Trial · NCT07893184
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recruitment - Recruitment rate | Week 0 | Number of included patients within the study period (n,%) |
| Primary | Recruitment (Ineligibility rate due to CPET safety criteria | Week 0 | Number of patients withdrawn due to safety criteria (n,%) |
| Primary | Adherence - Attendance rate for physiotherapist-supervised groups sessions | Week 0-4~6 | Number of attended sessions / total number of planned sessions (n,%) |
| Primary | Adherence rate - Exercise Relative Dose Intensity ExRDI cardiorespiratory training (%) | Week 0-4~6 | ExRDI cardiorespiratory training = completed exercise dose intensity / prescribed exercise dose intensity. Interval training (CABG) • Completed = Σ (completed work-interval duration \[min\] × completed work rate \[WR\]). • Prescribed = Σ (prescribed work-interval duration \[min\] × prescribed work rate \[WR\]). Continuous training (AVR) • Completed = total completed duration \[min\] × completed work rate \[WR\]. • Prescribed = total prescribed duration \[min\] × prescribed work rate \[WR\]. ExRDI cardiorespiratory training is calculated for each participant individually, cumulative for all training sessions; and cumulative for all participants. |
| Primary | Adherence rate - EXRDI peripheral strength training (%) | Week 0-4~6 | ExRDI peripheral strength training = completed exercise dose intensity / prescribed exercise dose intensity. * Completed = completed weight \[kg\] × sets \[N\] × repetitions \[N\] per exercise. * Prescribed = prescribed weight \[kg\] × sets \[N\] × repetitions \[N\] per exercise. ExRDI peripheral strength training is calculated per participant per training session for each exercise and for all four exercises cumulative. And cumulative for all training sessions; and cumulative for all participants. |
| Primary | Adherence rate - ErXDI inspiratory strength training (%) | Week 0-4~6 | ExRDI inspiratory strength training = completed exercise dose intensity / prescribed exercise dose intensity. * Completed volume = completed resistance × sets \[N\] × repetitions \[N\]. * Prescribed volume = prescribed resistance × sets \[N\] × repetitions \[N\]. ExRDI inspiratory strength training will be calculated once weekly for each participant during the supervised training session. The weekly value will be accumulated across all supervised sessions and aggregated across participants. For unsupervised inspiratory strength training, diary entries will be reviewed with the participant during the weekly supervised session. Patients will record the number of sets and repetitions performed each day, from which the completed exercise dose intensity will be derived. Prescribed volumes will be based on the individual's target resistance, sets, and repetitions for that week. Supervised and unsupervised ExRDI values will be calculated and analyzed separately. |
| Primary | Adherence - ExRDI Physical activity and unsupervised home-based exercises (%) | Week 0-4~6 | ExRDI physical activity and unsupervised home-based exerises = completed physical activity volume / prescribed physical activity volume. * Completed volume = PAM measured activity (min/day) * Prescribed volume = goal activity (min/day) ExRDI physical activity and unsupervised home-based exercises is calculated and evaluated per participant in the week during supervised training session. And cumulative for all weeks; and cumulative for all participants. |
| Primary | Reasons for not having executed a training session as intended | Week 0-4~6 | Reasons for not having executed a training session as intended (e.g., low saturation, high blood pressure, the intended training intensity could not be sustained, tiredness, etc.) |
| Primary | Reasons for not having executed a training session as intended stratified by trainings type | Week 0-4~6 | Reasons for not having executed a training session as intended (e.g., low saturation, high blood pressure, the intended training intensity could not be sustained, tiredness, etc.) |
| Primary | Drop-out rate (%) | Week 0-4~6 | Number of participants who dropped out divided by the total number of participants |
| Primary | Reasons for drop-out | Week 0-4~6 | Reasons for drop-out |
| Primary | Acceptance - Experiences with the physical prehabilitation intervention | Evaluation (after the whole training intervention). | Patient-reported experiences with the prehabilitation program (semi-structured interviews). |
| Primary | Acceptance - Suitability of the physical prehabilitation intervention and study procedures | Evaluation (after the whole training intervention). | Patient-perceived suitability of the intervention and study procedures (semi-structured interviews). |
| Primary | Acceptance - Barriers and enablers regarding participation in the study | Evaluation (after the whole training intervention). | Patient-perceived barriers and facilitators to participation (semi-structured interviews). |
| Secondary | Safety - Serious adverse events | From baseline to three month after surgery | A serious adverse event (n, %) is any untoward medical occurrence or effect that * results in death; * is life threatening (at the time of the event); * requires hospitalization or prolongation of existing inpatients' hospitalization; * results in persistent or significant disability or incapacity; * is a congenital anomaly or birth defect; or * any other important medical event that did not result in any of the outcomes listed above due to medical or surgical intervention but could have been based upon appropriate judgement by the investigator. An elective hospital admission will not be considered as a serious adverse event. In addition, within the context of this study, events such as (near-)collapse, chest pain, palpitations, or the use of emergency medication will be classified as SAEs if they meet the criteria outlined above (e.g., leading to EHH evaluation, hospitalization, or acute medical intervention). |
| Secondary | Safety - Study related adverse events | From baseline to three month after surgery | The following events are considered potentially study-related adverse events (n,%) when occurring during or in temporal relation to the intervention: * early termination of the training, because of the occurrence of one of the subjective or objective termination criteria (as described in section 5.1) * (near-)collapse * severe muscle pain lasting \>2 days * dizziness * severe nausea * palpitations or chest pain during exertion * administration of pre-defined medication as needed (pro re nata, PRN) (e.g., Nitroglycerin) for acute symptoms arising during or immediately following the intervention. Temporal classification rule: * Events occurring during or within 1 hour after a training session are considered directly intervention-related unless proven otherwise. * Events occurring more than 1 hour after the intervention are assessed on a case-by-case basis by the responsible physician, taking into account clinical context, temporal relationship, and alternative explanations. |
| Secondary | Preliminary evaluation of changes in cardiorespiratory fitness | Baseline (Week 0) and evaluation (after the whole training intervention). | * WRpeak (W/kg) as determined by the Steep Ramp Test (SRT) * Estimated VO2max (ml/kg/min) determined by FitMáx. |
| Secondary | Preliminary evaluation of changes in peripheral muscle strength | Baseline (Week 0) and evaluation (after the whole training intervention). | -8-10-repetition maximum (8-10-RM, kg) determined indirectly via validated submaximal RM tests on leg press, chest press, leg extension, and vertical traction equipment. |
| Secondary | Preliminary evaluation of changes in inspiratory muscle strength | Baseline (Week 0) and evaluation (after the whole training intervention). | -Maximum Inspiratory Pressure (MIP) (cmH2O) |
| Secondary | Physical activity behaviour and home based exercise program | Continuously during intervention. | Physical activity is measured objectively using the ankle-worn PAM AM500 3-axis accel-erometer (min/day) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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