Erratum to individualised monitoring programme for pulmonary rehabilitation of patients with chronic obstructive pulmonary disease-study protocol for a randomised controlled trial.
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SUBMITTER: Editorial Office
PROVIDER: S-EPMC11320249 | biostudies-literature | 2024 Jul
REPOSITORIES: biostudies-literature
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Erratum to individualised monitoring programme for pulmonary rehabilitation of patients with chronic obstructive pulmonary disease-study protocol for a randomised controlled trial.
Journal of thoracic disease 20240722 7
[This corrects the article DOI: 10.21037/jtd-23-964.]. ...[more]
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Project description: Not available
| S-EPMC10797334 | biostudies-literature
Project description:ObjectiveTo assess the cost-effectiveness of a structured education pulmonary rehabilitation programme (SEPRP) for chronic obstructive pulmonary disease (COPD) relative to usual practice in primary care. The programme consisted of group-based sessions delivered jointly by practice nurses and physiotherapists over 8 weeks.DesignCost-effectiveness and cost-utility analysis alongside a cluster randomised controlled trial.Setting32 general practices in Ireland.Participants350 adults with COPD, 69% of whom were moderately affected.InterventionsIntervention arm (n=178) received a 2 h group-based SEPRP session per week over 8 weeks delivered jointly by a practice nurse and physiotherapist at the practice surgery or nearby venue. The control arm (n=172) received the usual practice in primary care.Main outcome measuresIncremental costs, Chronic Respiratory Questionnaire (CRQ) scores, quality-adjusted life years (QALYs) gained estimated using the generic EQ5D instrument, and expected cost-effectiveness at 22 weeks trial follow-up.ResultsThe intervention was associated with an increase of €944 (95% CIs 489 to 1400) in mean healthcare cost and €261 (95% CIs 226 to 296) in mean patient cost. The intervention was associated with a mean improvement of 1.11 (95% CIs 0.35 to 1.87) in CRQ Total score and 0.002 (95% CIs -0.006 to 0.011) in QALYs gained. These translated into incremental cost-effectiveness ratios of €850 per unit increase in CRQ Total score and €472 000 per additional QALY gained. The probability of the intervention being cost-effective at respective threshold values of €5000, €15 000, €25 000, €35 000 and €45 000 was 0.980, 0.992, 0.994, 0.994 and 0.994 in the CRQ Total score analysis compared to 0.000, 0.001, 0.001, 0.003 and 0.007 in the QALYs gained analysis.ConclusionsWhile analysis suggests that SEPRP was cost-effective if society is willing to pay at least €850 per one-point increase in disease-specific CRQ, no evidence exists when effectiveness was measured in QALYS gained.Trial registrationCurrent Controlled Trials ISRCTN52 403 063.
| S-EPMC3845253 | biostudies-literature
Project description: Not available
| S-EPMC10008021 | biostudies-literature
Project description:IntroductionThere is compelling evidence that either centre-based or home-based pulmonary rehabilitation improves clinical outcomes in chronic obstructive pulmonary disease (COPD). There are known health service and personal barriers which prevent potentially eligible patients from accessing the benefits of pulmonary rehabilitation. The aim of this hybrid effectiveness-implementation trial is to examine the effects of offering patients a choice of pulmonary rehabilitation locations (home or centre) compared with offering only the traditional centre-based model.Method and analysisThis is a two-arm cluster randomised, controlled, assessor-blinded trial of 14 centre-based pulmonary rehabilitation services allocated to intervention (offering choice of home-based or centre-based pulmonary rehabilitation) or control (continuing to offer centre-based pulmonary rehabilitation only), stratified by centre-based programme setting (hospital vs non-hospital). 490 participants with COPD will be recruited. Centre-based pulmonary rehabilitation will be delivered according to best practice guidelines including supervised exercise training for 8 weeks. At intervention sites, the home-based pulmonary rehabilitation will be delivered according to an established 8-week model, comprising of one home visit, unsupervised exercise training and telephone calls that build motivation for exercise participation and facilitate self-management. The primary outcome is all-cause, unplanned hospitalisations in the 12 months following rehabilitation. Secondary outcomes include programme completion rates and measurements of 6-minute walk distance, chronic respiratory questionnaire, EQ-5D-5L, dyspnoea-12, physical activity and sedentary time at the end of rehabilitation and 12 months following rehabilitation.Direct healthcare costs, indirect costs and changes in EQ-5D-5L will be used to evaluate cost-effectiveness. A process evaluation will be undertaken to understand how the choice model is implemented and explore sustainability beyond the clinical trial.Ethics and disseminationAlfred Hospital Ethics Committee has approved this protocol. The trial findings will be published in peer-reviewed journals, submitted for presentation at conferences and disseminated to patients across Australia with support from national lung charities and societies.Trial registration numberNCT04217330.
