Intermittent Hypoxia Therapy in Cardiac Rehabilitation

NCT04034082 | Completed

• 1 other identifier: 2233CE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 2 in-hospital cardiac rehabilitation program.

Conditions

Cardiovascular Disease; Exercise; Hypoxia

Keywords

cardiovascular disease; rehabilitation; exercise

Outcome Measures

Primary Outcomes (1)

• Changes in SPPB score

  The Short Physical Performance Battery (SPPB) is a series of physical performance tests used in older persons to assess lower extremity function and mobility. Score total: minimum 0 (lowest performance), maximum 12 (highest performance). Three subscales (minimum 0, maximum 4 points each one): balance test, gait speed test, chair stand test.

  30 days

Secondary Outcomes (7)

• Changes in distance at the 6-min walking test

  30 days

• Changes in peak exercise oxygen uptake (peak VO2)

  30 days

• Changes in basal blood pressure

  30 days

• Changes in basal heart rate

  30 days

• Changes in EuroQoL score

  30 days

Study Arms (2)

IHT group

EXPERIMENTAL

Intermittent hypoxia therapy on top of the conventional phase 2 in-hospital rehabilitation program

Device: Intermittent hypoxia therapy; Other: Conventional phase 2 cardiac rehabilitation programme

Conventional group

ACTIVE COMPARATOR

Conventional phase 2 in-hospital rehabilitation program

Other: Conventional phase 2 cardiac rehabilitation programme

Interventions

Intermittent hypoxia therapy DEVICE

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.

IHT group

Conventional phase 2 cardiac rehabilitation programme OTHER

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..

Conventional group; IHT group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity; Hypoxia

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roberto Pedretti, MD

  ICS Maugeri care and Research Institute, Pavia, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 26, 2019
• Study Start: February 12, 2019
• Primary Completion: June 30, 2020
• Study Completion: October 30, 2020
• Last Updated: December 15, 2021

Record last verified: 2019-07

Locations

IT (1)