scholarly journals High-Intensity Interval Training for Heart Failure Patients With Preserved Ejection Fraction (HIT-HF)-Rational and Design of a Prospective, Randomized, Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Benedikt A. Gasser ◽  
Maria Boesing ◽  
Raphael Schoch ◽  
Stefanie Brighenti-Zogg ◽  
Julia M. Kröpfl ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Ejection Fraction ◽  
Exercise Capacity ◽  
Controlled Trial ◽  
Control Group ◽  
Preserved Ejection Fraction ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
High Intensity Interval ◽  
Disease Specific

Background: The pathophysiology of HF with preserved ejection fraction (HFpEF) has not yet been fully understood and HFpEF is often misdiagnosed. Remodeling and fibrosis stimulated by inflammation appear to be main factors for the progression of HFpEF. In contrast to patients with HF with reduced ejection fraction, medical treatment in HFpEF is limited to relieving HF symptoms. Since mortality in HFpEF patients remains unacceptably high with a 5-year survival rate of only 30%, new treatment strategies are urgently needed. Exercise seems to be a valid option. However, the optimal training regime still has to be elucidated. Therefore, the aim of the study is to investigate the effects of a high-intensity interval (HIT) training vs. a moderate continuous training (MCT) on exercise capacity and disease-specific mechanisms in a cohort of patients with HFpEF.Methods: The proposed study will be a prospective, randomized controlled trial in a primary care setting including 86 patients with stable HFpEF. Patients will undergo measurements of exercise capacity, disease-specific blood biomarkers, cardiac and arterial vessel structure and function, total hemoglobin mass, metabolic requirements, habitual physical activity, and quality of life (QoL) at baseline and follow-up. After the baseline visit, patients will be randomized to the intervention or control group. The intervention group (n = 43) will attend a supervised 12-week HIT on a bicycle ergometer combined with strength training. The control group (n = 43) will receive an isocaloric supervised MCT combined with strength training. After 12 weeks, study measurements will be repeated in all patients to quantify the effects of the intervention. In addition, telephone interviews will be performed at 6 months, 1, 2, and 3 years after the last visit to assess clinical outcomes and QoL.Discussion: We anticipate clinically significant changes in exercise capacity, expressed as VO2peak, as well as in disease-specific mechanisms following HIT compared to MCT. Moreover, the study is expected to add important knowledge on the pathophysiology of HFpEF and the clinical benefits of a training intervention as a novel treatment strategy in HFpEF patients, which may help to improve both QoL and functional status in affected patients.Trial registration:ClinicalTrials.gov, identifier: NCT03184311, Registered 9 June 2017.

scholarly journals Asthma in Adolescents: A Randomized, Controlled Trial of an Asthma Program for Adolescents and Young Adults with Severe Asthma

2002 ◽  
Vol 9 (4) ◽  
pp. 253-259 ◽  
Author(s):  
Robert L Cowie ◽  
Margot F Underwood ◽  
Cinde B Little ◽  
Ian Mitchell ◽  
Sheldon Spier ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Asthma Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Disease Specific

BACKGROUND: Asthma is common and is often poorly controlled in adolescent subjects.OBJECTIVE: To determine the impact of an age-specific asthma program on asthma control, particularly on exacerbations of asthma requiring emergency department treatment, and on the quality of life of adolescents with asthma.METHODS: The present randomized, controlled trial included patients who were 15 to 20 years of age and had visited emergency departments for management of their asthma. The interventional group attended an age-specific asthma program that included assessment, education and management by a team of asthma educators, respiratory therapists and respiratory physicians. In the control group, spirometry was performed, and the patients continued to receive usual care from their regular physicians. The outcomes were assessed by a questionnaire six months after entry into the study.RESULTS: Ninety-three subjects entered the study and were randomly assigned to the intervention or control group. Of these, only 62 patients were available for review after six months. Subjects in both the control and the intervention groups showed a marked improvement in their level of asthma control, reflected primarily by a 73% reduction in the rate of emergency department attendance for asthma. Other indexes of disease control, including disease-specific quality of life, as assessed by questionnaires, were improved. There was, however, no discernible difference between the subjects in the two groups, with the exception of an improvement in favour of the intervention group in the symptom (actual difference 0.7, P=0.048) and emotional (actual difference 0.8, P=0.028) domains of the asthma quality of life questionnaire. The overall quality of life score favoured the intervention group by a clinically relevant difference of 0.6, but this difference did not reach statistical significance (P=0.06).CONCLUSIONS: Although all subjects demonstrated a significant improvement in asthma control and quality of life, the improvement attributable to this intervention was limited to two domains in disease-specific quality of life.

