High-Intensity Interval Versus Aerobic Training for Patient-Reported Outcomes in Women With Heart Failure.
NCT07925515, Not applicable, Not yet recruiting, Universidad Internacional Isabel I de Castilla
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | High-Intensity Interval Versus Aerobic Training for Patient-Reported Outcomes in Women With Heart Failure. | ClinicalTrials.gov |
| NCT number | NCT07925515 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 36 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Universidad Internacional Isabel I de Castilla | ClinicalTrials.gov |
| Conditions | Heart Failure Reduced Ejection Fraction | ClinicalTrials.gov |
| Interventions | HIIT + Strength Training, MICT + Strength Training | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Recruitment Rate | From the start of recruitment to the end of the first 9 months of recruitment. | Number of participants randomised per month during the first nine months of recruitment. Feasibility will be classified as green if at least 2 participants per month are randomised, amber if 1 to less than 2 participants per month are randomised, and red if fewer than 1 participant per month is randomised. | ClinicalTrials.gov |
| Primary | Acceptance of Randomisation | From screening and referral throughout the recruitment period. | Proportion of eligible women referred for cardiac rehabilitation who agree to randomisation. Green: at least 50%; amber: 30% to less than 50%; red: less than 30%. | ClinicalTrials.gov |
| Primary | Participant Retention | At the end of the 12-week intervention. | Proportion of randomised participants with a post-intervention assessment. Green: at least 85%; amber: 70% to less than 85%; red: less than 70%. | ClinicalTrials.gov |
| Primary | Adherence to Prescribed Exercise Sessions | Throughout the 12-week intervention. | Proportion of prescribed exercise sessions attended by participants who complete the programme. Green: at least 80%; amber: 65% to less than 80%; red: less than 65%. | ClinicalTrials.gov |
| Primary | Fidelity to the Assigned HIIT Intervention | Throughout the 12-week intervention. | Proportion of HIIT sessions in which at least four intervals are completed above the second ventilatory threshold. Green: at least 75%; amber: 60% to less than 75%; red: less than 60%. | ClinicalTrials.gov |
| Primary | Completeness of Post-Intervention MLHFQ Data | At the end of the 12-week intervention. | Proportion of randomised participants with a completed Minnesota Living with Heart Failure Questionnaire (MLHFQ) at post-intervention assessment. Green: at least 90%; amber: 75% to less than 90%; red: less than 75%. | ClinicalTrials.gov |
| Primary | Exercise-Related Adverse Events | Throughout the 12-week intervention and the study period in which exercise-related adverse events are monitored. | Frequency and nature of adverse events related to exercise, including serious adverse events and events requiring modification of exercise prescription. Feasibility criteria are green if no serious exercise-related adverse event occurs; amber if non-serious events require modification of the prescription in more than 20% of cases; and red if any serious adverse event attributable to exercise occurs. | ClinicalTrials.gov |
| Secondary | Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score | Baseline and 12 weeks. | Between-group difference in the post-intervention MLHFQ total score, adjusted for baseline score using analysis of covariance (ANCOVA). The MLHFQ ranges from 0 to 105, with higher scores indicating worse health-related quality of life. The baseline-to-post-intervention change will also be reported. This is an exploratory clinical outcome in the pilot trial and will not be used to establish confirmatory superiority. | ClinicalTrials.gov |
| Secondary | Change in Peak Oxygen Consumption (VO2peak) | Baseline and at 12 weeks | Between-group difference in peak oxygen uptake measured during cardiopulmonary exercise testing, adjusted for baseline VO2peak. VO2peak will be expressed in mL/kg/min and defined as the highest oxygen uptake achieved during the final 30 seconds of exercise. | ClinicalTrials.gov |
| Secondary | Change in Left Ventricular Ejection Fraction (LVEF) | Baseline and at 12 weeks | Between-group difference in left ventricular ejection fraction measured by echocardiography, adjusted for baseline LVEF. Results will be expressed as percentage points. | ClinicalTrials.gov |
| Secondary | Changes in NT-proBNP, High-Sensitivity C-Reactive Protein and CA125 | Baseline and at 12 weeks | Changes in circulating NT-proBNP, high-sensitivity C-reactive protein (hs-CRP) and CA125 concentrations from baseline to post-intervention. Between-group comparisons will be exploratory and adjusted for baseline values where appropriate. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)