Trial reportBMC geriatrics2026
Frailty and functional recovery after cardiac surgery: a randomized pilot trial of extended exercise-based rehabilitation.
Trial report in BMC geriatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04636970 (Unobtrusive Technologies for Monitoring of Autonomic Nervous System Function in a Setting of Inpatient Cardiac Rehabilitation and Home Training Program in Elderly Patients With Different Frailty Stages), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Unobtrusive Technologies for Monitoring of Autonomic Nervous System Function in a Setting of Inpatient Cardiac Rehabilitation and Home Training Program in Elderly Patients With Different Frailty Stages
Who cites it
0 citing papers in PubMed.
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Authors and funding
6 authors.
Funding
Abstract
objectivesPilot branch study of the FrailHeart clinical trial aimed to assess the feasibility and preliminary performance of the Edmonton Frail Scale (EFS) for detecting changes in frailty status over a 3-month follow-up period after cardiac surgery in older adults, and to explore frailty within the context of exercise-training–based (ET) cardiac rehabilitation (CR) in order to inform the design and implementation of future definitive studies targeting frailty in this population.
methodsPatients who arrived at an inpatient CR hospital after open-heart surgery between November 19, 2020, and January 3, 2022, were invited to participate. Out of 336 assessed for eligibility, 100 patients (38 females, 62 males) met the inclusion criteria and were randomized into intervention (IG, N = 50) and control groups (CG, N = 50). All participants underwent comprehensive inpatient CR based on ET. After discharge, IG continued a 12-week home ET program while CG maintained usual physical activity. Assessment times: before randomization (admittance to CR) (V1); CR completion (V2), and three months post-CR (V3). Assessment included clinical examination: six-minute walk test (6MWT), veloergometry (peak workload (W), maximal heart rate (max.HR, beats/minute), metabolic equivalent (MET), timed up and go (TUG), frailty (EFS score/status).
resultsAs a result of inpatient-CR all measured parameters except max. HR enhanced significantly for all study participants (6MWT, TUG, EFS, W, MET (p < 0.001)). Analysis of differences between groups at V2 showed significantly better physical capacity for IG (MET, p = 0.037), without statistical significant differences in other outcomes. 58 patients attended V3 and completed the entire study (IG n = 33, CG n = 25). Only W, MET and EFS enhanced for all patients significantly (p < 0,01) without statistical differences between groups. Changes in frailty status over time (V1-V3) were statistically significant (V1-V2: IG p < 0.01; V1-V3: CG p < 0.05; V1-V3: IG p < 0.05) whereas no statistically significant between-group differences were observed (χ² p = 0.32). All IG patients were able to successfully participate in the home ET program, no AE were registered.
conclusionWithin-group analyses indicated that EFS scores changed over time, suggesting that the instrument is capable of capturing short-term variation in frailty status in this clinical context. The structured CR ET program was found to be feasible and safe in this high-risk population. Although reductions in frailty scores were observed over time within groups, between-group differences were not consistently demonstrated, and the study was not powered to establish intervention effectiveness. Future adequately powered, multi-center studies incorporating comparator instruments are needed to confirm the responsiveness of the EFS and to clarify the effects of CR and ET on frailty trajectories in this population.ClinicalTrials.gov (No. NCT04636970).
trial registrationThis study was registered at ClinicalTrials.gov (ID NCT04636970). First Posted 19/11/2020.
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