scholarly journals Rapid Intervention of Chlorpromazine and Promethazine for Hibernation-Like Effect in Stroke: Rationale, Design, and Protocol for a Prospective Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Shuyu Lv ◽  
Wenbo Zhao ◽  
Gary B. Rajah ◽  
Chaitu Dandu ◽  
Lipeng Cai ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intravenous Administration ◽  
Neuroprotective Effect ◽  
Controlled Trial ◽  
Intervention Group ◽  
Intravenous Thrombolysis ◽  
Control Group ◽  
Short Treatment ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial

Background: Following an acute ischemic stroke (AIS), rapidly initiated reperfusion therapies [i. e., intravenous thrombolysis (IVT) and endovascular treatment (EVT)] demonstrate robust clinical efficacy. However, only a subset of these patients can benefit from these therapies due to their short treatment windows and potential complications. In addition, many patients despite successful reperfusion still have unfavorable outcomes. Thus, neuroprotection strategies are urgently needed for AIS patients. Chlorpromazine and promethazine (C+P) have been employed in clinical practice for antipsychotic and sedative purposes. A clinical study has also shown a neuroprotective effect of C+P on patients with cerebral hemorrhage and subarachnoid hemorrhage. The safety, feasibility, and preliminary efficacy of intravenous administration of C+P in AIS patients within 24 h of onset will be elucidated.Methods: A prospective randomized controlled trial is proposed with AIS patients. Participants will be randomly allocated to an intervention group and a control group with a 1:1 ratio (n = 30) and will be treated with standard therapies according to the current stroke guidelines. Participants allocated to the intervention group will receive intravenous administration of C+P (chlorpromazine 50 mg and promethazine 50 mg) within 24 h of symptom onset. The primary outcome is safety (mainly hypotension), while the secondary outcomes include changes in functional outcome and infarction volume.Discussions: This study on Rapid Intervention of Chlorpromazine and Promethazine for Hibernation-like Effect in Stroke (RICHES) will be the first prospective randomized controlled trial to ascertain the safety, feasibility, and preliminary efficacy of intravenous C+P as a neuroprotection strategy in AIS patients. These results will provide parameters for future studies, provide insights into treatment effects, and neuroprotection with phenothiazine in AIS.Clinical Trial Registration:www.chictr.org.cn, identifier: ChiCTR2000038727.

Early outcomes of primary total hip arthroplasty with use of a smartphone-based care platform: a prospective randomized controlled trial

2021 ◽  
Vol 103-B (7 Supple B) ◽  
pp. 91-97 ◽  
Author(s):  
David A. Crawford ◽  
Adolph V. Lombardi ◽  
Keith R. Berend ◽  
James I. Huddleston ◽  
Christopher L. Peters ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Total Hip Arthroplasty ◽  
Hip Arthroplasty ◽  
Care Management ◽  
Controlled Trial ◽  
Urgent Care ◽  
Control Group ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial

Aims The purpose of this study is to evaluate early outcomes with the use of a smartphone-based exercise and educational care management system after total hip arthroplasty (THA) and demonstrate decreased use of in-person physiotherapy (PT). Methods A multicentre, prospective randomized controlled trial was conducted to evaluate a smartphone-based care platform for primary THA. Patients randomized to the control group (198) received the institution’s standard of care. Those randomized to the treatment group (167) were provided with a smartwatch and smartphone application. PT use, THA complications, readmissions, emergency department/urgent care visits, and physician office visits were evaluated. Outcome scores include the Hip disability and Osteoarthritis Outcome Score (HOOS, JR), health-related quality-of-life EuroQol five-dimension five-level score (EQ-5D-5L), single leg stance (SLS) test, and the Timed Up and Go (TUG) test. Results The control group was significantly younger by a mean 3.0 years (SD 9.8 for control, 10.4 for treatment group; p = 0.007), but there were no significant differences between groups in BMI, sex, or preoperative diagnosis. Postoperative PT use was significantly lower in the treatment group (34%) than in the control group (55.4%; p = 0.001). There were no statistically significant differences in complications, readmissions, or outpatient visits. The 90-day outcomes showed no significant differences in mean hip flexion between controls (101° (SD 10.8)) and treatment (100° (SD 11.3); p = 0.507) groups. The HOOS, JR scores were not significantly different between control group (73 points (SD 13.8)) and treatment group (73.6 points (SD 13); p = 0.660). Mean 30-day SLS time was 22.9 seconds (SD 19.8) in the control group and 20.7 seconds (SD 19.5) in the treatment group (p = 0.342). Mean TUG time was 11.8 seconds (SD 5.1) for the control group and 11.9 (SD 5) seconds for the treatment group (p = 0.859). Conclusion The use of the smartphone care management system demonstrated similar early outcomes to those achieved using traditional care models, along with a significant decrease in PT use. Noninferiority was demonstrated with regard to complications, readmissions, and ED and urgent care visits. This technology allows patients to rehabilitate on a more flexible schedule and avoid unnecessary healthcare visits, as well as potentially reducing overall healthcare costs. Cite this article: Bone Joint J 2021;103-B(7 Supple B):91–97.

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