Cardiac Rehabilitation Early after Sternotomy Using New Assistive VR-Enhanced Robotic Exoskeleton—Study Protocol for a Randomised Controlled Trial

(1) Background and objective: Cardiac rehabilitation (CR) means delivering health education by structured exercises with the means of risk reduction, in a cost-effective manner. Well-conducted CR improves functional capacity, decreases re-hospitalization, and reduces mortality up to 25%. We bring to attention the protocol of a randomised control trial with the aim of validating the prototype of an assistive upper-body robotic exoskeleton system enhanced with a non-immersive virtual reality exergame (CardioVR-ReTone) in patients who undergone cardiac surgery. (2) Methods: Description of the CardioVR-ReTone system and the technical specification, followed by the group selection, randomization and evaluated variables. (3) Expected results: The primary outcome measurement is the modification of life quality at the end of the CR exercise training program. Secondary outcomes will encompass measurements of sternal stability, muscular activity, cardiac response to exercise, pain level and compliance/adherence to CR. (4) Conclusions: Implementing these novel features of the CardioVR-ReTone system, addressability, and efficacy of CR, so problematic in certain situations and especially in cardiac surgery, will be greatly facilitated, being independent of the skills and availability of the rehabilitation therapist.

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Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design—a study protocol

BMJ Open ◽

10.1136/bmjopen-2019-035787 ◽

2019 ◽

Vol 9 (12) ◽

pp. e035787

Author(s):

Dumbor Ngaage ◽

Natasha Mitchell ◽

Alexandra Dean ◽

Claire Hirst ◽

Enoch Akowuah ◽

...

Keyword(s):

Cardiac Surgery ◽

Cardiac Rehabilitation ◽

Hospital Discharge ◽

Controlled Trial ◽

Qualitative Interviews ◽

Median Sternotomy ◽

Retention Rates ◽

Upper Body ◽

Feasibility Trial ◽

Randomised Controlled

IntroductionFollowing cardiac surgery, patients currently attend an outpatient review 6 weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from 8 weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration. However, current guidelines for activity and exercise after median sternotomy have been described as restrictive, anecdotal and increasingly at odds with modern clinical guidance for CR. This study aims to examine the feasibility of bringing forward outpatient review and starting CR earlier.Methods and analysesThis is a multicentre, randomised controlled, open feasibility trial comparing postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control arm) versus, postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention arm). The study aims to recruit 100 eligible patients, aged 18–80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres. Feasibility will be measured by consent, recruitment, retention rates and attendance at appointments and CR sessions. Qualitative interviews with trial participants and staff will explore issues around study processes and acceptability of the intervention and the findings integrated with the feasibility trial outcomes to inform the design of a future full-scale randomised controlled trial.Ethics and disseminationEthics approval was granted by East Midlands—Derby Research Ethics Committee on 10 January 2019. The findings will be presented at relevant conferences disseminated via peer-reviewed research publications, and to relevant stakeholders.Trial registration numberISRCTN80441309

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Effect of a personalised mHealth home-based training application on physical activity levels during and after centre-based cardiac rehabilitation: rationale and design of the Cardiac RehApp randomised control trial

BMJ Open Sport & Exercise Medicine ◽

10.1136/bmjsem-2021-001159 ◽

2021 ◽

Vol 7 (3) ◽

pp. e001159

Author(s):

Thijs Vonk ◽

Esmee A Bakker ◽

Erwin S Zegers ◽

Maria T E Hopman ◽

Thijs M H Eijsvogels

Keyword(s):

Physical Activity ◽

Cardiac Rehabilitation ◽

Controlled Trial ◽

Habitual Physical Activity ◽

Added Value ◽

Randomised Control Trial ◽

Secondary Outcome ◽

Activity Levels ◽

Home Based ◽

Physical Activity Levels

Many patients lapse into a physically inactive lifestyle within months after cardiac rehabilitation (CR) programme completion. A mobile-health (mHealth) home-based training application can be used to intensify and/or prolong the CR programme to induce long-lasting improvements of habitual physical activity levels. This study will assess the effect of an additional home-based training module during CR and post-CR on habitual physical activity levels among coronary artery disease patients. A total of 132 patients (>18 years old) will be recruited in an 18-week randomised controlled trial with four arms: (1) 6 weeks centre-based CR (ie, standard care), (2) 6 weeks combined centre-based+mHealth home-based CR, (3) 6 weeks centre-based CR followed by 12 weeks mHealth home-based CR, (4) 6 weeks combined centre-based+mHealth home-based CR followed by 12 weeks mHealth home-based CR. The intervention groups will receive a daily and personalised exercise training using a smartphone application (Virtual Training) in addition to and/or as extension of the centre-based CR programme. The participants will be assessed prior to the centre-based CR programme, after completion of the 6-week CR programme and after the 12 weeks extension. Primary outcome will be objectively measured habitual physical activity levels expressed as moderate to vigorous intensity activities (min/week). Secondary outcome parameters include sedentary behaviour, physical fitness (estimated VO2max), handgrip strength, cardiovascular risk profile, quality of life and cardiac anxiety scores. The findings of the Cardiac RehApp study will provide insight into the added value of a personalised mHealth home-based training application on physical activity levels during and after centre-based CR. Trial registration number: NL72182.091.019.

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Goal Attainment and Treatment Compliance in a Cognitive-Behavioral Telephone Intervention for Family Caregivers of Persons with Dementia

GeroPsych ◽

10.1024/1662-9647/a000043 ◽

2011 ◽

Vol 24 (3) ◽

pp. 115-125 ◽

Cited By ~ 18

Author(s):

Gabriele Wilz ◽

Denise Schinköthe ◽

Renate Soellner

Keyword(s):

Family Caregivers ◽

Mentally Ill ◽

Goal Attainment ◽

Outcome Measurement ◽

Controlled Trial ◽

Treatment Success ◽

Treatment Compliance ◽

Control Group ◽

Telephone Intervention ◽

Effective Interventions

Introduction: The evaluation of effective interventions is still needed to prevent family caregivers of persons with dementia from becoming physically or mentally ill. However, in most existing intervention studies, primary outcomes are not well matched to the treatment goals. Method: A randomized controlled trial (N = 229) was conducted to compare a treatment group (CBT), a treated control group, and an untreated control group. In theses analyses we focused on the primary outcome measurement (GAS) as a perceived treatment success as well as treatment compliance and participants’ evaluation. Results: Results showed that 30.1% achieved complete goal attainment, 39.8% partial goal attainment, and 24.1% declared no change (overachievement 2.4%; deterioration 3.6%). Discussion: The intervention can be considered to have been successful.

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