scholarly journals The use of cardiac rehabilitation services to aid the recovery of patients with bowel cancer: a pilot randomised controlled trial with embedded feasibility study

2016 ◽  
Vol 4 (24) ◽  
pp. 1-232 ◽  
Author(s):  
Gill Hubbard ◽  
Julie Munro ◽  
Ronan O’Carroll ◽  
Nanette Mutrie ◽  
Lisa Kidd ◽  
...  
Keyword(s):  
Cardiac Rehabilitation ◽  
Controlled Trial ◽  
Phase 1 ◽  
Bowel Cancer ◽  
Phase 2 ◽  
Future Trial ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

BackgroundColorectal cancer (CRC) survivors are not meeting the recommended physical activity levels associated with improving their chances of survival and quality of life. Rehabilitation could address this problem.ObjectivesThe aims of the Cardiac Rehabilitation In Bowel cancer study were to assess whether or not cardiac rehabilitation is a feasible and acceptable model to aid the recovery of people with CRC and to test the feasibility and acceptability of the protocol design.DesignIntervention testing and feasibility work (phase 1) and a pilot randomised controlled trial with embedded qualitative study (phase 2), supplemented with an economic evaluation. Randomisation was to cardiac rehabilitation or usual care. Outcomes were differences in objective measures of physical activity and sedentary behaviour, self-reported measures of quality of life, anxiety, depression and fatigue. Qualitative work involved patients and clinicians from both cancer and cardiac specialties.SettingThree colorectal cancer wards and three cardiac rehabilitation facilities.ParticipantsInclusion criteria were those who were aged > 18 years, had primary CRC and were post surgery.ResultsPhase 1 (single site) – of 34 patient admissions, 24 (70%) were eligible and 4 (17%) participated in cardiac rehabilitation. Sixteen clinicians participated in an interview/focus group. Modifications to trial procedures were made for further testing in phase 2. Additionally, 20 clinicians in all three sites were trained in cancer and exercise, rating it as excellent. Phase 2 (three sites) – screening, eligibility, consent and retention rates were 156 (79%), 133 (67%), 41 (31%) and 38 (93%), respectively. Questionnaire completion rates were 40 (97.5%), 31 (75%) and 25 (61%) at baseline, follow-up 1 and follow-up 2, respectively. Forty (69%) accelerometer data sets were analysed; 20 (31%) were removed owing to invalid data.Qualitative studyCRC and cardiac patients and clinicians were interviewed. Key themes were benefits and barriers for people with CRC attending cardiac rehabilitation; generic versus disease-specific rehabilitation; key concerns of the intervention; and barriers to participation (CRC participants only).Economic evaluationThe average out-of-pocket expenses of attending cardiac rehabilitation were £50. The costs of cardiac rehabilitation for people with cancer are highly dependent on whether it involves accommodating additional patients in an already existing service or setting up a completely new service.Limitations and conclusionsThe main limitation is that this is a small feasibility and pilot study. The main novel finding is that cardiac rehabilitation for cancer and cardiac patients together is feasible and acceptable, thereby challenging disease-specific rehabilitation models.Future workThis study highlighted important challenges to doing a full-scale trial of cardiac rehabilitation but does not, we believe, provide sufficient evidence to reject the possibility of such a future trial. We recommend that any future trial must specifically address the challenges identified in this study, such as suboptimal consent, completion, missing data and intervention adherence rates and recruitment bias, and that an internal pilot trial be conducted. This should have clear ‘stop–proceed’ rules that are formally reviewed before proceeding to the full-scale trial.Trial registrationCurrent Controlled Trials ISRCTN63510637.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full inHealth Services and Delivery Research; Vol. 4, No. 24. See the NIHR Journals Library website for further project information.