| S-EPMC9003613 | biostudies-literature
Project description:ObjectiveTo evaluate the effects of an early community based pulmonary rehabilitation programme after hospitalisation for acute exacerbations of chronic obstructive pulmonary disease (COPD).DesignA single centre, randomised controlled trial.SettingAn inner city, secondary and tertiary care hospital in London.Participants42 patients admitted with an acute exacerbation of COPD.InterventionAn eight week, pulmonary rehabilitation programme for outpatients, started within 10 days of hospital discharge, or usual care.Main outcome measuresIncremental shuttle walk distance, disease specific health status (St George's respiratory questionnaire, SGRQ; chronic respiratory questionnaire, CRQ) and generic health status (medical outcomes short form 36 questionnaire, SF-36) at three months after hospital discharge.ResultsEarly pulmonary rehabilitation, compared with usual care, led to significant improvements in median incremental shuttle walk distance (60 metres, 95% confidence interval 26.6 metres to 93.4 metres, P = 0.0002), mean SGRQ total score (-12.7, -5.0 to -20.3, P = 0.002), all four domains of the CRQ (dyspnoea 5.5, 2.0 to 9.0, P = 0.003; fatigue 5.3, 1.9 to 8.8, P = 0.004; emotion 8.7, 2.4 to 15.0, P = 0.008; and mastery 7.5, 4.2 to 10.7, P < 0.001) and the mental component score of the SF-36 (20.1, 3.3 to 36.8, P = 0.02). Improvements in the physical component score of the SF-36 did not reach significance (10.6, -0.3 to 21.6, P = 0.057).ConclusionEarly pulmonary rehabilitation after admission to hospital for acute exacerbations of COPD is safe and leads to statistically and clinically significant improvements in exercise capacity and health status at three months.
| S-EPMC529363 | biostudies-literature
Project description: Not available
| S-EPMC6463852 | biostudies-literature
Project description:ObjectiveTo obtain evidence whether the online pulmonary rehabilitation(PR) programme 'my-PR' is non-inferior to a conventional face-to-face PR in improving physical performance and symptom scores in patients with COPD.DesignA two-arm parallel single-blind, randomised controlled trial.SettingThe online arm carried out pulmonary rehabilitation in their own homes and the face to face arm in a local rehabilitation facility.Participants90 patients with a diagnosis of chronic obstructive pulmonary disease (COPD), modified Medical Research Council score of 2 or greater referred for pulmonary rehabilitation (PR), randomised in a 2:1 ratio to online (n=64) or face-to-face PR (n=26). Participants unable to use an internet-enabled device at home were excluded.Main outcome measuresCoprimary outcomes were 6 min walk distance test and the COPD assessment test (CAT) score at completion of the programme.InterventionsA 6-week PR programme organised either as group sessions in a local rehabilitation facility, or online PR via log in and access to 'myPR'.ResultsThe adjusted mean difference for the 6 min walk test (6MWT) between groups for the intention-to-treat (ITT) population was 23.8 m with the lower 95% CI well above the non-inferiority threshold of -40.5 m at -4.5 m with an upper 95% CI of +52.2 m. This result was consistent in the per-protocol (PP) population with a mean adjusted difference of 15 m (-13.7 to 43.8). The CAT score difference in the ITT was -1.0 in favour of the online intervention with the upper 95% CI well below the non-inferiority threshold of 1.8 at 0.86 and the lower 95% CI of -2.9. The PP analysis was consistent with the ITT.ConclusionPR is an evidenced-based and guideline-mandated intervention for patients with COPD with functional limitation. A 6-week programme of online-supported PR was non-inferior to a conventional model delivered in face-to-face sessions in terms of effects on 6MWT distance, and symptom scores and was safe and well tolerated.
