• The effect of walking on risk factors for cardiovascular disease: An updated systematic review and meta-analysis of randomised control trials

      Murtagh, E.M.; Nichols, L.; Mohammed, Mohammed A.; Holder, R.L.; Nevill, A.M.; Murphy, M.H. (2015)
      Objective To conduct a systematic review and meta-analysis of randomised control trials that examined the effect of walking on risk factors for cardiovascular disease. Methods Four electronic databases and reference lists were searched (Jan 1971–June 2012). Two authors identified randomised control trials of interventions ≥ 4 weeks in duration that included at least one group with walking as the only treatment and a no-exercise comparator group. Participants were inactive at baseline. Pooled results were reported as weighted mean treatment effects and 95% confidence intervals using a random effects model. Results 32 articles reported the effects of walking interventions on cardiovascular disease risk factors. Walking increased aerobic capacity (3.04 mL/kg/min, 95% CI 2.48 to 3.60) and reduced systolic (− 3.58 mm Hg, 95% CI − 5.19 to − 1.97) and diastolic (− 1.54 mm Hg, 95% CI − 2.83 to − 0.26) blood pressure, waist circumference (− 1.51 cm, 95% CI − 2.34 to − 0.68), weight (− 1.37 kg, 95% CI − 1.75 to − 1.00), percentage body fat (− 1.22%, 95% CI − 1.70 to − 0.73) and body mass index (− 0.53 kg/m2, 95% CI − 0.72 to − 0.35) but failed to alter blood lipids. Conclusions Walking interventions improve many risk factors for cardiovascular disease. This underscores the central role of walking in physical activity for health promotion.
    • Effective compression therapy.

      Vowden, Kath; Vowden, Peter (2012)
    • Effective Dementia Education and Training for the Health and Social Care Workforce: A Systematic Review of the Literature

      Surr, Claire A.; Gates, C.; Irving, Donna; Oyebode, Jan R.; Smith, Sarah J.; Parveen, Sahdia; Drury, Michelle; Dennison, Alison (2017)
      Ensuring an informed and effective dementia workforce is of international concern; however, there remains limited understanding of how this can be achieved. This review aimed to identify features of effective dementia educational programs. Critical interpretive synthesis underpinned by Kirkpatrick’s return on investment model was applied. One hundred and fifty-two papers of variable quality were included. Common features of more efficacious educational programs included the need for educational programs to be relevant to participants’ role and experience, involve active face-to-face participation, underpin practice-based learning with theory, be delivered by an experienced facilitator, have a total duration of at least 8 hours with individual sessions of 90 minutes or more, support application of learning in practice, and provide a structured tool or guideline to guide care practice. Further robust research is required to develop the evidence base; however, the findings of this review have relevance for all working in workforce education.
    • Effective organizational change in healthcare: Exploring the contribution of empowered users and workers.

      Anders, C.; Cassidy, Andrea M. (2014-06)
      Worldwide healthcare systems are facing immense changes in the demand of care with vast cost explosions caused by aging populations and the increase in chronic and mental diseases. The move towards patient-centered healthcare seems to be an ideal approach to meet future challenges but still clashes with reality. Patient Advice and Liaison Service (PALS) in the UK is one of the unique examples of patient empowerment to influence changes in healthcare systems like the National Health Service (NHS). The purpose of this paper is to look at user-driven organizational change management in PALS in retrospect to learn from its ‘best’ and ‘worst’ practices. In conclusion, patient-centered healthcare becomes more realistic if healthcare users and workers are empowered at the same time. The vision of patient, public, and staff involvement in the move towards patient-centered health needs to be backed up by adequate and secure resources as well as consistent organizational leadership and change management. Organizational change processes in general should be seen as biological continuous cycles with unpredictable evolutionary turning points rather than linear progressions. This helps to stay optimistic and embrace change as challenging, exciting, and difficult all the way through the change process.
    • Effective utilization of oral hypoglycemic agents to achieve individualized HbA1c targets in patients with type 2 diabetes mellitus

