HBET in patients with Fontan Circulation-RCT
Not Applicable
- Conditions
- Health Condition 1: 8- Other Procedures
- Registration Number
- CTRI/2022/10/046280
- Lead Sponsor
- Dr Gorav Sharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with Fontan circulation with Fontan surgery within preceding 6 years
Exclusion Criteria
Cardiac
Fontan surgery within 6 months
High risk Fontan (single lung repair, borderline or small PAs (McGoon index <1.8), elevated LVEDP, fenestration, more than moderate ventricular dysfunction, more than moderate AVVR, resting SPO2 <90%
Non-cardiac
Inability to perform exercise training/CPET or inability to follow up schedule, major musculoskeletal/intellectual disability
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine change in VO2max following 12 week of HBET in patients with Fontan circulationTimepoint: Recruitment and at 12 weeks
- Secondary Outcome Measures
Name Time Method To determine change in BNP levels, 6 minute walk distance following 12 week of HBET in patients with Fontan circulationTimepoint: Recruitment and at 12weeks