- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02168712
Interval Versus Continuous Training on Functional Capacity and Quality of Life in Patients With Coronary Artery Disease
Interval Versus Continuous Exercise Training on Functional Capacity and Quality of Life in Patients With Coronary Artery Disease: a Randomized Clinical Trial
Exercise therapy increase functional capacity improving the morbidity and mortality of patients with cardiovascular disease. Moderate continuous training is the best established training modality for this patients. However, a body of evidence has begun to emerge demonstrating that high intensity interval training obtained better results in terms of morbidity and mortality.
The purpose of this randomized clinical trial was to determine the effect of two types of exercise training: moderate continuous training vs high interval training on functional capacity and quality of life as well as verify the safety in its application.
We included 72 patients with coronary artery disease by assigning one of the training modality for 8 weeks. We analyzed cyclo-ergo-spirometry data, aspect related to quality of life as well as a record of adverse events.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Madrid
-
Valdemoro, Madrid, Spanien, 28342
- Hospital Infanta Elena
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Coronary heart Disease, with functional class II-III according to New York Heart Association classification system.
- At least 4 weeks from acute cardiac event, percutaneous or surgery revascularization.
- Optimized medical treatment in adequate doses ( betablockers, ACE inhibitors, ARA II, statins and antiplatelet drugs)
- Age > 18 years old.
- Willing to participate and sign an informed consent form
Exclusion Criteria:
- Residual ischemia waiting for revascularization.
- Any cardiac event for the last 4 weeks
- Abnormal Ergometry with hemodynamic or clinically significant arrhythmias during the procedure.
- History of severe ventricular arrhythmia
- Uncontrolled glycaemia or blood pressure
- Moderate to severe Chronic Pulmonary Obstructive Disease
- Osteomuscular and/or mental disorder that hampers an adequate adherence to the intervention program
- Other vascular diseases: rheumatologic/ autoimmune disorders, thrombopathies, hemophilia.
- Active oncologic disease.
- Treatment with corticosteroids.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Moderate continuous exercise training
Moderate intensity continuous exercise training
|
|
|
Experimentell: Interval exercise training
High intensity interval exercise training
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Impact on functional capacity
Tidsram: 2 months
|
Basal and peak oxygen consumption values will be measured.
|
2 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
quality of life
Tidsram: 2 months
|
Quality of life will be compared between the two arms with one generic questionnaire (SF-36) and one ischemic heart disease specific questionnaire (MacNew)
|
2 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of Adverse Events
Tidsram: 2 months
|
The incidence of cardiovascular adverse events in each group will be compared
|
2 months
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EO31/2013-HIE
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