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Feasibility and Preliminary Effects of the BESMILE-HF Program on Chronic Heart Failure Patients: A Pilot Randomized Controlled Trial.

ABSTRACT: Aims: The Baduanjin Eight-Silken-Movements wIth Self-Efficacy building for Heart Failure (BESMILE-HF) program is a contextually adapted cardiac rehabilitation program. It uses a traditional Chinese exercise, Baduanjin, to solve the unmet demand of exercise-based cardiac rehabilitation programs due to their scarcity and unaffordability in China. This pilot study assesses BESMILE-HF's feasibility and preliminary effects. Methods: Eighteen patients with chronic heart failure were included: 8 in a BESMILE-HF group (age: 67 ± 5 years, EF: 40.4 ± 13.6%) and 10 in a control group (age: 70 ± 13 years, EF: 42.9 ± 12.5%). Both received the usual medications, with the intervention group receiving additionally the BESMILE-HF program for 6 weeks. Feasibility was explored by participants' involvement in the intended intervention. Clinical outcome assessments were conducted at baseline and post-intervention, while adverse events were captured throughout the study period. Results: The BESMILE-HF program was well-received by patients, and adherence to the intervention was good. The intervention group completed all required home exercises and total home-practice time was correlated with baseline self-efficacy (r = 0.831, p = 0.011). Moreover, after 6 weeks, self-efficacy increased in the BESMILE-HF group (p = 0.028) and the change was higher than in the control [mean difference (MD): 3.2; 95% confidence interval (CI) 0.6-5.9, p = 0.004]. For the exercise capacity, the control group demonstrated a significant decline in peak oxygen consumption (p =0.018) whereas, the BESMILE-HF group maintained their exercise capacity (p = 0.063). Although the between-group difference was not statistically significance, there was clear clinical improvement in the BESMILE-HF group (1.5 mL/kg/min, 95% CI, -0.3 to 3.2 vs. minimal clinically important difference of 1 mL/kg/min). Throughout the study period, no adverse events related to the intervention were captured. Conclusions: BESMILE-HF is feasible for patients with chronic heart failure in Chinese settings. A larger sample size and a longer follow-up period is needed to confirm its benefit on clinical outcomes. Clinical Trial Registration:ClinicalTrials.gov: NCT03180320.

SUBMITTER: Chen X

PROVIDER: S-EPMC8353081 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesTo test the hypothesis that (1) older patients with heart failure (HF) can tolerate COMBined moderate-intensity aerobic and resistance training (COMBO), and (2) 4 weeks of Peripheral Remodeling through Intermittent Muscular Exercise (PRIME) before 4 weeks of COMBO will improve aerobic capacity and muscle strength to a greater extent than 8 weeks of COMBO.DesignProspective randomized parallel open-label blinded end point.SettingSingle-site Australian metropolitan hospital.ParticipantsNineteen adults (72.8 ± 8.4 years of age) with heart failure with reduced ejection fraction (HFrEF).InterventionParticipants were randomized to 4 weeks of PRIME or COMBO (phase 1). All participants subsequently completed 4 weeks of COMBO (phase 2). Sessions were twice a week for 60 minutes. PRIME is a low-mass, high-repetition regime (40% one-repetition maximum [1RM], eight strength exercises, 5 minutes each). COMBO training involved combined aerobic (40%-60% of peak aerobic capacity [VO2peak ], up to 20 minutes) and resistance training (50-70% 1RM, eight exercises, two sets of 10 repetitions).MeasurementsWe measured VO2peak , VO2 at anaerobic threshold (AT), and muscle voluntary contraction (MVC).ResultsThe PRIME group significantly increased VO2peak after 8 weeks (2.4 mL/kg/min; 95% confidence interval [CI] = .7-4.1; P = .004), whereas the COMBO group showed minimal change (.2; 95% CI -1.5 to 1.8). This produced a large between-group effect size of 1.0. VO2 at AT increased in the PRIME group (1.6 mL/kg/min; 95% CI .0-3.2) but not in the COMBO group (-1.2; 95% CI -2.9 to .4), producing a large between-group effect size. Total MVC increased significantly in both groups in comparison with baseline; however, the change was larger in the COMBO group (effect size = .6).ConclusionTraditional exercise approaches (COMBO) and PRIME improved strength. Only PRIME training produced statistically and clinically significant improvements to aerobic capacity. Taken together, these findings support the hypothesis that PRIME may have potential advantages for older patients with HFrEF and could be a possible alternative exercise modality.