      Bannister, Margaret; Berlanga, J. (2016-09)
      Type 2 diabetes is a progressive condition that may require the combination of three oral treatments to achieve optimal glycemic management to prevent microvascular and macrovascular complications whilst minimizing the risk of acute complications and side effects or adverse reactions to treatments. With the widening availability of treatment options and increasing importance of individualized treatment pathways, including personalized HbA1c targets, this article will explore the mode of action of currently available oral treatments, factors to consider when individualizing HbA1c targets, the relevance of estimated glomerular filtration rate assessment, and the importance of reviewing the clinical impact of all treatment decisions.
    • Effectiveness of educational interventions in improving detection and management of dementia in primary care: cluster randomised controlled study

      Downs, Murna G.; Bryans, M.; Turner, S.; Wilcock, J.; Keady, J.; Levin, E.; O'Carroll, R.; Howie, K.; Lliffe, S. (2006)
    • Effectiveness of fluoroscopy-guided intra-articular steroid injection for hip osteoarthritis

      Subedi, N.; Chew, N.S.; Chandramohan, M.; Scally, Andy J.; Groves, C. (2015-11-11)
      AIM: To demonstrate the benefits of fluoroscopy-guided intra-articular steroid injection in the hip with varying degrees of disease severity, and to investigate the financial aspects of the procedure and impact on waiting time. MATERIALS AND METHODS: A prospective study was undertaken of patients who underwent fluoroscopic intra-articular steroid injection over the 9-month study period. Comparative analysis of the Oxford hip pain score pre- and 6-8 weeks post-intra-articular injection was performed. Hip radiographs of all patients were categorised as normal, mild, moderate, or severe disease (four categories) based on the modified Kellgren-Lawrence severity scale, and improvement on the Oxford hip pain score on each of these four severity categories were assessed. RESULTS: Within the study cohort of 100 patients, the mean increase in post-procedure hip score of 7.32 points confirms statistically significant benefits of the therapy (p<0.001, 95% confidence interval: 5.55-9.09). There was no significant difference in pre-injection hip score or change in score between the four severity categories (p=0.51). Significant improvement in hip score (p<0.05) was demonstrated in each of the four severity categories 6-8 weeks post-injection. No associated complications were observed. CONCLUSION: The present study confirms that fluoroscopy-guided intra-articular steroid injection is a highly effective therapeutic measure for hip osteoarthritis across all grades of disease severity with significant cost savings and the potential to reduce waiting times.
    • The effectiveness of laser therapy on the management of chronic low back pain

      Carus, Catherine; Poon, Tsz Hin (2016)
      Background/Aim: Chronic low back pain (CLBP) is a global musculoskeletal challenge, resulting in pain and disability on individuals. Laser therapy can be used to treat CLBP. This review evaluates the effectiveness of laser therapy including high level laser therapy (HLLT) and low level laser therapy (LLLT) on CLBP in relation to pain or functional disability. Methods: The authors conducted a systematic review of randomised controlled trials (RCTs) and searched the Cochrane Library, MEDLINE, CINAHL, AMED and PEDro from their start to June 2015. All studies that met predetermined inclusion and exclusion criteria were appraised with The Cochrane Collaboration’s tool for assessing risk of bias and Critical Appraisal Skills Programme Tools in June, 2015. Findings: Six RCTs met the inclusion criteria: two RCTs reported significant improvement in pain and functional disability with the use of HLLT but with small sample size (n=103); one RCTs (n=61) reported significant improvement and three RCTs (n=215) reported insignificant improvement in pain and functional disability with the use of LLLT. Conclusion: On the strength of the evidence available HLLT and LLLT are not currently recommended to be replaced or be offered in addition to conventional treatment. Further rigorous research is required to confirm the potential use of laser therapy on individuals presenting with CLBP.
    • Effects of a psycho-educational intervention on direct care workers’ communicative behaviours with residents with dementia

      Barbosa, Ana; Marques, A.; Sousa, L.; Nolan, M.; Figueiredo, D. (2016)
      This study assessed the effects of a person-centred care based psycho-educational intervention on direct care workers’ communicative behaviours with people with dementia living in aged care facilities. An experimental study with a pre-posttest control group design was conducted in four aged care facilities. Two experimental facilities received an eight-weekly psycho-educational intervention aiming to develop workers’ knowledge about dementia, person-centred care competences and tools for stress management; control facilities received an education-only, with no support to deal with stress. A total of 332 morning care sessions, involving fifty-six direct care workers (female, mean age 44.72±9.02), were video-recorded before and two weeks after the intervention The frequency and duration of a list of verbal and non-verbal communicative behaviours were analysed. Within the experimental group there was a positive change from pre to post-test on the frequency of all workers’ communicative behaviours. Significant treatment effects in favour of the experimental group were obtained for the frequency of inform (p<0.01, ƞ2partial=0.09) and laugh (p<0.01, ƞ2 partial=0.18). Differences between groups emerged mainly in relation to non-verbal communicative behaviours. The findings suggest that a person-centred care based psycho-educational intervention can positively affect the direct care workers’ communicative behaviours with residents with dementia. Further research is required to determine the extent of the benefits of this approach.
    • Effects of a psychoeducational intervention for direct care workers caring for people with dementia: results from a 6-month follow-up study