scholarly journals Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): study protocol for a pilot randomised controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
M. Rohr ◽  
S. Brandstetter ◽  
C. Bernardi ◽  
C. Fisser ◽  
K. P. Drewitz ◽  
...  
Keyword(s):  
Intensive Care ◽  
Controlled Trial ◽  
Pilot Randomised Controlled Trial ◽  
Potential Efficacy ◽  
Related Quality ◽  
Pilot Rct ◽  
Health Related ◽  
Randomised Controlled

Abstract Background Intensive care unit (ICU) survivors often suffer from cognitive, physical and mental impairments, known as post-intensive care syndrome (PICS). ICU follow-up clinics may improve aftercare of these patients. There is a lack of evidence whether or which concept of an ICU follow-up clinic is effective. Within the PINA study, a concept for an ICU follow-up clinic was developed and will be tested in a pilot randomised controlled trial (RCT), primarily to evaluate the feasibility and additionally the potential efficacy. Methods/design Design: Pilot RCT with intervention and control (usual care) arms plus mixed-methods process evaluation. Participants: 100 ICU patients (50 per arm) of three ICUs in a university hospital (Regensburg, Germany), ≥ 18 years with an ICU stay of > 5 days, a sequential organ failure assessment (SOFA) score > 5 during the ICU stay and a life expectancy of more than 6 months. Intervention: The intervention will contain three components: information, consultation and networking. Information will be available in form of an intensive care guide for patients and next of kin at the ICU and phone support during follow-up. For consultation, patients will visit the ICU follow-up clinic at least once during the first 6 months after discharge from ICU. During these visits, patients will be screened for symptoms of PICS and, if required, referred to specialists for further treatment. The networking part (e.g. special referral letter from the ICU follow-up clinic) aims to provide a network of outpatient care providers for former ICU patients. Feasibility Outcomes: Qualitative and quantitative evaluation will be used to explore reasons for non-participation and the intervention´s acceptability to patients and caregivers. Efficacy Outcomes: Health-related quality of life (HRQOL) will be assessed as primary outcome by the physical component score (PCS) of the Short-Form 12 Questionnaire (SF-12). Secondary outcomes encompass further patient-reported outcomes. All outcomes are assessed at 6 months after discharge from ICU. Discussion The PINA study will determine feasibility and potential efficacy of a complex intervention in a pilot RCT to enhance follow-up care of ICU survivors. The pilot study is an important step for further studies in the field of ICU aftercare and especially for the implementation of a pragmatic multi-centre RCT. Trial registration ClinicalTrials.gov, NCT04186468. Submitted 2 December 2019

scholarly journals A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 910
Author(s):  
Dorthe Djernis ◽  
Mia S. O’Toole ◽  
Lone O. Fjorback ◽  
Helle Svenningsen ◽  
Mimi Y. Mehlsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Self Compassion ◽  
Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

scholarly journals P001 IS PROPHYLACTIC MESH IS ROUTINELY REQUIRED FOR STOMA CONSTRUCTION? IDENTIFICATION OF THE ‘TARGET GROUP’

2021 ◽  
Vol 108 (Supplement_8) ◽  
Author(s):  
Ahmed Hassan ◽  
Wei Toh ◽  
James Ayathamattam ◽  
Zachary Thomas ◽  
Ondrej Ryska
Keyword(s):  
Controlled Trial ◽  
Cost Benefit ◽  
Prophylactic Mesh ◽  
Nice Guidelines ◽  
Prophylactic Measures ◽  
Increased Risk ◽  
End Colostomy ◽  
Randomised Controlled