| S-EPMC5541506 | biostudies-literature
Project description:ObjectivesTo assess the feasibility of delivering a culturally tailored pulmonary rehabilitation (PR) programme and conducting a definitive randomised controlled trial (RCT).DesignA two-arm, randomised feasibility trial with a mixed-methods process evaluation.SettingSecondary care setting in Georgia, Europe.ParticipantsPeople with symptomatic spirometry-confirmed chronic obstructive pulmonary disease recruited from primary and secondary care.InterventionsParticipants were randomised in a 1:1 ratio to a control group or intervention comprising 16 twice-weekly group PR sessions tailored to the Georgian setting.Primary and secondary outcome measuresFeasibility of the intervention and RCT were assessed according to: study recruitment, consent and follow-up, intervention fidelity, adherence and acceptability, using questionnaires and measurements at baseline, programme end and 6 months, and through qualitative interviews.ResultsThe study recruited 60 participants (as planned): 54 (90%) were male, 10 (17%) had a forced expiratory volume in 1 second of ≤50% predicted. The mean MRC Dyspnoea Score was 3.3 (SD 0.5), and mean St George's Respiratory Questionnaire (SGRQ) 50.9 (SD 17.6). The rehabilitation specialists delivered the PR with fidelity. Thirteen (43.0%) participants attended at least 75% of the 16 planned sessions. Participants and rehabilitation specialists in the qualitative interviews reported that the programme was acceptable, but dropout rates were high in participants who lived outside Tbilisi and had to travel large distances. Outcome data were collected on 63.3% participants at 8 weeks and 88.0% participants at 6 months. Mean change in SGRQ total was -24.9 (95% CI -40.3 to -9.6) at programme end and -4.4 (95% CI -12.3 to 3.4) at 6 months follow-up for the intervention group and -0.5 (95% CI -8.1 to 7.0) and -8.1 (95% CI -16.5 to 0.3) for the usual care group at programme end and 6 months, respectively.ConclusionsIt was feasible to deliver the tailored PR intervention. Approaches to improve uptake and adherence warrant further research.Trial registration numberISRCTN16184185.
| S-EPMC9511586 | biostudies-literature
Project description:IntroductionAdults with chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) commonly suffer from exertional dyspnoea and fatigue. Exercise training is recommended in the management of both diseases, yet many of the outcome measures traditionally reported are disease specific and may not fully acknowledge the multimorbid older adult. Based on our previous research, a breathlessness rehabilitation programme for patients with COPD/CHF or combined disease has been introduced as a service improvement within University Hospital Leicester National Health Service Trust and has amalgamated aspects of cardiac and pulmonary rehabilitation. This has created an opportunity to expand the outcome measures assessed and introduce a holistic approach in a population that share common symptoms. Therefore, this multisite trial will explore the feasibility of collecting novel outcome markers as part of a comprehensive assessment prior to enrolment in a breathlessness rehabilitation programme for participants with COPD and/or CHF.Methods and analysisThe rehabilitation programme consists of 12 sessions, twice weekly, over a 6-week period. In addition to usual rehabilitation outcome measures, the trial will collect measures of future cardiometabolic risk including arterial stiffness, body composition, physical activity/sedentary time, frailty and symptom burden in a comprehensive rehabilitation assessment. The primary outcome measures will centre around feasibility (eg, acceptability of the comprehensive rehabilitation assessment, intervention delivery and the experiences and attitudes of healthcare professionals and participants). Focus groups and interviews will be conducted to further explore barriers and facilitators to the operation and participation in a breathlessness rehabilitation programme and the trial. Thematic analysis will be used for the interpretation of all qualitative data.Ethics and disseminationThe research ethics committee East Midlands Leicester-Central has provided ethical approval for the conduct of this trial. The results of the trial will be disseminated through appropriate conference proceedings and peer-reviewed journals.Trial registration numberISRCTN11636308.
| S-EPMC6661899 | biostudies-literature
Project description:To evaluate the impact of participant-selected music listening as an adjunct to pulmonary rehabilitation (PR) in people with COPD. Adults with COPD referred to PR were randomly assigned to participant-selected music listening (intervention group, [IG]) or usual care (control group [CG]) during an 8-weeks PR program. Prior to training, the IG completed an interview with a registered music therapist to identify music preferences. IG participants listened to an individualised playlist; CG participants had usual care. Primary outcomes included end-6-min walk test symptoms (dyspnoea and exertion) and dyspnoea (Multidimensional Dyspnoea Profile [MDP]), measured pre and post PR and 6-months follow-up. 58 participants, FEV1 52.4 (25.9)% pd) were recruited. There were no between-group differences following the intervention (p > .05 for all outcomes at all time points). Within-group differences following PR were significant for MDP sensory quality: IG mean difference [95% CI] -2.2 [-3.3 to -1.2]; CG -1.5 [-2.5 to -0.5] points; MDP emotional response: IG -3.2 [-4.2 to -2.3]; CG -2.2 [-3.2 to -1.3] points). Participant-selected music listening during PR offered no greater benefit to symptoms of dyspnoea or exertion compared to usual care. With the study limited by COVID-19 restrictions, the role of this adjunct remains to be clarified.
| S-EPMC11457285 | biostudies-literature