      Barbosa, Ana; Nolan, M.; Sousa, L.; Marques, A.; Figueiredo, D. (2016-03)
      This study aimed to assess the effects of a psycho-educational intervention, designed to improve direct care workers’ stress, burnout and job satisfaction and person-centered communicative behavior with people with dementia. A pretest-posttest control group design was conducted in four aged-care facilities. Two experimental facilities received a psycho-educational intervention; two control facilities received an education-only. Data were gathered from fifty three care workers at baseline, immediately and six months after the intervention, through self-administrated instruments and video-recorded morning care sessions. The experimental group showed a significant decrease in care workers’ burnout and a significant improvement in several communicative behaviors (e.g., involvement). Stress levels deteriorated at six months and no intervention effects were found for job satisfaction. The findings highlight the importance of providing care workers with both technical competences and tools for stress management as this might be associated with a reduction of their levels of exhaustion and improved communicative behaviors.
    • The effects of blurring vision on medio-lateral balance during stepping up or down to a new level in the elderly

      Buckley, John G.; Elliott, David B.; Heasley, Karen; Scally, Andy J. (2005)
      Visual impairment is an important risk factor for falls, but relatively little is known about how it affects stair negotiation. The present study determined how medio-lateral (ML) dynamics of stepping and single limb support stability when stepping up or down to a new level were affected by blurring the vision of healthy elderly subjects. Twelve elderly subjects (72.3±4.2years) were analysed performing single steps up and single steps down to a new level (7.2, 14.4 and 21.6cm). Stepping dynamics were assessed by determining the ML ground reaction force (GRF) impulse, lateral position of the centre of mass (CM) relative to the supporting foot (average horizontal ML distance between CM and CP during single support) and movement time. Stability was determined as the rms fluctuation in ML position of the centre of pressure (CP) during single support. Differences between optimal and blurred visual conditions were analysed using a random effects model. Duration of double and single support, and the ML GRF impulse were significantly greater when vision was blurred, while the average CM¿CP ML distance and ML stability was reduced. ML stability decreased with increasing step height and was further decreased when stepping down than when stepping up. These findings indicate that ML balance during stepping up and down was significantly affected by blurring vision. In particular, single limb support stability was considerably reduced, especially so during stepping down. The findings highlight the importance of accurate visual feedback in the precise control of stepping dynamics when stepping up or down to a new level, and suggest that correcting common visual problems, such as uncorrected refractive errors and cataract may be an important intervention strategy in improving how the elderly negotiate stairs.
    • Effects of gaze strategy on standing postural stability in older multifocal wearers

      Johnson, Louise; Elliott, David B.; Buckley, John G. (2009)
      BACKGROUND: Postural instability in older people is associated with an increased risk of falling. This experiment investigated the effects of different gaze strategies on postural stability in older people, when using distance single-vision compared with multifocal (progressive addition lens and bifocal) spectacles. METHODS: Eighteen healthy older habitual multifocal spectacle-wearers (mean age 72.1 +/- 4.0 years) participated in a randomised, cross-over study. Postural stability during quiet standing was assessed as the root mean square excursion in the centre of pressure (RMS-COP) in the antero-posterior direction. Ground reaction force data were collected (for 30 seconds), while subjects viewed one of two visual targets (one square metre) of different spatial frequencies and contrasts, while wearing either distance single-vision or multifocal (progressive addition and bifocal) spectacles. The visual targets were positioned either ahead at eye-level or on the ground (viewing distance 2.06 metres) and viewed under the following head-gaze conditions; 'head neutral-gaze forward', 'head flexed-gaze down' and 'head neutral-gaze down'. RESULTS: The type of spectacles worn or the target viewed had no significant effect on postural stability but postural stability deteriorated (antero-posterior RMS-COP excursion increased) in the 'head neutral-gaze down' compared with the 'head flexed-gaze down' and 'head neutral-gaze forward' conditions (5.9, 5.5 and 5.0 mm respectively, p < 0.001). CONCLUSIONS: Multifocal use had no effect on standing postural stability. Irrespective of spectacles worn, when fixating a visual target positioned at ground level, postural stability was better in the 'head flexed-gaze down' condition compared with the 'head neutral-gaze down' condition. A useful strategy to reduce falling in the older person might be to advise multifocal and distance single-vision spectacle-wearers to flex their heads rather than just lower their eyes when looking downwards.
    • The effects of inter-organisational information technology networks on patient safety: a realist synthesis

