Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IHT group | Experimental | Intermittent hypoxia therapy on top of the conventional phase 2 in-hospital rehabilitation program |
|
| Conventional group | Active Comparator | Conventional phase 2 in-hospital rehabilitation program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in distance at the 6-min walking test | 6-min walking test is a test for functional evaluation based on walking distance performed by the patient in the time window at the individual walking speed. Score in meters: minimum zero, maximum indefinite | 30 days |
| Changes in peak exercise oxygen uptake (peak VO2) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Roberto Pedretti, MD | ICS Maugeri care and Research Institute, Pavia, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituti Clinici Scientifici Maugeri IRCCS | Pavia | 27100 | Italy |
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009043 | Motor Activity |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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.. |
|
Peak VO2 represents the maximal individualized oxygen consumption at the peak effort, evaluated by means of cardiopulmonary exercise testing, expressed by means of ml of oxygen per Kg of body weight per minute. |
| 30 days |
| Changes in basal blood pressure | Expressed by means of mmHg. Indicator of haemodynamic status. | 30 days |
| Changes in basal heart rate | Expressed by means of number of beats per minute. Indicator of haemodynamic status. | 30 days |
| Changes in EuroQoL score | European Quality of Life score (EuroQoL). Score: from 0 (lowest condition) to 10 (best condition). | 30 days |
| Changes in geriatric depression scale | 30 items with relative categorization (1 present; 0 absent). Minimum 0 points (absence of depression), maximum 30 point (highest grade of depression). | 30 days |
| Changes in minimental state evaluation | Tool for evaluation of cognitive status in older patients. Minimum score 0 (absence of cognitive impairment), maximum 30 (highest grade of cognitive impairment) | 30 days |