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An intervention for pulmonary rehabilitators to develop a social identity for patients attending exercise rehabilitation: a feasibility and pilot randomised control trial protocol.

ABSTRACT: Background:Chronic obstructive pulmonary disease (COPD) is a degenerative condition that can impair health-related quality of life (HRQoL). A number of self-management interventions, employing a variety of behavioural change techniques (BCTs), have been adopted to improve HRQoL for COPD patients. However, a lack of attention has been given to group management interventions with an emphasis on incorporating BCTs into rehabilitators' practice. This study aims to pilot and feasibly explore a social identity group management intervention, delivered by COPD rehabilitation staff to patients attending exercise pulmonary rehabilitation. Doing so will help inform the plausibility of the intervention before conducting a full trial to evaluate its effectiveness to improve HRQoL. Methods:This is a two-centre, randomised cross-over controlled trial. Two pulmonary rehabilitation centres based in the UK will be randomly allocated to two treatment arms (standard care and intervention). Outcome measurements relating to HRQoL and social identity will be completed pre- and post-exercise rehabilitation. Focus group interviews will be conducted at the end of exercise rehabilitation to capture participants' contextualised experiences of the intervention. COPD rehabilitators will undertake semi-structured interviews at the end of the trial to garner their holistic perspectives of intervention fidelity and implementation. Discussion:This is the first study to adopt a social identity approach to develop a rehabilitator-led, group management intervention for COPD patients attending exercise pulmonary rehabilitation. The results of this study will provide evidence for the feasibility and sample size requirements to inform a larger study, which can ascertain the intervention's effectiveness for improving HRQoL for COPD patients. Trial registration:ClinicalTrials.gov NCT02288039. Date 31 October 2014.

SUBMITTER: Levy AR

PROVIDER: S-EPMC5787301 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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An intervention for pulmonary rehabilitators to develop a social identity for patients attending exercise rehabilitation: a feasibility and pilot randomised control trial protocol.

Levy Andrew R AR Matata Bashir B Pilsworth Sam S Mcgonigle Adrian A Wigelsworth Lyndsey L Jones Linda L Pott Nicola N Bettany Max M Midgley Adrian W AW

Pilot and feasibility studies 20180127

<h4>Background</h4>Chronic obstructive pulmonary disease (COPD) is a degenerative condition that can impair health-related quality of life (HRQoL). A number of self-management interventions, employing a variety of behavioural change techniques (BCTs), have been adopted to improve HRQoL for COPD patients. However, a lack of attention has been given to group management interventions with an emphasis on incorporating BCTs into rehabilitators' practice. This study aims to pilot and feasibly explore ...[more]

PMID: 29423258

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Project description:BackgroundThe value of cardiac rehabilitation (CR) after a transient ischaemic attack (TIA) or minor stroke is untested despite these conditions sharing similar pathology and risk factors to coronary heart disease. We aimed to evaluate the feasibility of conducting a trial of an adapted home-based CR programme, 'The Healthy Brain Rehabilitation Manual', for patients following a TIA/minor stroke, participants' views on the intervention and, to identify the behaviour change techniques (BCTs) used.MethodsClinicians were asked to identify patients attending the Ulster Hospital, Belfast within 4 weeks of a first TIA or minor stroke. Those who agreed to participate underwent assessments of physical fitness, cardiovascular risk, quality of life and mental health, before random allocation to: Group (1) standard/usual care; (2) rehabilitation manual or (3) manual plus pedometer. All participants received telephone support at 1 and 4 weeks, reassessment at 6 weeks and an invitation to a focus group exploring views regarding the study. Two trained review authors independently assessed the manual to identify the BCTs used.ResultsTwenty-eight patients were invited to participate, with 15 (10 men, 5 women; 9 TIA, 6 minor stroke; mean age 69 years) consenting and completing the study. Mean time to enrolment from the TIA/stroke was 20.5 days. Participants completed all assessment measures except VO2max testing, which all declined. The manual and telephone contact were viewed positively, as credible sources of advice. Pedometers were valued highly, particularly for goal-setting. Overall, 36 individual BCTs were used, the commonest being centred around setting goals and planning as well as social support.ConclusionRecruitment and retention rates suggest that a trial to evaluate the effectiveness of a novel home-based CR programme, implemented within 4 weeks of a first TIA/minor stroke is feasible. The commonest BCTs used within the manual revolve around goals, planning and social support, in keeping with UK national guidelines. The findings from this feasibility work have been used to further refine the next stage of the intervention's development, a pilot study.Trial registrationClinicalTrials.gov Identifier: NCT02712385 . This study was registered prospectively on 18/03/2016.

