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

Primary Purpose

Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional treatment
Limb Range of Motion Exercises + Chest Physical Therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications for exercise, mental retardation, unstable hemodynamics

Sites / Locations

  • Rehman Medical Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional treatment

Limb Range of Motion Exercises + Chest Physical Therapy

Arm Description

Chest Physical Therapy

Limb Range of Motion Exercises + Chest Physical Therapy

Outcomes

Primary Outcome Measures

Heart Rate
Changes from baseline, Heart rate was measured per minute through cardiac monitor
Respiration Rate
Changes from baseline,respiratory rate was measured per minute through cardiac monitor
Systolic Blood Pressure
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Diastolic Blood Pressure
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Partial pressure of oxygen
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Partial Pressure of carbon dioxide
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
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
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
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.
Ejection fraction
Change from baseline Ejection fraction through Echocardiography

Secondary Outcome Measures

Full Information

First Posted
June 15, 2022
Last Updated
January 22, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05425173
Brief Title
Limbs Range of Motion Exercises Along With Chest Physical Therapy After Correction of Congenital Heart Diseases in ICU
Official Title
Effect of Limbs Range of Motion Exercises Along With Chest Physical Therapy on Cardiopulmonary Parameters After Correction of Congenital Heart Diseases in ICU
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

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
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
Chest Physical Therapy
Arm Title
Limb Range of Motion Exercises + Chest Physical Therapy
Arm Type
Experimental
Arm Description
Limb Range of Motion Exercises + Chest Physical Therapy
Intervention Type
Other
Intervention Name(s)
Conventional treatment
Intervention Description
Chest Physical Therapy as required
Intervention Type
Other
Intervention Name(s)
Limb Range of Motion Exercises + Chest Physical Therapy
Intervention Description
Limb Range of Motion Exercises + Chest Physical Therapy Frequency: 4 sessions Time: 5 to 10 minutes
Primary Outcome Measure Information:
Title
Heart Rate
Description
Changes from baseline, Heart rate was measured per minute through cardiac monitor
Time Frame
Upto 10 days
Title
Respiration Rate
Description
Changes from baseline,respiratory rate was measured per minute through cardiac monitor
Time Frame
Upto 10 days
Title
Systolic Blood Pressure
Description
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Time Frame
Upto 10 days
Title
Diastolic Blood Pressure
Description
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Time Frame
Upto 10 days
Title
Partial pressure of oxygen
Description
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Time Frame
Upto 10 days
Title
Partial Pressure of carbon dioxide
Description
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Time Frame
Upto 10 days
Title
Arterial blood gas (ABG) parameter like potential of hydrogen (PH)
Description
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
Time Frame
Upto 10 days
Title
Arterial blood gas parameter like bicarbonate(HCO3).
Description
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
Time Frame
Upto 10 days
Title
Oxygen saturation
Description
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.
Time Frame
Upto 10 days
Title
Ejection fraction
Description
Change from baseline Ejection fraction through Echocardiography
Time Frame
Upto 10 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients below the age 5 years old that underwent congenital heart surgery. Exclusion Criteria: Contraindications for exercise, mental retardation, unstable hemodynamics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Iqbal Tariq, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehman Medical Institute
City
Peshawar
State/Province
Khyber PkahtoonKhwa
ZIP/Postal Code
25000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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