- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07775742
Effect of High-Intensity Interval Training Versus Home-Based Rehabilitation Program On Patients Underwent Coronary Artery Bypass Graft Surgery
18 augusti 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
84
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Mohammed O Almuzaini, PT
- Telefonnummer: +966540044491
- E-post: Pt.mohammedobaid@gmail.com
Studieorter
-
-
-
Madinah, Saudiarabien
- Rekrytering
- Medina Cardiac Center
-
Kontakt:
- Mohammed Obaid Almuzaini, physical therapist
- Telefonnummer: +966540044491
- E-post: Pt.mohammedobaid@gmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: High Intensity Interval Training program
Twenty-eight patients will receive a high-intensity interval training program for four weeks
|
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.
|
|
Experimentell: home-based cardiac rehabilitation intervention
Twenty-eight patients will receive a home-based cardiac rehabilitation intervention for four weeks
|
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.
|
|
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
assessment of Exercise capacity
Tidsram: At baseline and after 4 weeks
|
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.
|
At baseline and after 4 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juli 2026
Primärt slutförande (Beräknad)
1 december 2026
Avslutad studie (Beräknad)
1 februari 2027
Studieregistreringsdatum
Först inskickad
28 juli 2026
Först inskickad som uppfyllde QC-kriterierna
18 augusti 2026
Första postat (Faktisk)
20 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Mohamed_Msc
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .