Life sciences · Interventional Study
ClinicalTrials.gov · November 9, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07925515). This is a study registration, not published results. Lead sponsor: Universidad Internacional Isabel I de Castilla. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 36 participants (ESTIMATED). Conditions: Heart Failure Reduced Ejection Fraction. Interventions: BEHAVIORAL: HIIT + Strength Training; BEHAVIORAL: MICT + Strength Training. Primary outcome measures: Recruitment Rate , From the start of recruitment to the end of the first 9 months of recruitment.; Acceptance of Randomisation , From screening and referral throughout the recruitment period.; Participant Retention , At the end of the 12-week intervention.; Adherence to Prescribed Exercise Sessions , Throughout the 12-week intervention.; Fidelity to the Assigned HIIT Intervention , Throughout the 12-week intervention.; Completeness of Post-Intervention MLHFQ Data , At the end of the 12-week intervention.; Exercise-Related Adverse Events , Throughout the 12-week intervention and the study period in which exercise-related adverse events are monitored.. Brief summary: Heart failure is associated with impaired health-related quality of life and reduced exercise capacity. Women remain under-represented in cardiac rehabilitation research, and evidence comparing high-intensity interval training (HIIT) with moderate-intensity continuous training (MICT) in women with heart failure is limited. HIIT-WHEF is a prospective, single-centre, randomised pilot feasibility trial involving 36 women aged 18 years or older with heart failure and a left ventricular ejection fraction below 50%. Participants will be randomly allocated in a 1:1 ratio to a 12-week supervised cardiac rehabilitation programme incorporating either HIIT or MICT. Both groups will also undertake individualised resistance training. The primary objectives are to assess the feasibility and safety of conducting the randomised trial, including recruitment, acceptance, retention, adherence, intervention fidelity, completeness of outcome data and exercise-related adverse events. Health-related quality of life, assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ), is the key clinical outcome of interest. Peak oxygen uptake, left ventricular ejection fraction and biomarkers will be assessed as exploratory clinical outcomes. The study is designed to inform the planning of a future adequately powered confirmatory trial. It is not intended to establish definitive evidence of the superiority of HIIT over MICT.