Abstract Background Evidence to support routine prophylactic mesh insertion during stoma construction is conflicting. The PREVENT randomised controlled trial (RCT) suggested lower incidence of parastomal hernia (PSH) with prophylactic mesh but with no quality of life or cost benefit. Another two RCTs has shown no prophylactic benefit (STOMAMESH & STOMA-const). Although European Hernia guidelines recommends routine prophylactic mesh in end-colostomy, NICE guidelines suggest mesh on individual basis not routinely. Aim To identify the group with higher risk to develop a symptomatic PSH when prophylactic mesh should be considered Material and Methods A single center retrospective review of all stoma formed. Younger patient than 18 years and patients who had less than 6 months’ follow-up were excluded. Development of PSH was confirmed by radiological evidence or direct intra-operative visualization Results 194 patients between January 2015 till December 2019 were included with mean follow-up of 15.7±13.5 months where 91 patients developed PSH. On multivariate analysis, older age (>65) (OR 2.3, 95% CI 1.08 – 4.99, p 0.03) and Obesity (OR 5.8, 95% CI 2.53 – 13.57, p 0.00) were risk factors of developing PSH. Among the PSH group, 28 were symptomatic (31%). Symptomatic subgroup had higher ASA (ASA >2) than asymptomatic subgroup (50% Vs 27%, p 0.05) Conclusions Obese patients older than 65 years are at increased risk of PSH. IF their ASA >2 this PSH is likely to become symptomatic. This is the group who should benefit the most from prophylactic measures including mesh insertion and should be targeted for future trials

scholarly journals Stress Management in Elementary School Students: a Pilot Randomised Controlled Trial

2021 ◽  
Vol 26 (1) ◽  
pp. e976
Author(s):  
Katerina Sofianopoulou ◽  
Flora Bacopoulou ◽  
Dimitrios Vlachakis ◽  
Ioulia Kokka ◽  
Evaggelos Alexopoulos ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Elementary School ◽  
Randomised Controlled Trial ◽  
Elementary School Students ◽  
Controlled Trial ◽  
Intervention Group ◽  
School Students ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Research has shown that stress experiences begin in early stages of life. Stress management techniques have appeared to be beneficial for the development or enhancement of stress coping skills. The aim of this pilot randomised controlled trial was to assess the effect of a 12-week intervention, comprising training in diaphragmatic breathing and progressive muscular relaxation, on elementary school students’ stress levels. Outcomes on the quality of life and behavioural aspects of the students were also assessed. Standardised questionnaires were administered at baseline and after the 12-week intervention program. Fifty-two children aged 10 to 11 years were randomly assigned to intervention (n=24) and control groups (n=28). Children of the intervention group demonstrated lower levels of stress (in all three subscales of lack of well-being, distress, and lack of social support) and improved aspects of quality of life (physical, emotional, and school functioning). No significant differences were observed regarding the examined behavioural dimensions, in the intervention group. Larger randomised controlled trials with follow-up evaluations are needed to ascertain the positive outcomes of such programs on elementary school children.

The Nature stroke study; NASTRU - A randomised controlled trial of nature-based post-stroke fatigue rehabilitation

2019 ◽  
Author(s):  
Anna María Pálsdóttir ◽  
Kjerstin Stigmar ◽  
Bo Norrving ◽  
Patrik Grahn ◽  
Ingemar F Petersson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Perceived Value ◽  
Control Group ◽  
Post Stroke ◽  
Randomised Controlled

Abstract Fatigue is common after stroke and contributes to disability and impaired quality of life. Currently, there is insufficient evidence on the efficacy of any intervention for post-stroke fatigue. The aim of the study was to examine whether 10 weeks Nature-based rehabilitation (NRB) as add-on to standard care may improve post-stroke fatigue, perceived value of everyday occupations, function, activity and participation compared to standard care only (Clinical Trial.gov Identifier: NCT02435043, 2012/352, 05-06-2015). The study was carried out as a single blinded two-armed randomised controlled trial. Stroke survivors identified through routine 3-month follow-up visit (sub-acute) or medical records (chronic stroke > 1 year earlier) were randomised to Standard care + NBR or Standard care only. Blinded evaluations were conducted at follow-up 8 and 14 months after randomisation. The primary outcomes were post-stroke fatigue (Mental Fatigue Scale, total score) and perceived value of everyday occupations (Oval-pd) 8 months after randomisation. About a quarter of the screened patients were eligible; half accepted to participate and 101 were randomised, mean age 67 years, 60% female. The patients with sub-acute stroke were highly compliant with the intervention. Fatigue decreased to a value below the suggested cut-off for mental fatigue (<10.5) in the intervention group but not in the control group; no statistically significant differences were found though between the groups. Conclusion: NASTRU is the first randomised study on NBR for patients with post stroke fatigue. NBR was feasible and well tolerated. The study was underpowered due to difficulties in recruiting participants. No significant differences were detected between intervention and control group. A larger RCT is warranted. Keywords: clinical trial, enriched environment, everyday occupations, horticulture therapy, quality of life.