      Keen, J.; Abdulwahid, M.; King, N.; Wright, J.; Randell, Rebecca; Gardner, Peter H.; Waring, J.; Longo, R.; Nikolova, S.; Sloan, C.; et al. (2020)
      Health services in many countries are investing in inter-organisational networks, linking patients’ records held in different organisations across a city or region. The aim of the systematic review was to establish how, why, and in what circumstances these networks improve patient safety, fail to do so, or increase safety risks, for people living at home. Design Realist synthesis, drawing on both quantitative and qualitative evidence, and including consultation with stakeholders in nominal groups and semi-structured interviews. Eligibility criteria The co-ordination of services for older people living at home, and medicine reconciliation for older patients returning home from hospital. Information sources 17 sources including Medline, Embase, CINAHL, Cochrane Library, Web of Science, ACM Digital Library and Applied Social Sciences Index and Abstracts (ASSIA). Outcomes Changes in patients’ clinical risks. Results We did not find any detailed accounts of the sequences of events that policy makers and others believe will lead from the deployment of interoperable networks to improved patient safety. We were, though, able to identify a substantial number of theory fragments, and these were used to develop programme theories. There is good evidence that there are problems with the co-ordination of services in general, and the reconciliation of medication lists in particular, and it indicates that most problems are social and organisational in nature. There is also good evidence that doctors and other professionals find interoperable networks difficult to use. There was limited high quality evidence about safety-related outcomes associated with the deployment of interoperable networks. Conclusions Empirical evidence does not currently justify claims about the beneficial effects of interoperable networks on patient safety. There appears to be a mismatch between technology-driven assumptions about the effects of networks and the socio-technical nature of co-ordination problems. Review registration: PROSPERO CRD42017073004
    • Effects of Maths on the Move on Children’s Perspectives, Physical Activity, and Maths Performance

      Morris, J.L.; Archbold, V.S.J.; Bond, S.J.; Daly-Smith, Andrew (2022-01)
      Purpose To assess the impact of a six-week ‘Maths on the Move’ (MOTM) physically active learning programme on primary school children’s physical activity (PA) levels and maths performance. Method Randomised control trial. Year 5 children’s PA was assessed using accelerometry for five consecutive school days at baseline and during the final intervention week (final sample: n=97, age M=9.61±0.29, 52.6% female). Two maths performance tests were used; one assessing mathematical content taught during MOTM and one assessing math’s fluency (MASSAT). Both tests were conducted at baseline and following the intervention (week seven). Focus groups were conducted in week seven with intervention children (n=12), randomly choosing an even split of children classified with pre-intervention low or high PA levels. Results On average, during a typical 45-49 minutes MOTM lesson, children obtained an additional five minutes of moderate-to-vigorous PA and 5.7 minutes of light PA counteracted by a reduction of 9.5 minutes of time spent sedentary compared to children that remained in the classroom (control condition). The maths attainment test performance significantly improved over time for children in the MOTM compared to the control (+6.1 versus +0.9, p≤0.0001, d=1.507). No significant improvements were found in the MASSAT total score. Seven emerging themes were derived from the child focus groups. Children felt the MOTM sessions resulted in social and environmental improvements, which improved learning during the sessions. Children described the MOTM sessions as enjoyable, fun, engaging and invigorating – resulting in positive associations to learning and activity. Conclusion Collectively, the findings identify the MOTM programme improves pupil’s PA levels, academic outcomes and identifies pupil’s willingness, enjoyment, and engagement.
    • Effects of person-centered care approaches to dementia care on staff: a systematic review

