- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07775742
Effect of High-Intensity Interval Training Versus Home-Based Rehabilitation Program On Patients Underwent Coronary Artery Bypass Graft Surgery
18. august 2026 oppdatert av: Mohammed Obaid Almuzaini, Kafrelsheikh University
Effect of High-Intensity Interval Training Versus Home-Based Rehabilitation Program on Peak Metabolic Equivalents On Patients Underwent Coronary Artery Bypass Graft Surgery
- To assess the effect of high-intensity interval training on peak metabolic equivalents in patients with coronary heart disease after the coronary artery bypass grafting surgery.
- To assess the effect of a home-based cardiac rehabilitation program on peak metabolic equivalents in patients with coronary heart disease after coronary artery bypass grafting surgery.
- To compare functional outcomes between the different treatment approaches.
Studieoversikt
Status
Rekruttering
Detaljert beskrivelse
Cardiovascular disease (CVD), a leading cause of death in the U.S., is primarily driven by coronary artery disease (CAD), which accounts for 85% of related fatalities.
The Coronary Artery Bypass Grafting (CABG) procedure, used to treat blocked arteries, can lead to complications like reduced cardiopulmonary function and decreased physical activity post-surgery.
To combat these issues, cardiac rehabilitation (CR) is recommended, incorporating exercise, dietary changes, and stress reduction.
Research indicates that CR, particularly high-intensity interval training (HIIT), is safe for coronary artery disease patients and effectively enhances cardiopulmonary fitness.
Maintaining exercise capacity is critical as it significantly correlates with improved survival rates in Cardiovascular disease patients.
Despite evidence supporting cardiac rehabilitation's benefits, participation rates remain low, highlighting a need for sustained exercise habits post-rehabilitation.
Home-based CR has shown effectiveness comparable to outpatient programs, although long-term benefits remain uncertain due to insufficient follow-up studies.
Studietype
Intervensjonell
Registrering (Antatt)
84
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mohammed O Almuzaini, PT
- Telefonnummer: +966540044491
- E-post: Pt.mohammedobaid@gmail.com
Studiesteder
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Madinah, Saudi-Arabia
- Rekruttering
- Medina Cardiac Center
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Ta kontakt med:
- Mohammed Obaid Almuzaini, physical therapist
- Telefonnummer: +966540044491
- E-post: Pt.mohammedobaid@gmail.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Participants will be eligible if they are clinically stable as defined by the American College of Cardiology/American Heart Association.
- Only Participants will be stratified as low to moderate risk as identified by the American College of Sport Medicine/
- Mean age ± standard deviation, 55 ± 3 years.
- All patients underwent coronary artery bypass graft surgery, rested at home for at least one month, and then returned to the center for a cardiac rehabilitation program
Exclusion Criteria:
- Patients will be excluded from this study if they had an ejection fraction of less than 40% at rest (high risk as defined by American Association of Cardiovascular and Pulmonary Rehabilitation Stratification).
- Mental health disorders (such an anxiety or depression).
- Any vision or hearing defects or any neurological, respiratory, or musculoskeletal conditions that have an impact on ambulation.
- Irreversible heart failure.
- Myocardial Infarction (MI) over the past month.
- Persistent ventricular arrhythmias or unstable angina.
- Any exercise restrictions.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: High Intensity Interval Training program
Twenty-eight patients will receive a high-intensity interval training program for four weeks
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High-Intensity Interval Training (HIIT) includes a 5-minute warm-up, followed by a 3-minute training session at 60% to 70% of heart rate reserve and four 4-minute high-intensity intervals at 80% to 90% of heart rate reserve.
Each interval is followed by a 3-minute active recovery at 60% to 70% of heart rate reserve, concluding with a 4-minute cool-down.
Subjects without balance or leg issues performed treadmill exercises, while those with such complaints used a leg ergo-cycle.
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Eksperimentell: home-based cardiac rehabilitation intervention
Twenty-eight patients will receive a home-based cardiac rehabilitation intervention for four weeks
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The home-based cardiac rehabilitation program utilizes Physio-tools software for exercise management.
Participants will receive a data sheet for exercise logging, a color-coded program, and a Polar watch.
Weekly phone support will provide encouragement and answer questions.
The program involves moderate-intensity exercises, 3 times a week, including circuit training for 45 minutes, with structured warm-up, aerobic, and cool-down phases.
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Aktiv komparator: no intervention
all participants will be given an instruction booklet that contains instructions and precautions about surgery, wound care and encouragement to be active.
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The control group had no intervention program.
Based on current standard practice, all participants will be given an instruction booklet that contains instructions and precautions about surgery, wound care and encouragement to be active.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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assessment of Exercise capacity
Tidsramme: At baseline and after 4 weeks
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Exercise capacity will be evaluated through a symptom-limited graded treadmill exercise test following the Bruce protocol, starting at 1.7 mph and a 10% incline.
The intensity will increase every 3 minutes until the participant reaches exhaustion or meets clinical termination criteria.
Capacity will be measured in metabolic equivalents (METs), with peak metabolic equivalents calculated based on the highest workload achieved.
Estimated oxygen consumption will be expressed in mL·kg-¹·min-¹ and converted to METs.
The main outcome will be the change in peak metabolic equivalents from baseline to post-intervention assessment.
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At baseline and after 4 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juli 2026
Primær fullføring (Antatt)
1. desember 2026
Studiet fullført (Antatt)
1. februar 2027
Datoer for studieregistrering
Først innsendt
28. juli 2026
Først innsendt som oppfylte QC-kriteriene
18. august 2026
Først lagt ut (Faktiske)
20. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Mohamed_Msc
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