- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07619664
High-Intensity Interval Training vs Moderate-Intensity Continuous Training in Phase II Cardiac Rehabilitation
Effects of High-Intensity Interval Training vs Moderate-Intensity Continuous Training on Ejection Fraction, Functional Capacity, and Lipid Profiles in Phase II Cardiac Rehabilitation
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This randomized controlled trial will compare the effects of High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MICT) in patients undergoing Phase II cardiac rehabilitation after stable coronary artery disease or post-angioplasty. A total of 66 participants will be randomly assigned into two groups.
The HIIT group will perform treadmill-based interval exercise 3 times per week at 85-95% heart rate reserve with active recovery periods, while the MICT group will perform continuous treadmill exercise at 65-75% heart rate reserve for 30-45 minutes.
Primary outcomes include left ventricular ejection fraction (echocardiography), functional capacity (6-minute walk test), and lipid profile (LDL, HDL, triglycerides, total cholesterol) measured before and after intervention. Health-related quality of life (HRQoL) will also be assessed. The study aims to determine which exercise protocol produces greater improvement in cardiac and functional outcomes.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Muhammad Iqbal Tariq, Phd*
- Telefonnummer: 333826752
- E-mail: iqbal.tariq@riphah.edu.pk
Studiesteder
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Punjab Province
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Multan, Punjab Province, Pakistan, 60000
- Ch Pervaiz Elahi institute of cardiology Multan.
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Kontakt:
- Arjumand Bano, MS-CPPT
- Telefonnummer: 03059551883
- E-mail: arjumand.bano@riphah.edu.pk
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Ledende efterforsker:
- ALISHBA JAVED, MS-CPPT
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Adults aged 18-60 years.
- Diagnosed with stable coronary artery disease confirmed by angiography, stress testing, or echocardiography.
- Left ventricular ejection fraction ≥45%.
- Functional NYHA Class I or II.
- Medically cleared by a cardiologist to participate in exercise (including recent ECG or stress test if necessary).
- Lightly active lifestyle prior to study (not involved in structured exercise programs).
Exclusion Criteria:
- Unstable angina or recent myocardial infarction (within the past 6 weeks).
- Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg).
- Severe valvular heart disease, arrhythmias, or left ventricular dysfunction (EF <35%).
- Musculoskeletal disorders (e.g., severe osteoarthritis, recent fractures, or surgeries) preventing safe participation in exercise.
- Neurological disorders affecting mobility or safe exercise (e.g., stroke, Parkinson's disease).
- Uncontrolled diabetes mellitus (HbA1c >9% or recent hypoglycemia).
- Any other condition judged by the investigator to make participation unsafe.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: High-Intensity Interval Training (HIIT)
Participants will perform supervised treadmill-based high-intensity interval training 3 sessions per week, including 10-minute warm-up, 4 intervals of 4 minutes at 85-95% heart rate reserve, 4-minute active recovery at 50-60% heart rate reserve, followed by 5-minute cool-down.
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Participants will perform supervised treadmill-based high-intensity interval training 3 times per week.
Each session includes 10 minutes warm-up, 4 intervals of 4 minutes at 85-95% heart rate reserve, 4 minutes active recovery at 50-60% heart rate reserve, followed by 5 minutes cool-down.
Andre navne:
|
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Aktiv komparator: Moderate-Intensity Continuous Training (MICT)
Participants will perform supervised treadmill-based continuous exercise 3 sessions per week at 65-75% heart rate reserve for 30-45 minutes, with warm-up and cool-down periods.
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Participants will perform supervised treadmill-based continuous exercise 3 times per week at 65-75% heart rate reserve for 30-45 minutes, including warm-up and cool-down periods.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Left Ventricular Ejection Fraction
Tidsramme: Baseline and at 12 weeks after intervention
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Assessment of left ventricular ejection fraction using echocardiography to determine changes in cardiac function after intervention.
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Baseline and at 12 weeks after intervention
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Functional Capacity
Tidsramme: Baseline and at 12 weeks after intervention
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Functional capacity will be measured by 6-minute walk test to evaluate distance covered during exercise tolerance assessment
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Baseline and at 12 weeks after intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Lipid Profile
Tidsramme: Baseline and at 12 weeks after intervention
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Laboratory measurement of total cholesterol, LDL, HDL, and triglycerides to assess metabolic changes after exercise intervention.
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Baseline and at 12 weeks after intervention
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Arjumand Bano, MSPT, Riphah International University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Karsygdomme
- Hjerte-kar-sygdomme
- Hjertesygdomme
- Åreforkalkning
- Arterielle okklusive sygdomme
- Koronar sygdom
- Myokardieiskæmi
- Koronararteriesygdom
- Motorisk aktivitet
- Bevægelse
- Muskuloskeletale fysiologiske fænomener
- Muskuloskeletale og neurale fysiologiske fænomener
- Fysisk konditionering, menneske
- Øvelse
- Intervaltræning med høj intensitet
Andre undersøgelses-id-numre
- REC/RCR & AHS/25/0320
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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