      Barbosa, Ana; Sousa, L.; Nolan, M.; Figueiredo, D. (2015-12-01)
      Person-centered care (PCC) has been the subject of several intervention studies, reporting positive effects on people with dementia. However, its impact on staff’s outcomes remains unclear. The purpose of this systematic review was to assess the impact of PCC approaches on stress, burnout and job satisfaction of staff caring for people with dementia in care homes. The databases PubMed, Web of Knowledge, Scopus and EBSCO and reference lists from relevant publications, were searched between December 2012 and March 2013. The review was limited to experimental and quasi-experimental studies, published in English and involving direct care workers (DCWs). Seven studies were included, addressing different PCC approaches: dementia care mapping (n=1); stimulation-oriented approaches (n=2); emotion-oriented approaches (n=2) and behavioral-oriented approaches (n=2). Five studies reported benefits on DCWs, suggesting a tendency towards the effectiveness of PCC on staff. However, methodological weaknesses and heterogeneity among studies make it difficult to draw firm conclusions.
    • Effects of social restrictions on people with dementia and carers during the pre-vaccine phase of the COVID-19 pandemic: Experiences of IDEAL cohort participants

      Pentecost, C.; Collins, R.; Stapley, S.; Victor, C.; Quinn, Catherine; Hillman, A.; Litherland, R.; Allan, L.; Clare, L. (2022)
      This qualitative study was designed to understand the impact of social distancing measures on people with dementia and carers living in the community in England and Wales during a period of social restrictions before the COVID-19 vaccination roll-out. We conducted 12 semi-structured interviews with people with dementia aged 50-88 years, living alone or with a partner, and 10 carers aged 61-78 years, all living with the person with dementia. Three of the interviews were with dyads. Participants were recruited during November and December 2020. We used framework analysis to identify themes and elicit suggestions for potential solutions. We identified three interrelated themes. People with dementia experienced a fear of decline in capabilities or mood and attempted to mitigate this. Carers noticed changes in the person with dementia and increased caring responsibilities, and for some, a change in the relationship. Subsequently, reduced confidence in capabilities to navigate a new and hostile environment created a cyclical dilemma of re-engaging where an inability to access usual activities made things worse. People with dementia and carers experienced neglect and being alone in their struggle, alongside feeling socially excluded during the pandemic, and there was little optimism associated with the upcoming vaccine programme. People found their own solutions to reduce the effects of isolation by keeping busy and being socially active, and practising skills deemed to help reduce the progression of dementia. This and some limited local public initiatives for the general public facilitated feelings of social inclusion. This study adds understanding to existing evidence about the longer-term experience of social isolation several months into the pandemic. It highlights the importance of health and community groups and suggests how services can find ways to support, include, and interact with people with dementia and carers during and after social restrictions.
    • Effects of stress on nursing integrity

      McIntosh, Bryan; Sheppy, B. (2013)
      This article looks at the relationship between stress, nursing integrity and patient care. It has been argued that the professional integrity of nurses has been eroded and consequently they have become more susceptible to anxiety, stress and exhaustion, potentially affecting care delivery. The authors suggest that the goal of providing high professional standards is threatened by increased service demands, and there is therefore a need for nurses to develop effective coping strategies to manage stress resulting from competing tensions in the workplace.; � This article looks at the relationship between stress, nursing integrity and patient care. It has been argued that the professional integrity of nurses has been eroded and consequently they have become more susceptible to anxiety, stress and exhaustion, potentially affecting care delivery. The authors suggest that the goal of providing high professional standards is threatened by increased service demands, and there is therefore a need for nurses to develop effective coping strategies to manage stress resulting from competing tensions in the workplace.
    • Effects of water and land based exercise programmes on women experiencing pregnancy-related pelvic girdle pain: a randomized controlled feasibility study