Project description:BackgroundPulmonary rehabilitation is a cost-effective management strategy in chronic obstructive pulmonary disease (COPD) which improves exercise performance and health-related quality of life. Nutritional supplementation may counter malnutrition and enhance pulmonary rehabilitation outcomes but rigorous evidence is absent. We aimed to investigate the effect of high-protein supplementation (Fortisip Compact Protein (FCP)) during pulmonary rehabilitation on exercise capacity.MethodsThis was a double-blind randomised controlled trial comparing FCP (intervention) with PreOp (a carbohydrate control supplement) in COPD patients participating in a pulmonary rehabilitation programme. Participants consumed the supplement twice a day during pulmonary rehabilitation and attended twice-weekly pulmonary rehabilitation sessions, with pre- and post-pulmonary rehabilitation measurements, including the incremental shuttle walk test (ISWT) distance at 6 weeks as the primary outcome. Participants' experience using supplements was assessed.Results68 patients were recruited (intervention n=36 and control n=32). The trial was stopped early due to the COVID-19 pandemic. Although statistical significance was not reached, there was the suggestion of a clinically meaningful difference in the ISWT distance at 6 weeks favouring the intervention group (intervention 342±149 m (n=22) versus control 305±148 m (n=22); p=0.1). Individuals who achieved an improvement in the ISWT had a larger mid-thigh circumference at baseline (responders 62±4 cm versus nonresponders 55±6 cm; p=0.006). 79% of the patients were satisfied with the taste and 43% would continue taking the FCP.ConclusionsAlthough the data did not demonstrate a statistically significant difference in the ISWT, high-protein supplementation in COPD during pulmonary rehabilitation may result in a clinically meaningful improvement in exercise capacity and was acceptable to patients. Large, adequately powered studies are justified.

Project description:BackgroundSugammadex reduces residual neuromuscular blockade after anaesthesia, potentially preventing postoperative pulmonary complications. However, definitive evidence is lacking. We therefore conducted a feasibility and pilot trial for a large randomised controlled trial of sugammadex, neostigmine, and postoperative pulmonary complications.MethodsPatients aged ≥40 years having elective or expedited abdominal or intrathoracic surgery were recruited in Australia and Hong Kong. Perioperative care was at the discretion of clinicians, except for the use of rocuronium and/or vecuronium for neuromuscular blockade and the randomised intervention (sugammadex or neostigmine) for reversal. Feasibility measurements included recruitment, crossover, acceptability, completeness, and workload. Trial coordinator feedback was systematically sought. Patient-reported quality of life was measured using the EQ-5D-5L score. The primary pilot outcome was the incidence of new pulmonary complications up to hospital discharge (or postoperative day 7 if still in hospital).ResultsAmong 150 eligible patients, 120 consented to participate (recruitment rate 80%, 95% confidence interval [CI] 73 to 86%). The randomised intervention was administered without crossover to 115 of 117 patients who received reversal (98%, 95% CI 94 to 100%). The protocol was acceptable or highly acceptable to the anaesthetist in 108 of 116 cases (93%, 95% CI 87 to 97%; missing = 4). Four patients of the 120 patients were lost to follow-up at 3 months (3.3%, 95% CI 0.9 to 8.3%). Case report forms were complete at 3 months for all remaining patients. The median time to complete trial processes was 3.5 h (range 2.5-4.5 h). Trial coordinators reported no barriers to trial processes. Patients were aged 64 (standard deviation 11) years, 70 (58%) were male and 50 (42%) were female, and planned surgeries were thoracic (23 [19%]), upper abdominal (41 [34%]), and lower abdominal (56 [47%]). The primary outcome was observed in 5 (8.5%) of the 59 sugammadex patients and 5 (8.2%) of the 61 neostigmine patients (odds ratio 1.02, 95% CI 0.28 to 3.67).ConclusionsA large international randomised controlled trial of sugammadex, neostigmine and postoperative pulmonary complications in adult patients having abdominal and intrathoracic surgery, including collection of cost-effectiveness evidence for Health Technology Appraisal, is feasible.Trial registrationProspectively registered at the Australian and New Zealand Clinical Trials Registry ( ACTRN12620001313921 ) on December 7, 2020. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380645&isReview=true .

Project description:BackgroundSupervised cardio-pulmonary rehabilitation may be safe and beneficial for people with pulmonary hypertension (PH) in groups 1 (pulmonary arterial hypertension) and 4 (chronic thromboembolic disease), particularly as a hospital in-patient. It has not been tested in the most common PH groups; 2 (left heart disease), 3 (lung disease), or 5 (other disorders). Further it has not been evaluated in the UK National Health Service (NHS) out-patient setting, or with long-term follow-up. The aim of this randomised controlled trial (RCT) is to test the clinical and cost-effectiveness of a supervised exercise rehabilitation intervention with psychosocial support compared to best practice usual care for people with PH in the community/outpatient setting.MethodsThis multi-centre, pragmatic, two-arm RCT with embedded process evaluation aims to recruit 352 clinically stable adults with PH (groups 1-5) and WHO functional class II-IV. Participants will be randomised to either the Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention or control. The SPHERe intervention consists of 1) individual assessment and familiarisation sessions; 2) 8-week, twice-weekly, supervised out-patient exercise training; 3) psychosocial/motivational support and education; 4) guided home exercise plan. The control intervention consists of best practice usual care with a single one-to-one practitioner appointment, and general advice on physical activity. Outcomes will be measured at baseline, 4 months (post-intervention) and 12 months by researchers blinded to treatment allocation. The primary outcome is the incremental shuttle walk test at 4 months. Secondary outcomes include health-related quality of life (HRQoL), time to clinical worsening and health and social care use. A purposive sample of participants (n = 20 intervention and n = 20 control) and practitioners (n = 20) will be interviewed to explore experiences of the trial, outcomes and interventions.DiscussionThe SPHERe study is the first multi-centre clinical RCT to assess the clinical and cost effectiveness of a supervised exercise rehabilitation intervention compared to usual care, delivered in the UK NHS, for people in all PH groups. Results will inform clinicians and commissioners as to whether or not supervised exercise rehabilitation is effective and should be routinely provided for people with PH.Trial registrationISRCTN no. 10608766, prospectively registered on 18th March 2019.

