An interventional study of INTERVENTION GROUP and CONTROL GROUP in Quality of Life, Congenital Heart Disease and Heart; Surgery, Heart, Functional Disturbance as Result, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Riphah International University · Not applicable, Interventional, and Treatment
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.
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 46 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
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Exclusion Criteria:
Preoperative Exercise therapy Patient Education, and post-operative conventional protocol.
Other: INTERVENTION GROUP
Patient Education, and post-operative conventional protocol.
Other: CONTROL 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
Preoperative: Patients' parents will be educated about the disease process, surgery, it's possible complications, and precautions. Postoperative: Conventional protocol of respective cardiac setup
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).
Time frame: 4 weeks
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.
Time frame: 4 weeks
Abnormal heart rhythms
pre-operative to post-operative and discharge day observed through Electrocardiography (ECG) on cardiac monitor.
Time frame: 7 days
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
Time frame: 4 weeks
Forced vital capacity
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
Plan to share: No
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Riphah International University