scholarly journals Evaluation of a positive psychotherapy group intervention for people with psychosis: pilot randomised controlled trial

2015 ◽  
Vol 25 (3) ◽  
pp. 235-246 ◽  
Author(s):  
Beate Schrank ◽  
Tamsin Brownell ◽  
Zivile Jakaite ◽  
Charley Larkin ◽  
Francesca Pesola ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Group Intervention ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Self Esteem ◽  
Positive Psychotherapy ◽  
Main Effect ◽  
Randomised Controlled

Aims.Third-wave psychological interventions have gained relevance in mental health service provision but their application to people with psychosis is in its infancy and interventions targeting wellbeing in psychosis are scarce. This study tested the feasibility and preliminary effectiveness of positive psychotherapy adapted for people with psychosis (WELLFOCUS PPT) to improve wellbeing.Methods.WELLFOCUS PPT was tested as an 11-week group intervention in a convenience sample of people with psychosis in a single centre randomised controlled trial (ISRCTN04199273) involving 94 people with psychosis. Patients were individually randomised in blocks to receive either WELLFOCUS PPT in addition to treatment as usual (TAU), or TAU only. Assessments took place before randomisation and after the therapy. The primary outcome was wellbeing (Warwick-Edinburgh Mental Well-Being Scale, WEMWBS). Secondary outcomes included symptoms (Brief Psychiatric Rating Scale), depression (Short Depression-Happiness Scale), self-esteem, empowerment, hope, sense of coherence, savouring beliefs and functioning, as well as two alternative measures of wellbeing (the Positive Psychotherapy Inventory and Quality of Life). Intention-to-treat analysis was performed. This involved calculating crude changes and paired-sample t-tests for all variables, as well as ANCOVA and Complier Average Causal Effect (CACE) Analysis to estimate the main effect of group on all outcomes.Results.The intervention and trial procedures proved feasible and well accepted. Crude changes between baseline and follow-up showed a significant improvement in the intervention group for wellbeing according to all three concepts assessed (i.e., WEMWBS, Positive Psychotherapy Inventory and Quality of Life), as well as for symptoms, depression, hope, self-esteem and sense of coherence. No significant changes were observed in the control group. ANCOVA showed no main effect on wellbeing according to the primary outcome scale (WEMWBS) but significant effects on symptoms (p = 0.006, ES = 0.42), depression (p = 0.03, ES = 0.38) and wellbeing according to the Positive Psychotherapy Inventory (p = 0.02, ES = 0.30). Secondary analysis adapting for therapy group further improved the results for symptom reduction (p = 0.004, ES = 0.43) and depression (p = 0.03, ES = 0.41) but did not lead to any more outcomes falling below the p = 0.05 significance level. CACE analysis showed a non-significant positive association between the intervention and WEMWBS scores at follow-up (b = 0.21, z = 0.9, p = 0.4).Conclusions.This study provides initial evidence on the feasibility of WELLFOCUS PPT in people with psychosis, positively affecting symptoms and depression. However, more work is needed to optimise its effectiveness. Future research might evaluate positive psychotherapy as a treatment for comorbid depression in psychosis, and consider alternative measurements of wellbeing.

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