Clinical trial NCT04034082: Intermittent Hypoxia Therapy in Cardiac Rehabilitation
Official title: Effect of Intermittent Hypoxia Therapy on Functional Capacity in Geriatric Cardiac Patients With Functional Impairment During a Cardiac Rehabilitation Program: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Exercise
Hypoxia
Keywords: cardiovascular disease
rehabilitation
exercise
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 30
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 interspersed with normoxic periods delivered by an ad hoc device - might be a valuable tool to be associated to structured cardiac rehabilitation (CR) interventions.

The present study is a pilot, monocentric, randomized (randomization ratio 1:1), parallel group study to assess the effect of IHT on functional capacity vs conventional care in old patients with functional impairment admitted to a phase 2 in-hospital cardiac rehabilitation program.

The study will enroll cardiac patients of both genders, ≥ 75 years and with a functional impairment assessed by a Short Physical Performance Battery (SPPB) score \< 7.

The effect of IHT on functional capacity will be evaluated on top of the conventional multidisciplinary CR intervention, by means of SPPB score variation; variations in quality of life and cognitive status will also be evaluated as secondary goals of the study.

The total amount of IHT sessions per patient will be 10, 1 per day over 2 weeks, the duration of each single procedure will be 45 min and the Hypoxic O2 conc.% will be 14-10. The study was approved by local ethic committee.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Changes in SPPB score
timeFrame: 30 days
Secondary outcomes:
measure: Changes in distance at the 6-min walking test
timeFrame: 30 days
measure: Changes in peak exercise oxygen uptake (peak VO2)
timeFrame: 30 days
measure: Changes in basal blood pressure
timeFrame: 30 days
measure: Changes in basal heart rate
timeFrame: 30 days
measure: Changes in EuroQoL score
timeFrame: 30 days
measure: Changes in geriatric depression scale
timeFrame: 30 days
measure: Changes in minimental state evaluation
timeFrame: 30 days
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri IRCCS
Study officials:
affiliation: ICS Maugeri care and Research Institute, Pavia, Italy
name: Roberto Pedretti, MD
role: STUDY_CHAIR
References: