Limbs Range of Motion Exercises Along With Chest Physical Therapy After Correction of Congenital Heart Diseases in ICU

Effect of Limbs Range of Motion Exercises Along With Chest Physical Therapy on Cardiopulmonary Parameters After Correction of Congenital Heart Diseases in ICU

1. To determine the effect of limb ROMs along with chest Physical therapy on cardiopulmonary parameters after correction of congenital heart diseases in ICU
2. To determine the response of Inotropic drug in relation to Limb ROMs after Correction of Congenital heart diseases in ICU

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Other: Conventional treatment; Other: Limb Range of Motion Exercises + Chest Physical Therapy

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Khyber PkahtoonKhwa
    • Peshawar, Khyber PkahtoonKhwa, Pakistan, 25000
      • Rehman Medical Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients below the age 5 years old that underwent congenital heart surgery.

Exclusion Criteria:

• Contraindications for exercise, mental retardation, unstable hemodynamics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional treatment; Chest Physical Therapy	Other: Conventional treatment; Chest Physical Therapy as required
Experimental: Limb Range of Motion Exercises + Chest Physical Therapy	Other: Limb Range of Motion Exercises + Chest Physical Therapy; Limb Range of Motion Exercises + Chest Physical Therapy Frequency: 4 sessions Time: 5 to 10 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Changes from baseline, Heart rate was measured per minute through cardiac monitor	Upto 10 days
Respiration Rate	Changes from baseline,respiratory rate was measured per minute through cardiac monitor	Upto 10 days
Systolic Blood Pressure	Changes from the Baseline, Blood pressure is measured through sphygmomanometer	Upto 10 days
Diastolic Blood Pressure	Changes from the Baseline, Blood pressure is measured through sphygmomanometer	Upto 10 days
Partial pressure of oxygen	Changes from the Baseline, Blood pressure is measured through sphygmomanometer	Upto 10 days
Partial Pressure of carbon dioxide	Changes from the Baseline, Blood pressure is measured through sphygmomanometer	Upto 10 days
Arterial blood gas (ABG) parameter like potential of hydrogen (PH)	Above parameter was measured by serial ABG analysis. Its normal reference range is 7.35-7.45. baseline reading will be taken at 10 minutes before starting Non invasive ventilation training. Changes from the Baseline	Upto 10 days
Arterial blood gas parameter like bicarbonate(HCO3).	Above parameter was measured by serial ABG analysis. Its normal reference range is 22-28 nmol/L. Baseline reading will be taken at 10 minutes before starting Non invasive ventilation training. Changes from the Baseline	Upto 10 days
Oxygen saturation	Changes from baseline SPO2 was measured in percentage. Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood. Pulse oximeter measure it.	Upto 10 days
Ejection fraction	Change from baseline Ejection fraction through Echocardiography	Upto 10 days

Collaborators and Investigators

• Sponsor: Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 22, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: Muneeba Gul

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No