb thrice a day) Walk, Static marching to 15 steps thrice a day. DAY 3: Incentive spirometry,1 set of 3 repetitions(each repetition includes 10 deep inhalation) 3 times a day Active ROMS 3 sets of 5 repetitions of both upper and lower limbs thrice a day. Walk, Static marching to 20 steps thrice a day. Postoperative Protocol: Conventional protocol of respective cardiac setup
Intervention Type
Other
Intervention Name(s)
CONTROL GROUP
Intervention Description
Preoperative: Patients' parents will be educated about the disease process, surgery, it's possible complications, and precautions. Postoperative: Conventional protocol of respective cardiac setup
Primary Outcome Measure Information:
Title
Health related Quality of life
Description
Changes from pre-operative to 15 days after discharge from the hospital, measured through a Pediatric quality of life questionnaire consisting of 23 questions that are categorized into 4 major components namely, Physical functioning (8 items), Emotional functioning (5 items), Social functioning (5 items), School functioning (5 items). The scoring of the scale is based on the frequency of performance of particular activity ranging from 0 (mean never performed) to 5(mean always functioning).
Time Frame
4 weeks
Title
Post-operative Pulmonary complications
Description
Changes from pre-operative to post-operative, discharge day and 15 days after discharge from the hospital, measured through chest x-ray including Consolidation, Atelectasis, Pneumonitis, Pleural Effusion.
Time Frame
4 weeks
Title
Abnormal heart rhythms
Description
pre-operative to post-operative and discharge day observed through Electrocardiography (ECG) on cardiac monitor.
Time Frame
7 days
Title
Forced Expiratory Volume in 1 second (FEV1)
Description
Changes from pre-operative to post-operative, discharge day, and 15 days after discharge measured through the digital spirometer in Liters
Time Frame
4 weeks
Title
Forced vital capacity
Description
Changes from pre-operative to post-operative, discharge day, and 15 days after discharge measured through the digital spirometer in Liters.
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with congenital heart disease Undergoing elective corrective cardiac surgery Vitally stable Exclusion Criteria: Having acquired heart disease or undergoing emergency cardiac surgeries Patients undergoing valvular repairing surgeries Functional status is limited due to conditions other than CHD or having any contraindications Inability to adhere to study protocols Participants who refused or withdrew from the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehwish Waseem, MSPT(CPPT)
Phone
0331-5309015
Email
mehwish.waseem@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehwish Waseem, MSPT(CPPT)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Armed forces institute of cardiology
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
4400
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehwish Waseem, MSPT(CPPT)
Phone
0331-5309015
Email
mehwish.waseem@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Kanwal Zaheer, MSPT(CPPT)*
Phone
0306 5324269
Email
kanwal.zaheer97@gmail.com
First Name & Middle Initial & Last Name & Degree
Kanwal Zaheer, MSPT(CPPT)*

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21059667
Citation
Valkenet K, van de Port IG, Dronkers JJ, de Vries WR, Lindeman E, Backx FJ. The effects of preoperative exercise therapy on postoperative outcome: a systematic review. Clin Rehabil. 2011 Feb;25(2):99-111. doi: 10.1177/0269215510380830. Epub 2010 Nov 8.
Results Reference
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PubMed Identifier
23152283
Citation
Hulzebos EH, Smit Y, Helders PP, van Meeteren NL. Preoperative physical therapy for elective cardiac surgery patients. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD010118. doi: 10.1002/14651858.CD010118.pub2.
Results Reference
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PubMed Identifier
20307858
Citation
Bernier PL, Stefanescu A, Samoukovic G, Tchervenkov CI. The challenge of congenital heart disease worldwide: epidemiologic and demographic facts. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2010;13(1):26-34. doi: 10.1053/j.pcsu.2010.02.005.
Results Reference
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Exercise Training in Children With Corrective Cardiac Surgeries

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