scholarly journals Ecologically optimizing exercise maintenance in men and women post-cardiac rehabilitation: Protocol for a randomized controlled trial of efficacy with economics (ECO-PCR)

2016 ◽  
Vol 50 ◽  
pp. 116-123 ◽  
Author(s):  
Robert Reid ◽  
Chris M. Blanchard ◽  
Evyanne Wooding ◽  
Jennifer Harris ◽  
Murray Krahn ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Controlled Trial ◽  
Men And Women ◽  
Rehabilitation Protocol ◽  
Exercise Maintenance ◽  
Randomized Controlled

scholarly journals Efficacy of repetitive transcranial magnetic stimulation combined with visual scanning treatment on cognitive and behavioral symptoms of left hemispatial neglect in right hemispheric stroke patients: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Francesco Di Gregorio ◽  
Fabio La Porta ◽  
Emanuela Casanova ◽  
Elisabetta Magni ◽  
Roberta Bonora ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Transcranial Magnetic Stimulation ◽  
Magnetic Stimulation ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Controlled Trial ◽  
Hemispatial Neglect ◽  
Visual Scanning ◽  
Stroke Patients ◽  
Rehabilitation Protocol ◽  
Randomized Controlled

Abstract Background Left hemispatial neglect (LHN) is a neuropsychological syndrome often associated with right hemispheric stroke. Patients with LHN have difficulties in attending, responding, and consciously representing the right side of space. Various rehabilitation protocols have been proposed to reduce clinical symptoms related to LHN, using cognitive treatments, or on non-invasive brain stimulation. However, evidence of their benefit is still lacking; in particular, only a few studies focused on the efficacy of combining different approaches in the same patient. Methods In the present study, we present the SMART ATLAS trial (Stimolazione MAgnetica Ripetitiva Transcranica nell’ATtenzione LAteralizzata dopo Stroke), a multicenter, randomized, controlled trial with pre-test (baseline), post-test, and 12 weeks follow-up assessments based on a novel rehabilitation protocol based on the combination of brain stimulation and standard cognitive treatment. In particular, we will compare the efficacy of inhibitory repetitive-transcranial magnetic stimulation (r-TMS), applied over the left intact parietal cortex of LHN patients, followed by visual scanning treatment, in comparison with a placebo stimulation (SHAM control) followed by the same visual scanning treatment, on visuospatial symptoms and neurophysiological parameters of LHN in a population of stroke patients. Discussion Our trial results may provide scientific evidence of a new, relatively low-cost rehabilitation protocol for the treatment of LHN. Trial registration ClinicalTrials.gov NCT04080999. Registered on September 2019.

OUTCOMES FROM A RANDOMIZED CONTROLLED TRIAL OF A GROUP INTERVENTION FOR HIV POSITIVE MEN AND WOMEN COPING WITH AIDS-RELATED LOSS AND BEREAVEMENT

Death Studies ◽  
2004 ◽  
Vol 28 (3) ◽  
pp. 187-209 ◽  
Author(s):  
KATHLEEN J. SIKKEMA ◽  
NATHAN B. HANSEN ◽  
ARLENE KOCHMAN ◽  
DAVID C. TATE ◽  
WAYNE DIFRANCEISCO
Keyword(s):  
Randomized Controlled Trial ◽  
Group Intervention ◽  
Controlled Trial ◽  
Hiv Positive ◽  
Men And Women ◽  
Randomized Controlled ◽  
Hiv Positive Men

scholarly journals Smartphone Cardiac Rehabilitation, Assisted Self-Management Versus Usual Care: Protocol for a Multicenter Randomized Controlled Trial to Compare Effects and Costs Among People With Coronary Heart Disease (Preprint)

2019 ◽  
Author(s):  
Jonathan Charles Rawstorn ◽  
Kylie Ball ◽  
Brian Oldenburg ◽  
Clara K Chow ◽  
Sarah A McNaughton ◽  
...  
Keyword(s):  
Health Care ◽  
Coronary Heart Disease ◽  
Randomized Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Management ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Delivery Models

BACKGROUND Alternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistent low utilization. Models utilizing contemporary digital technologies could significantly improve reach and fidelity as complementary alternatives to traditional center-based programs. OBJECTIVE The aim of this study is to compare the effects and costs of the innovative <i>Smartphone Cardiac Rehabilitation, Assisted self-Management</i> (SCRAM) intervention with usual care CR. METHODS In this investigator-, assessor-, and statistician-blinded parallel 2-arm randomized controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from 3 hospitals in metropolitan and regional Victoria, Australia. Participants are randomized (1:1) to receive advice to engage with usual care CR or the SCRAM intervention. SCRAM is a 24-week dual-phase intervention that includes 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists, which is followed by 12 weeks of data-driven nonreal-time remote coaching via telephone. Both intervention phases include evidence- and theory-based multifactorial behavior change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 weeks, and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviors, health-related quality of life, and adverse events. Economic and process evaluations will determine cost-effectiveness and participant perceptions of the treatment arms, respectively. RESULTS The trial was funded in November 2017 and received ethical approval in June 2018. Recruitment began in November 2018. As of September 2019, 54 participants have been randomized into the trial. CONCLUSIONS The innovative multiphase SCRAM intervention delivers real-time remote exercise supervision and evidence-based self-management behavioral support to participants, regardless of their geographic proximity to traditional center-based CR facilities. Our trial will provide unique and valuable information about effects of SCRAM on outcomes associated with cardiac and all-cause mortality, as well as acceptability and cost-effectiveness. These findings will be important to inform health care providers about the potential for innovative program delivery models, such as SCRAM, to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort comprising metropolitan-, regional-, and rural-dwelling participants will help to understand the role of this delivery model across health care contexts with diverse needs. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ACTRN): 12618001458224; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374508. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15022

scholarly journals Effects of individualized follow-up with a smartphone-application after cardiac rehabilitation: protocol of a randomized controlled trial

2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Pernille Lunde ◽  
Asta Bye ◽  
Astrid Bergland ◽  
Birgitta Blakstad Nilsson
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Smartphone Application ◽  
Control Group ◽  
Power Calculation ◽  
Large Sample Size ◽  
Randomized Controlled

Abstract Background Cardiac rehabilitation (CR) programs are evidence-based and widely recommended. However, benefits from CR are likely lost among individuals who discontinue their regular exercise routines and healthy habits. One possible approach to enhance adherence to lifestyle advice after completion of CR, may be individualized follow-up enabled by a smartphone application (app). Methods A protocol of a single-blinded, pragmatic randomized controlled trial. The study will take place in the eastern part of Norway, and will include heart patients who have completed CR. Participants will be recruited from two CR centers. Based on power calculation, 113 participants will be included. The intervention group will receive individualized follow-up through an app on a weekly basis throughout a year. The app will be set up with the participant’s own goals, and the follow-up will be based on these individual goals. The control group will receive usual care, including general advice regarding physical activity, exercise and diet. The participants will be assessed at baseline (at completion of CR) and 12 months after baseline. Primary outcome of the study will be peak oxygen uptake. Secondary outcomes include exercise performance, quality of life, health status, health literacy, self-perceived goal achievement, exercise habits, body weight, blood pressure as well as lipids and triglycerides. Discussion To our knowledge, this will be the first study to examine the effects of individualized follow-up with an app for one year, in patients completing CR. Hence, it is reasonable to assume that the study may be groundbreaking. Due to the large sample size and the theoretically based intervention, the study has the potential to generate new knowledge that may improve the design of future technology-based follow-up interventions of patients that have completed rehabilitation. Trial registration ClinicalTrials.gov. NCT03174106. First registration, 19/05/2017.

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