Status:
COMPLETED
Intermittent Hypoxia Therapy in Cardiac Rehabilitation
Lead Sponsor:
Istituti Clinici Scientifici Maugeri SpA
Conditions:
Cardiovascular Disease
Exercise
Eligibility:
All Genders
75+ years
Phase:
NA
Brief Summary
This is a randomized control pilot study to assess the effect of intermittent hypoxia therapy on functional capacity vs conventional care in old patients with functional impairment admitted to a Phase...
Detailed Description
Because the improvement of exercise tolerance reduces mortality in elderly patients affected by cardiovascular disease, intermittent hypoxia therapy (IHT) - defined as repeated episodes of hypoxia int...
Eligibility Criteria
Inclusion
- Admission to a Phase 2 in-hospital cardiac rehabilitation program because of a recent index event;
- Provision of signed and dated informed consent form;
- Age ≥ 75 years;
- Basic venous blood oxygen saturation (SpO2) level \> 93% measured at the fingertip;
- SPPB score \< 7;
- New York Heart Association (NYHA) Class I-III.
Exclusion
- Inability to give informed consent (diminished understanding or comprehension);
- Age \< 75 years;
- SPPB Score ≥ 7;
- NYHA Class IV and/or concomitant i.v. therapy with cardiovascular active drugs;
- Uncontrolled angina pectoris;
- Uncontrolled arterial hypertension;
- Uncontrolled atrial or ventricular arrhythmias;
- Active pericarditis or myocarditis;
- Need of continuous or intermittent O2 therapy;
- Hb \< 10 g/dl;
- Severe concomitant non-cardiac diseases such as cancer or any other systemic disease limiting to participate in the study
- Acute inflammatory diseases;
- Acute non-cardiac somatic diseases, or somatic diseases with symptoms of decompensation;
- Currently implanted left ventricular assist device;
- Inability to accept the procedure of breathing via facial mask.
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04034082
Start Date
February 12 2019
End Date
October 30 2020
Last Update
December 15 2021
Active Locations (1)
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1
Istituti Clinici Scientifici Maugeri IRCCS
Pavia, Italy, 27100