Exercise Training in Children With Corrective Cardiac Surgeries

Sponsor
Riphah International University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05763238
Collaborator
(none)
46
1
2
11.1
4.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: INTERVENTION GROUP
  • Other: CONTROL GROUP
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Pre-operative Exercise Therapy on Postoperative Outcomes in Children With Corrective Cardiac Surgeries.
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interventional Group

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

Other: INTERVENTION GROUP
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

Active Comparator: Control group

Patient Education, and post-operative conventional protocol.

Other: CONTROL GROUP
Preoperative: Patients' parents will be educated about the disease process, surgery, it's possible complications, and precautions. Postoperative: Conventional protocol of respective cardiac setup

Outcome Measures

Primary Outcome Measures

  1. Health related Quality of life [4 weeks]

    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).

  2. Post-operative Pulmonary complications [4 weeks]

    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.

  3. Abnormal heart rhythms [7 days]

    pre-operative to post-operative and discharge day observed through Electrocardiography (ECG) on cardiac monitor.

  4. Forced Expiratory Volume in 1 second (FEV1) [4 weeks]

    Changes from pre-operative to post-operative, discharge day, and 15 days after discharge measured through the digital spirometer in Liters

  5. Forced vital capacity [4 Weeks]

    Changes from pre-operative to post-operative, discharge day, and 15 days after discharge measured through the digital spirometer in Liters.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Diagnosed with congenital heart disease and 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 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Armed forces institute of cardiology Rawalpindi Punjab Pakistan 4400

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Mehwish Waseem, MSPT(CPPT), Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05763238
Other Study ID Numbers:
  • Rec/01386 Kanwal Zaheer
First Posted:
Mar 10, 2023
Last Update Posted:
Mar 10, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2023