- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Muhammad Iqbal Tariq, Phd*
- Telefonnummer: 333826752
- E-post: iqbal.tariq@riphah.edu.pk
Studieorter
-
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Punjab Province
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Multan, Punjab Province, Pakistan, 60000
- Ch Pervaiz Elahi institute of cardiology Multan.
-
Kontakt:
- Arjumand Bano, MS-CPPT
- Telefonnummer: 03059551883
- E-post: arjumand.bano@riphah.edu.pk
-
Huvudutredare:
- ALISHBA JAVED, MS-CPPT
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
Andra namn:
|
|
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.
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Left Ventricular Ejection Fraction
Tidsram: Baseline and at 12 weeks after intervention
|
Assessment of left ventricular ejection fraction using echocardiography to determine changes in cardiac function after intervention.
|
Baseline and at 12 weeks after intervention
|
|
Functional Capacity
Tidsram: Baseline and at 12 weeks after intervention
|
Functional capacity will be measured by 6-minute walk test to evaluate distance covered during exercise tolerance assessment
|
Baseline and at 12 weeks after intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Lipid Profile
Tidsram: Baseline and at 12 weeks after intervention
|
Laboratory measurement of total cholesterol, LDL, HDL, and triglycerides to assess metabolic changes after exercise intervention.
|
Baseline and at 12 weeks after intervention
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Arjumand Bano, MSPT, Riphah International University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Hjärtsjukdom
- Arterioskleros
- Arteriella ocklusiva sjukdomar
- Kranskärlssjukdom
- Myokardischemi
- Kranskärlssjukdom
- Motorisk aktivitet
- Rörelse
- Muskuloskeletala fysiologiska fenomen
- Muskuloskeletala och neurala fysiologiska fenomen
- Fysisk konditionering, mänsklig
- Utöva
- Högintensiv intervallträning
Andra studie-ID-nummer
- REC/RCR & AHS/25/0320
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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