Cardiovascular DiseaseNCT04034082
Intermittent Hypoxia Therapy in Cardiac Rehabilitation
A study testing Intermittent hypoxia therapy and Conventional phase 2 cardiac rehabilitation programme in people with Cardiovascular Disease and Exercise, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Cardiovascular Disease, Exercise, Hypoxia
- What is being tested?
- Intermittent hypoxia therapy and Conventional phase 2 cardiac rehabilitation programme
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 12 Feb 2019to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cardiovascular Disease, Exercise, Hypoxia
- Being tested
- Intermittent hypoxia therapy, Conventional phase 2 cardiac rehabilitation programme
- Keywords
- cardiovascular disease, rehabilitation, exercise
- Medical subject headings
- Cardiovascular Diseases, Motor Activity, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent hypoxia therapyDevice
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.
Conventional phase 2 cardiac rehabilitation programmeOther
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..
| Study group | Role | What they receive |
|---|---|---|
| IHT group | Experimental | Intermittent hypoxia therapy on top of the conventional phase 2 in-hospital rehabilitation program Receives: Device: Intermittent hypoxia therapy; Other: Conventional phase 2 cardiac rehabilitation programme |
| Conventional group | Active comparator | Conventional phase 2 in-hospital rehabilitation program Receives: Other: Conventional phase 2 cardiac rehabilitation programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (7)
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
Measured: 30 days
Changes in peak exercise oxygen uptake (peak VO2)
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.
Measured: 30 days
Changes in basal blood pressure
Expressed by means of mmHg. Indicator of haemodynamic status.
Measured: 30 days
Changes in basal heart rate
Expressed by means of number of beats per minute. Indicator of haemodynamic status.
Measured: 30 days
Changes in EuroQoL score
European Quality of Life score (EuroQoL). Score: from 0 (lowest condition) to 10 (best condition).
Measured: 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).
Measured: 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)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start12 Feb 2019
- Primary completion30 Jun 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto Pedretti, MD, Study chair, ICS Maugeri care and Research Institute, Pavia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034082
- Sponsor's protocol ID
- 2233CE
- Status last verified
- Jul 2019
- First submitted
- 22 Jul 2019
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04034082
- Acronym / sponsor ID
- 2233CE
- Conditions
- Cardiovascular Disease, Exercise, Hypoxia
- Keywords
- cardiovascular disease, rehabilitation, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IHT group | Experimental | Device: Intermittent hypoxia therapy, Other: Conventional phase 2 cardiac rehabilitation programmeIntermittent hypoxia therapy on top of the conventional phase 2 in-hospital rehabilitation program |
| Conventional group | Active comparator | Other: Conventional phase 2 cardiac rehabilitation programmeConventional phase 2 in-hospital rehabilitation program |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent hypoxia therapyIntermittent 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. | Device | IHT group |
| Conventional phase 2 cardiac rehabilitation programmeThe 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.. | Other | Conventional group, IHT group |
Primary outcome
Changes in SPPB score
Time frame: 30 days
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.
7 secondary outcomes
Changes in distance at the 6-min walking test
Time frame: 30 days
Changes in peak exercise oxygen uptake (peak VO2)
Time frame: 30 days
Changes in basal blood pressure
Time frame: 30 days
Changes in basal heart rate
Time frame: 30 days
Changes in EuroQoL score
Time frame: 30 days
Changes in geriatric depression scale
Time frame: 30 days
Changes in minimental state evaluation
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Pedretti, MD study chair
ICS Maugeri care and Research Institute, Pavia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent hypoxia therapy and Conventional phase 2 cardiac rehabilitation programme in people with Cardiovascular Disease and Exercise, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in SPPB score (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.