Congenital Heart DiseaseNCT05425173
Limbs Range of Motion Exercises Along With Chest Physical Therapy After Correction of Congenital Heart Diseases in ICU
A study testing Conventional treatment and Limb Range of Motion Exercises + Chest Physical Therapy in people with Congenital Heart Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
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 Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Conventional treatment and Limb Range of Motion Exercises + Chest Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jun 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients below the age 5 years old that underwent congenital heart surgery.
Who cannot join
- Contraindications for exercise, mental retardation, unstable hemodynamics
Trial locations and contacts
1 site in 1 country.
About this study
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
- 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
- Conditions
- Congenital Heart Disease
- Being tested
- Conventional treatment, Limb Range of Motion Exercises + Chest Physical Therapy
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional treatmentOther
Chest Physical Therapy as required
Limb Range of Motion Exercises + Chest Physical TherapyOther
Limb Range of Motion Exercises + Chest Physical Therapy
Frequency: 4 sessions Time: 5 to 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | Active comparator | Chest Physical Therapy Receives: Other: Conventional treatment |
| Limb Range of Motion Exercises + Chest Physical Therapy | Experimental | Limb Range of Motion Exercises + Chest Physical Therapy Receives: Other: Limb Range of Motion Exercises + Chest Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Changes from baseline, Heart rate was measured per minute through cardiac monitor
Measured: Upto 10 days
Respiration Rate
Changes from baseline,respiratory rate was measured per minute through cardiac monitor
Measured: Upto 10 days
Systolic Blood Pressure
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Measured: Upto 10 days
Diastolic Blood Pressure
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Measured: Upto 10 days
Partial pressure of oxygen
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Measured: Upto 10 days
Partial Pressure of carbon dioxide
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Measured: 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
Measured: 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
Measured: 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.
Measured: Upto 10 days
Ejection fraction
Change from baseline Ejection fraction through Echocardiography
Measured: Upto 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start20 Jun 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Iqbal Tariq, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425173
- Sponsor's protocol ID
- Muneeba Gul
- Status last verified
- Jan 2023
- First submitted
- 15 Jun 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05425173
- Acronym / sponsor ID
- Muneeba Gul
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | Active comparator | Other: Conventional treatmentChest Physical Therapy |
| Limb Range of Motion Exercises + Chest Physical Therapy | Experimental | Other: Limb Range of Motion Exercises + Chest Physical TherapyLimb Range of Motion Exercises + Chest Physical Therapy |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients below the age 5 years old that underwent congenital heart surgery.
Key exclusion criteria (1 listed)
- Contraindications for exercise, mental retardation, unstable hemodynamics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional treatmentChest Physical Therapy as required | Other | Conventional treatment |
| Limb Range of Motion Exercises + Chest Physical TherapyLimb Range of Motion Exercises + Chest Physical Therapy Frequency: 4 sessions Time: 5 to 10 minutes | Other | Limb Range of Motion Exercises + Chest Physical Therapy |
Primary outcome
Heart Rate
Time frame: Upto 10 days
Changes from baseline, Heart rate was measured per minute through cardiac monitor
Respiration Rate
Time frame: Upto 10 days
Changes from baseline,respiratory rate was measured per minute through cardiac monitor
Systolic Blood Pressure
Time frame: Upto 10 days
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Diastolic Blood Pressure
Time frame: Upto 10 days
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Partial pressure of oxygen
Time frame: Upto 10 days
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Partial Pressure of carbon dioxide
Time frame: Upto 10 days
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Arterial blood gas (ABG) parameter like potential of hydrogen (PH)
Time frame: Upto 10 days
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).
Time frame: Upto 10 days
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
Time frame: Upto 10 days
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
Time frame: Upto 10 days
Change from baseline Ejection fraction through Echocardiography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Iqbal Tariq, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional treatment and Limb Range of Motion Exercises + Chest Physical Therapy in people with Congenital Heart Disease, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (time frame: Upto 10 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.