      Scott, K.L.; Hellawell, Michael (2018-06)
      This study aimed to address whether a water exercise programme improves pain and quality of life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise programme and the feasibility of undertaking a large-scale research programme. Twenty-three participants with diagnosed PGP, recruited at St George’s Hospital London, were randomised into two groups (water or land exercise). Each group received, four, once-weekly exercise sessions on land or water. Exercise effects on PGP were measured using the Pelvic Girdle Pain Questionnaire (PGPQ) (primary outcome), Visual Analogue Scale (VAS), Patient Specific Functional Score (PSFS) and Active Straight Leg Raise (ASLR). Quality of life was measured using the Subjective Exercise Experience Scale (SEES). Outcomes were assessed at baseline and post four weeks exercise. Results showed there was a clinically significant improvement shown in all outcome measures in the water group, compared to the land group. A statistical difference between groups was shown for ASLR (p=0.036), Positive Well-Being (p=0.000) and Fatigue levels (p=0.011). No statistical difference was shown for PGPQ (p=0.056), PSFS (p=0.530) and Psychological Distress (p=0.712) scores. Exercise in water appears to offer a clinical benefit for patients experiencing PGP compared to a land exercise, particularly with Fatigue, Positive Well-Being and ASLR scores. Statistical differences between groups are limited by small sample size and that no power calculation was used in this study. Methodology and results provide support for a larger study on this topic to provide more definitive conclusions to support the use of water-based therapy for PGP.
    • Efficacy and safety of different techniques of paravertebral block for analgesia after thoracotomy: a systematic review and metaregression.

      Kotze, A.; Scally, Andy J.; Howell, S. (2009)
      Various techniques and drug regimes for thoracic paravertebral block (PVB) have been evaluated for post-thoracotomy analgesia, but there is no consensus on which technique or drug regime is best. We have systematically reviewed the efficacy and safety of different techniques for PVB. Our primary aim was to determine whether local anaesthetic (LA) dose influences the quality of analgesia from PVB. Secondary aims were to determine whether choice of LA agent, continuous infusion, adjuvants, pre-emptive PVB, or addition of patient-controlled opioids improve analgesia. Indirect comparisons between treatment arms of different trials were made using metaregression. Twenty-five trials suitable for metaregression were identified, with a total of 763 patients. The use of higher doses of bupivacaine (890¿990 mg per 24 h compared with 325¿472.5 mg per 24 h) was found to predict lower pain scores at all time points up to 48 h after operation (P=0.006 at 8 h, P=0.001 at 24 h, and P<0.001 at 48 h). The effect-size estimates amount to around a 50% decrease in postoperative pain scores. Higher dose bupivacaine PVB was also predictive of faster recovery of pulmonary function by 72 h (effect-size estimate 20.1% more improvement in FEV1, 95% CI 2.08%¿38.07%, P=0.029). Continuous infusions of LA predicted lower pain scores compared with intermittent boluses (P=0.04 at 8 h, P=0.003 at 24 h, and P<0.001 at 48 h). The use of adjuvant clonidine or fentanyl, pre-emptive PVB, and the addition of patient-controlled opioids to PVB did not improve analgesia. Further well-designed trials of different PVB dosage and drug regimes are needed.
    • Efficacy of a therapeutic wand in addition to physiotherapy for treating bladder pain syndrome in women: a pilot randomized controlled trial

      Bond, J.; Pape, Hilary; Ayre, Colin A. (2017)
      The aim of this study was to assess the feasibility of a randomized controlled trial (PFM) treatment in women with bladder pain syndrome (BPS). Prolonged PFM tension contributes to the bladder pain, urinary frequency and urgency associated with BPS. Pelvic health physiotherapists routinely provide intravaginal myofascial release (MFR) to the PFMs in order to effectively reduce symptoms. Rapid access A TW was designed so as to allow men with chronic pelvic pain to self- treat, and this may be effective in women with BPS. For 6 weeks, two groups received weekly physiotherapist- provided MFR, and were monitored for a further 6- week follow- up period. One group also used a TW at home three times a week throughout the pilot. Weekly outcome measures of BPS symptoms and quality of life were recorded. A clinically meaningful difference in Interstitial Cystitis Symptoms Index and Interstitial Cystitis Problem Index score changes between groups was group = 6.20 ± 0.83 and 5.00 ± 1.41, respectively), and a difference was observed during the follow- up period (control group = 4.50 ± 1.73 and 4.00 ± 2.44, respecevents. Using the TW appears to have enhanced physiotherapy treatment during the initial 6 weeks, and improved symptoms during the 6- week follow- up period. The TW may be a clinically useful tool for long- term management of BPS. The feasibility of the study method was proven, some alterations were recommended and an RCT is now warranted.