NCT05425173

Brief Summary

  1. 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. 2.To determine the response of Inotropic drug in relation to Limb ROMs after Correction of Congenital heart diseases in ICU

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

June 20, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

June 15, 2022

Last Update Submit

January 22, 2023

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (10)

  • 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

Study Arms (2)

Conventional treatment

ACTIVE COMPARATOR

Chest Physical Therapy

Other: Conventional treatment

Limb Range of Motion Exercises + Chest Physical Therapy

EXPERIMENTAL

Limb Range of Motion Exercises + Chest Physical Therapy

Other: Limb Range of Motion Exercises + Chest Physical Therapy

Interventions

Conventional treatmentOTHER

Chest Physical Therapy as required

Conventional treatment
Limb Range of Motion Exercises + Chest Physical TherapyOTHER

Limb Range of Motion Exercises + Chest Physical Therapy Frequency: 4 sessions Time: 5 to 10 minutes

Limb Range of Motion Exercises + Chest Physical Therapy

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Contraindications for exercise, mental retardation, unstable hemodynamics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehman Medical Institute

Peshawar, Khyber PkahtoonKhwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Muhammad Iqbal Tariq, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 21, 2022

Study Start

June 20, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)