Project description:Guidelines recommend that exercise training be considered for medically stable outpatients with heart failure. Previous studies have not had adequate statistical power to measure the effects of exercise training on clinical outcomes.To test the efficacy and safety of exercise training among patients with heart failure.Multicenter, randomized controlled trial of 2331 medically stable outpatients with heart failure and reduced ejection fraction. Participants in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) were randomized from April 2003 through February 2007 at 82 centers within the United States, Canada, and France; median follow-up was 30 months.Usual care plus aerobic exercise training, consisting of 36 supervised sessions followed by home-based training, or usual care alone.Composite primary end point of all-cause mortality or hospitalization and prespecified secondary end points of all-cause mortality, cardiovascular mortality or cardiovascular hospitalization, and cardiovascular mortality or heart failure hospitalization.The median age was 59 years, 28% were women, and 37% had New York Heart Association class III or IV symptoms. Heart failure etiology was ischemic in 51%, and median left ventricular ejection fraction was 25%. Exercise adherence decreased from a median of 95 minutes per week during months 4 through 6 of follow-up to 74 minutes per week during months 10 through 12. A total of 759 patients (65%) in the exercise training group died or were hospitalized compared with 796 patients (68%) in the usual care group (hazard ratio [HR], 0.93 [95% confidence interval {CI}, 0.84-1.02]; P = .13). There were nonsignificant reductions in the exercise training group for mortality (189 patients [16%] in the exercise training group vs 198 patients [17%] in the usual care group; HR, 0.96 [95% CI, 0.79-1.17]; P = .70), cardiovascular mortality or cardiovascular hospitalization (632 [55%] in the exercise training group vs 677 [58%] in the usual care group; HR, 0.92 [95% CI, 0.83-1.03]; P = .14), and cardiovascular mortality or heart failure hospitalization (344 [30%] in the exercise training group vs 393 [34%] in the usual care group; HR, 0.87 [95% CI, 0.75-1.00]; P = .06). In prespecified supplementary analyses adjusting for highly prognostic baseline characteristics, the HRs were 0.89 (95% CI, 0.81-0.99; P = .03) for all-cause mortality or hospitalization, 0.91 (95% CI, 0.82-1.01; P = .09) for cardiovascular mortality or cardiovascular hospitalization, and 0.85 (95% CI, 0.74-0.99; P = .03) for cardiovascular mortality or heart failure hospitalization. Other adverse events were similar between the groups.In the protocol-specified primary analysis, exercise training resulted in nonsignificant reductions in the primary end point of all-cause mortality or hospitalization and in key secondary clinical end points. After adjustment for highly prognostic predictors of the primary end point, exercise training was associated with modest significant reductions for both all-cause mortality or hospitalization and cardiovascular mortality or heart failure hospitalization.clinicaltrials.gov Identifier: NCT00047437.