Project description:BackgroundPeople with pulmonary hypertension (PH) are not routinely referred for exercise rehabilitation despite the potential for reducing breathlessness and improving quality of life. We describe the development of a supervised pulmonary hypertension exercise rehabilitation (SPHERe) programme for people with PH.MethodsDevelopment was completed in three phases: (1) systematic review, (2) stakeholder engagement with consensus from patients and experts and (3) prepilot intervention acceptability testing. We completed systematic reviews to identify international cardiopulmonary rehabilitation guidance and trials of exercise-based interventions for people with PH. Evidence from systematic reviews and stakeholder consensus shaped the SPHERe intervention, including addition of individual behavioural support sessions to promote exercise adherence. The draft SPHERe intervention was ratified through discussions with multidisciplinary professionals and people living with PH. We acceptability tested the centre-based intervention with eight participants in a prepilot development phase which identified a number of condition-specific issues relating to safety and fear avoidance of activity. Comprehensive intervention practitioner training manuals were produced to ensure standardised delivery. Participant workbooks were developed and piloted. Trial recruitment began in January 2020 but was subsequently suspended in March 2020 further to COVID-19 pandemic 'lockdowns'. In response to the pandemic, we undertook further development work to redesign the intervention to be suitable for exclusively home-based online delivery. Recruitment to the revised protocol began in June 2021.DiscussionThe final SPHERe intervention incorporated weekly home-based online group exercise and behavioural support 'coaching' sessions supervised by trained practitioners, with a personalised home exercise plan and the optional loan of a stationary exercise bike. The intervention was fully manualised with clear pathways for assessment and individualised exercise prescription. The clinical and cost-effectiveness of the SPHERe online rehabilitation intervention is currently being tested in a UK multicentre randomised controlled trial.Trial registration numberISCRTN10608766.

Project description:BackgroundRegular exercise is important in the management of COPD. Pulmonary rehabilitation (PR) facilitates a more physically active lifestyle through exercise participation, ideally without compromising non-exercise physical activity (PA). During PR patients are advised to perform exercise defined by duration and intensity. The extent to which PR attendees participate in unsupervised exercise bouts and their adherence to the exercise prescription provided during PR is unclear. Commercially available devices have the potential to support patients to exercise at their individually prescribed intensity. Study aims were to (1) assess how adherent patients are to their prescribed walking intensity; (2) examine the pattern of overall PA and walking exercise during the course of PR; (3) determine the feasibility of prescribing exercise to PR attendees using an activity monitor; and (4) explore the relationship between exercise and non-exercise PA with routine PR outcome measures.Methods19 patients wore an activity monitor during routine walking tests and 6 weeks of PR, recording in a diary when they exercised. Exercise intensity (cadence) was prescribed from the Endurance Shuttle Walk Test. Patients completed questionnaires, walking tests and a lower limb strength test before and after PR. Repeated ANOVA compared changes in outcomes between weeks 1-6.ResultsPatients wore the monitor every day during PR (median 42 days). Exercise steps increased by 56% (Δ332 [95% CI 54-611] steps/day, p = 0.009) between weeks 1 and 6, with no significant change in non-exercise steps (Δ79 [95% CI - 22 to - 179] steps/day, p = 0.13). Patients reported exercising on 70% of days. Adherence to prescribed cadence was achieved 55% of time spent exercising, and did not change across the 6 weeks (p = 0.907). Change in total daily steps was associated with improved dyspnea (p = 0.027), Chronic Respiratory Questionnaire (CRQ) Dyspnea domain (p = 0.019), CRQ Emotional Functioning domain (p = 0.001) and CRQ Mastery domain scores (p = 0.001) but not with exercise capacity or lower limb muscle strength.ConclusionsImprovements in exercise participation, not at the expense of non-exercise PA, throughout a PR course was observed in attendees provided with a commercially available activity monitor. Wearable technology may be able to support effective remote walking exercise prescription and participation during PR. Trial registration (retrospectively registered): http://www.isrctn.com/ISRCTN15892972 .

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An intervention for pulmonary rehabilitators to develop a social identity for patients attending exercise rehabilitation: a feasibility and pilot randomised control trial protocol.

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An intervention for pulmonary rehabilitators to develop a social identity for patients attending exercise rehabilitation: a feasibility and pilot randomised control trial protocol.

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