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ENDO-RNCT06788275

Aerobic Exercise-induced Effect on Cardiorespiratory Fitness, Endothelial Function, and Brain-derived Neurotrophic Factor in Patients With Ischaemic Heart Disease

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later, primary endpoint(s) modified, and 1 more.

See at-risk trials from Instituto de Investigación Sanitaria y Biomédica de Alicante

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 2027 to May 2028 Show 9 more changesShow less
    • Primary endpoint(s) modified
    • Eligibility criteria expanded, about 40 words
    • Enrollment reduced: 132 → 111 participants
    • Study completion pushed from Nov 2027 to Nov 2028
    • Interventions modified
    • Secondary endpoints: 12 to 15
    • Site details revised at 1 of 2 sites
    • Publications: details revised at 1 of 1 entry
    • Study title expanded, about 6 words
  2. Secondary endpoints: 10 to 12
    • Site details revised at 1 of 2 sites
    v3
  3. Primary completion date: Jan 2025 to May 2027
    • Site details revised at 1 of 2 sites
    v2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change from baseline in endothelial function at 8 weeks
Timeframe: 8 weeks
Change from baseline in endothelial function at 15 weeks
Timeframe: 15 weeks
Change from baseline in VO2 peak at 8 weeks
Timeframe: 8 weeks
Change from baseline in VO2 peak at 15 weeks
Timeframe: 15 weeks
Change from baseline in resting serum BDNF concentration at 8 weeks
Timeframe: 8 weeks
Change from baseline in resting serum BDNF concentration at 15 weeks
Timeframe: 15 weeks
Change from baseline in exercise-induced effect on serum BDNF at 8 weeks
Timeframe: 8 weeks
Change from baseline in exercise-induced effect on serum BDNF at 15 weeks
Timeframe: 15 weeks

Secondary (15)

Change from baseline in endothelial-independent dilation at 8 and 15 weeks
Change from baseline in pulmonary function at 8 and 15 weeks
Change from baseline in resting cardiopulmonary parameters at 8 and 15 weeks
Change from baseline in cardiopulmonary parameters at first and second ventilatory thresholds at 8 and 15 weeks
Change from baseline in peak cardiopulmonary parameters at 8 and 15 weeks
Show 10 moreShow less
Change from baseline in cardiopulmonary variables measured during the recovery at 8 and 15 weeks
Change from baseline in ventilatory efficiency at 8 and 15 weeks
Change from baseline in MacNew domains at 8 and 15 weeks
Change from baseline in body composition at 8 and 15 weeks
Change from baseline in resting heart rate variability (HRV) at 8 and 15 weeks
Change from baseline in echocardiographic variables at 8 and 15 weeks
Change from baseline in blood analysis variables at 15 weeks.
Change from baseline in ability to inhibit cognitive interference at 8 and 15 weeks
Change from baseline in verbal memory performance at 15 weeks
Change from baseline in visuospatial working memory performance at 15 weeks

Arms and interventions

Moderate-intensity continuous training (MICT) groupExperimental

Continuous exercise training on a cycle ergometer

Short high-intensity interval training (HIIT) groupExperimental

High-intensity interval exercise performed on a cycle ergometer

Long high-intensity interval training (HIIT) groupExperimental

High-intensity interval exercise performed on a cycle ergometer

Behavioral: Aerobic exercise (MICT), Aerobic exercise (Short HIIT), Aerobic exercise (Long HIIT)

Sites

2 sites in 1 country