- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02009475
The Effect of Two Exercise Training Protocols on Physiological and Biochemical Parameters in Congestive Heart Failure
The aim of the present study is to evaluate differential lactate removal kinetics in heart failure patients that are trained according to 2 different exercise protocols:
(A) High intensity intervals training (HIT); (B) Continuous moderate aerobic training (MAT)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Introduction: Congestive heart failure (CHF) patients suffer from early fatigue and functional aerobic impairment. Their reduced cardiac output and O2 delivery to the peripheral muscles shifts those patients consistent anaerobic metabolism, thus, CHF patients rely on anaerobic metabolism even in everyday life activity. This metabolism leads to a shift of muscles fiber types from mainly slow twitch, oxidative type I fibers to fast twitch, glycolytic type IIb fibers. Monocarboxylate proteins MCT1 and MCT4 transport lactate crosses the membrane. MCT1 is responsible for the lactate uptake and MCT4 is responsible for efflux of excess lactate. Exercise training is known to improve the quality of life in CHF. We hypothesized that exercise training might change MCT1 and 4 expression and distribution. Accordingly, these changes may also affect lactate clearance during recovery, which may contribute to the beneficial effect of exercise training in CHF patients. Methods: New-York Heart association (NYHA) class II-III CHF patients will be assigned to the experiment. At baseline and upon training conclusion they will undergo the same tests battery. The test battery includes heart rate, blood pressure measurements, echocardiographic evaluation. All participants will fill out "Minnesota living with heart failure" questionnaire. Subsequently, after their basal blood lactate will be assessed they will undergo measurement which will be followed by lactate clearance-rate evaluation.
Randomly each patient will then be assigned to one of two experimental training groups: (A) High intensity intervals training (HIT); (B) Continuous moderate aerobic training (MAT). Each volunteer will be trained twice a week for 12 weeks, according to his/hers assigned training protocol and in accordance to exercise training guidelines.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Tel Hashomer , Ramat Gan, Israel
- Sheba Medical Center, Cardiac Rehabilitation Institute
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Stable heart failure patients referred to exercise training in a tertiary care cardiac rehabilitation institute
- Age > 21
Exclusion Criteria:
- Severe symptomatic heart failure
- Severe orthopedic limitations
- Unstable arrythmia
- Cognitive decline or substance abuse
- Unable to comply with exercise protocol
- Significant pulmonary disease
- NYHA 4 heart failure class
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Continues aerobic training
Treadmill or exercise bike training with target heart rate of 50-70% of the heart rate reserve (or 50-60% of the peak VO2 reserve).
Overall 45 minutes of exercise (including the 5-10 minute warm-up period).
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Eksperimentell: Interval Exercse Training
Bouts of high intensity interval treadmill or exercise bike training, comprising of 85-95% of the heart rate reserve (or 80-90% of the peak VO2 reserve), for the duration of 4 minutes, separated by periods of low intensity activity until the heart rate reaches 50% of the peak heart rate.
This set will be repeated 3 times.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Lactate clearance kinetics
Tidsramme: Baseline and following 12 weeks of training
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Change from baseline of lactate clearance kinetics followoing a 12 weeks exercise program based on two different training protocol (continues and interval training)
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Baseline and following 12 weeks of training
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Peak VO2 change
Tidsramme: Pre- and post 12 week exercise program
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Change from baseline of the peak VO2 following the 12 weeks exercise program
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Pre- and post 12 week exercise program
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Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Quality of life questioner (MLWHF)
Tidsramme: Pre training and 12 weeks later post exercise training period
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Pre training and 12 weeks later post exercise training period
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LACT_HF_KIN
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