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A controlled trial to compare the effect of Powerbreathe medic plus and Threshold IMT device on maximal inspiratory pressure and functional capacity in children underwent VSD closure

EFFECT OF POWERBREATHE MEDIC PLUS VERSUS THRESHOLD IMT ON MAXIMAL INSPIRATORY PRESSURE AND FUNCTIONAL CAPACITY IN POST-OPERATIVE VENTRICULAR SEPTAL DEFECT CLOSURE: A RANDOMIZED CONTROLLED TRIAL.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/051090
Enrollment
60
Registered
2023-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I52- Other heart disorders in diseasesclassified elsewhere

Interventions

Intervention1: PowerBreathe Medic Plus: Power Breathe is a pressure based threshold device that allows air flow during an inspiration only after reaching a certain inspiratory pressure, which is adjus

Sponsors

Research Cell
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients clinically diagnosed with isolated VSD. Patient operated for VSD closure. Patientâ??s attender who will sign the consent form. Patient with ability to understand and follow instructions

Exclusion criteria

Exclusion criteria: VSD associated with other congenital conditions such as Downâ??s syndrome, Williamâ??s syndrome, Noonan syndrome, Turner syndrome. Patients on post-operative mechanical ventilator.

Design outcomes

Secondary

MeasureTime frame
1 Power breathe medic plus 2 Threshold IMTTimepoint: Baseline, after 4 weeks and after 8 weeks

Primary

MeasureTime frame
1 MicroRPM (respiratory pressure meter). 2 6 MWD (minute walk distance). 3 Pulmonary Function Test Timepoint: Baseline, after 4 weeks , after 8 weeks

Countries

India

Contacts

Public ContactChitrakshi A Choubisa

Head of the Cardio-Respiratory Department

vishnu.vardhan@dmiher.edu.in8379917421

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026