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Intermittent Hypoxia Therapy in Cardiac Rehabilitation

NCT04034082 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-12-15

No results posted yet for this study

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 2 in-hospital cardiac rehabilitation program.

Conditions

Interventions

DEVICE

Intermittent hypoxia therapy

Intermittent Hypoxic Therapy (further referred to as IHT). A typical IHT session consists of repeated short-term moderate hypoxia (down to 10 vol.% O2), interrupted by brief periods of reoxygenation. These periods of recovery could be either normoxic (21 vol.% O2, Hypoxia-Normoxia mode) or hyperoxic (30-35 vol.% O2, Hypoxia-Hyperoxia mode, further referred to as IHHT). The gas mixtures are supplied to a patient via facial mask.

OTHER

Conventional phase 2 cardiac rehabilitation programme

The core components of a Phase 2 in-hospital cardiac rehabilitation program include: 1) patient assessment with medical control to promote clinical stabilization and optimization of pharmacologic treatment; 2) physical activity counselling; 3) prescription of an individualized exercise training; 4) diet/nutritional counselling; 5) weight control management; 6) Lipid management; 7) blood pressure monitoring and management; 8) smoking cessation; 9) vocational support; 10) psychosocial management..

Sponsors & Collaborators

  • Istituti Clinici Scientifici Maugeri SpA

    lead OTHER

Principal Investigators

  • Roberto Pedretti, MD · ICS Maugeri care and Research Institute, Pavia, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-12
Primary Completion
2020-06-30
Completion
2020-10-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04034082 on ClinicalTrials.gov