Project description:BackgroundAdvanced heart failure (HF) is characterized by high morbidity and mortality. Conventional therapy may not sufficiently reduce patient suffering and maximize quality of life.ObjectivesThe authors investigated whether an interdisciplinary palliative care intervention in addition to evidence-based HF care improves certain outcomes.MethodsThe authors randomized 150 patients with advanced HF between August 15, 2012, and June 25, 2015, to usual care (UC) (n = 75) or UC plus a palliative care intervention (UC + PAL) (n = 75) at a single center. Primary endpoints were 2 quality-of-life measurements, the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary and the Functional Assessment of Chronic Illness Therapy-Palliative Care scale (FACIT-Pal), assessed at 6 months. Secondary endpoints included assessments of depression and anxiety (measured via the Hospital Anxiety and Depression Scale [HADS]), spiritual well-being (measured via the FACIT-Spiritual Well-Being scale [FACIT-Sp]), hospitalizations, and mortality.ResultsPatients randomized to UC + PAL versus UC alone had clinically significant incremental improvement in KCCQ and FACIT-Pal scores from randomization to 6 months (KCCQ difference = 9.49 points, 95% confidence interval [CI]: 0.94 to 18.05, p = 0.030; FACIT-Pal difference = 11.77 points, 95% CI: 0.84 to 22.71, p = 0.035). Depression improved in UC + PAL patients (HADS-depression difference = -1.94 points; p = 0.020) versus UC-alone patients, with similar findings for anxiety (HADS-anxiety difference = -1.83 points; p = 0.048). Spiritual well-being was improved in UC + PAL versus UC-alone patients (FACIT-Sp difference = 3.98 points; p = 0.027). Randomization to UC + PAL did not affect rehospitalization or mortality.ConclusionsAn interdisciplinary palliative care intervention in advanced HF patients showed consistently greater benefits in quality of life, anxiety, depression, and spiritual well-being compared with UC alone. (Palliative Care in Heart Failure [PAL-HF]; NCT01589601).

Project description:Findings from previous studies of the effects of exercise training on patient-reported health status have been inconsistent.To test the effects of exercise training on health status among patients with heart failure.Multicenter, randomized controlled trial among 2331 medically stable outpatients with heart failure with left ventricular ejection fraction of 35% or less. Patients were randomized from April 2003 through February 2007.Usual care plus aerobic exercise training (n = 1172), consisting of 36 supervised sessions followed by home-based training, vs usual care alone (n = 1159). Randomization was stratified by heart failure etiology, which was a covariate in all models.Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary scale and key subscales at baseline, every 3 months for 12 months, and annually thereafter for up to 4 years. The KCCQ is scored from 0 to 100 with higher scores corresponding to better health status. Treatment group effects were estimated using linear mixed models according to the intention-to-treat principle.Median follow-up was 2.5 years. At 3 months, usual care plus exercise training led to greater improvement in the KCCQ overall summary score (mean, 5.21; 95% confidence interval, 4.42 to 6.00) compared with usual care alone (3.28; 95% confidence interval, 2.48 to 4.09). The additional 1.93-point increase (95% confidence interval, 0.84 to 3.01) in the exercise training group was statistically significant (P < .001). After 3 months, there were no further significant changes in KCCQ score for either group (P = .85 for the difference between slopes), resulting in a sustained, greater improvement overall for the exercise group (P < .001). Results were similar on the KCCQ subscales, and no subgroup interactions were detected.Exercise training conferred modest but statistically significant improvements in self-reported health status compared with usual care without training. Improvements occurred early and persisted over time.clinicaltrials.gov Identifier: NCT00047437.

Project description:BackgroundHeart failure (HF) is a burdensome condition and a leading cause of 30-day hospital readmissions in the United States. Clinical and social factors are key drivers of hospitalization. These 2 strategies, digital platforms and home-based social needs care, have shown preliminary effectiveness in improving adherence to clinical care plans and reducing acute care use in HF. Few studies, if any, have tested combining these 2 strategies in a single intervention.ObjectiveThis study aims to perform a pilot randomized controlled trial assessing the acceptability, feasibility, and preliminary effectiveness of a 30-day digitally-enabled community health worker (CHW) intervention in HF.MethodsAdults hospitalized with a diagnosis of HF at an academic hospital were randomly assigned to receive digitally-enabled CHW care (intervention; digital platform +CHW) or CHW-enhanced usual care (control; CHW only) for 30 days after hospital discharge. Primary outcomes were feasibility (use of the platform) and acceptability (willingness to use the platform in the future). Secondary outcomes assessed preliminary effectiveness (30-day readmissions, emergency department visits, and missed clinic appointments).ResultsA total of 56 participants were randomized (control: n=31; intervention: n=25) and 47 participants (control: n=28; intervention: n=19) completed all trial activities. Intervention participants who completed trial activities wore the digital sensor on 78% of study days with mean use of 11.4 (SD 4.6) hours/day, completed symptom questionnaires on 75% of study days, used the blood pressure monitor 1.1 (SD 0.19) times/day, and used the digital weight scale 1 (SD 0.13) time/day. Of intervention participants, 100% responded very or somewhat true to the statement "If I have access to the [platform] moving forward, I will use it." Some (n=9, 47%) intervention participants indicated they required support to use the digital platform. A total of 19 (100%) intervention participants and 25 (89%) control participants had ≥5 CHW interactions during the 30-day study period. All intervention (n=19, 100%) and control (n=26, 93%) participants who completed trial activities indicated their CHW interactions were "very satisfying." In the full sample (N=56), fewer participants in the intervention group were readmitted 30 days after hospital discharge compared to the control group (n=3, 12% vs n=8, 26%; P=.12). Both arms had similar rates of missed clinic appointments and emergency department visits.ConclusionsThis pilot trial of a digitally-enabled CHW intervention for HF demonstrated feasibility, acceptability, and a clinically relevant reduction in 30-day readmissions among participants who received the intervention. Additional investigation is needed in a larger trial to determine the effect of this intervention on HF home management and clinical outcomes.Trial registrationClinicaltrials.gov NCT05130008; https://clinicaltrials.gov/study/NCT05130008.International registered report identifier (irrid)RR2-10.2196/55687.

Project description:BackgroundPatients with chronic conditions, such as heart failure, swim regularly and most rehabilitation exercises are conducted in warm hydrotherapy pools. However, little is known about the acute effects of warm water immersion (WWI) on cardiac haemodynamics in patients with chronic heart failure (CHF).MethodsSeventeen patients with CHF (NYHA I and II; mean age 67 years, 88% male, mean left ventricular ejection fraction 33%) and 10 age-matched normal subjects were immersed up to the neck in a hydrotherapy pool (33-35 °C). Cardiac haemodynamics were measured non-invasively, and echocardiography was performed at baseline, during WWI, 3 min after kicking in the supine position and after emerging.ResultsIn patients with CHF, compared to baseline, WWI immediately increased stroke volume (SV, mean ± standard deviation; from 65 ± 21 to 82 ± 22 mL, p < 0.001), cardiac output (CO, from 4.4 ± 1.4 to 5.7 ± 1.6 L/min, p < 0.001) and cardiac index (CI, from 2.3 ± 0.6 to 2.9 ± 0.70 L/min/m², p < 0.001) with decreased systemic vascular resistance (from 1881 ± 582 to 1258 ± 332 dynes/s/cm5, p < 0.001) and systolic blood pressure (132 ± 21 to 115 ± 23 mmHg, p < 0.001). The haemodynamic changes persisted for 15 min of WWI. In normal subjects, compared to baseline, WWI increased SV (from 68 ± 11 to 80 ± 18 mL, p < 0.001), CO (from 5.1 ± 1.9 to 5.7 ± 1.8 L/min, p < 0.001) and CI (from 2.7 ± 0.9 to 2.9 ± 1.0 L/min/m², p < 0.001).In patients with CHF, compared to baseline, WWI caused an increase in left atrial volume (from 57 ± 44 to 72 ± 46 mL, p = 0.04), without any changes in left ventricular size or function or amino terminal pro B-type natriuretic peptide.ConclusionsIn patients with CHF, WWI causes an acute increase in cardiac output and a fall in systemic vascular resistance.Clinical trial registrationClinicalTrials.gov (Identifier: NCT02949544) https://clinicaltrials.gov/ct2/show/NCT02949544?cond=NCT02949544&rank=1 .

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Feasibility and Preliminary Effects of the BESMILE-HF Program on Chronic Heart Failure Patients: A Pilot Randomized Controlled Trial.

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