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Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial.

ABSTRACT: RATIONALE:Pulmonary rehabilitation (PR) is an effective, key standard treatment for people with COPD. Nevertheless, low participant uptake, insufficient attendance and high drop-out rates are reported. Investigation is warranted of the benefits achieved through alternative approaches, such as pulmonary tele-rehabilitation (PTR). OBJECTIVE:To investigate whether PTR is superior to conventional PR on 6?min walk distance (6MWD) and secondarily on respiratory symptoms, quality of life, physical activity and lower limb muscle function in patients with COPD and FEV1 <50% eligible for routine hospital-based, outpatient PR. METHODS:In this single-blinded, multicentre, superiority randomised controlled trial, patients were assigned 1:1 to 10 weeks of groups-based PTR (60?min, three times weekly) or conventional PR (90?min, two times weekly). Assessments were performed by blinded assessors at baseline, end of intervention and at 22 weeks' follow-up from baseline. The primary analysis was based on the intention-to-treat principle. MEASUREMENTS AND MAIN RESULTS:The primary outcome was change in 6MWD from baseline to 10 weeks; 134 participants (74 females, mean±SD?age 68±9 years, FEV1 33%±9% predicted, 6MWD 327±103 metres) were included and randomised. The analysis showed no between-group differences for changes in 6MWD after intervention (9.2 metres (95%?CI: -6.6 to 24.9)) or at 22 weeks' follow-up (-5.3 metres (95%?CI: -28.9 to 18.3)). More participants completed the PTR intervention (n=57) than conventional PR (n=43) (?2 test p<0.01). CONCLUSION:PTR was not superior to conventional PR on the 6MWD and we found no differences between groups. As more participants completed PTR, supervised PTR would be relevant to compare with conventional PR in a non-inferiority design. Trial registration number ClinicalTrials.gov (NCT02667171), 28 January 2016.

SUBMITTER: Hansen H

PROVIDER: S-EPMC7231436 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial.

Hansen Henrik H Bieler Theresa T Beyer Nina N Kallemose Thomas T Wilcke Jon Torgny JT Østergaard Lisbeth Marie LM Frost Andeassen Helle H Martinez Gerd G Lavesen Marie M Frølich Anne A Godtfredsen Nina Skavlan NS

Thorax 20200330 5

<h4>Rationale</h4>Pulmonary rehabilitation (PR) is an effective, key standard treatment for people with COPD. Nevertheless, low participant uptake, insufficient attendance and high drop-out rates are reported. Investigation is warranted of the benefits achieved through alternative approaches, such as pulmonary tele-rehabilitation (PTR).<h4>Objective</h4>To investigate whether PTR is superior to conventional PR on 6 min walk distance (6MWD) and secondarily on respiratory symptoms, quality of life ...[more]

PMID: 32229541

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Project description:BackgroundPulmonary tele-rehabilitation can improve adherence to pulmonary rehabilitation. However, there are few reports on home based pulmonary tele-rehabilitation. We assessed the effectiveness of home based pulmonary tele-rehabilitation under telemedicine system in patients with chronic obstructive pulmonary disease (COPD).MethodsThis cohort study enrolled 174 patients with COPD who received home based pulmonary tele-rehabilitation under telemedicine system. The follow-up time was 12 weeks. Patients were grouped according to pulmonary rehabilitation weeks, number of rehabilitation times and total duration time, and when these three data were inconsistent, the two lowest values were grouped: control group (total rehabilitation weeks < 1 week, total number of rehabilitation times < 5, total duration time < 150 min, n = 46), pulmonary rehabilitation group 1 (PR-1) (1 week ≤ rehabilitation weeks < 4 weeks, 5 ≤ total number of rehabilitation times < 20, 150 min ≤ total duration time < 1200 min, n = 31), pulmonary rehabilitation group 2 (PR-2) (4 weeks ≤ rehabilitation weeks < 8 weeks, 20 ≤ total number of rehabilitation times < 40, 600 min ≤ total duration time < 2400 min, n = 23), pulmonary rehabilitation group 3 (PR-3) (8 weeks ≤ rehabilitation weeks < 12 weeks, 40 ≤ total number of rehabilitation times < 60, 1200 min ≤ total duration time < 3600 min, n = 40) and pulmonary rehabilitation group 4 (PR-4) (rehabilitation weeks = 12 weeks, total number of rehabilitation times = 60, total duration time = 3600 min, n = 34). The clinical data before and after rehabilitation were collected and evaluated, including dyspnea symptoms, 6-min walk distance (6MWD), diaphragmatic mobility, anxiety and depression.ResultsThere was no significance difference between control group and PR-1 group. PR-2 group after rehabilitation had significantly decreased CAT and HAMA scores than control (P < 0.05). Compared with control, PR-3 group and PR-4 group after rehabilitation had significantly higher 6MWD and diaphragmatic motility during deep breathing, but significantly lower CAT score, mMRC score, HAMA score, and HAMD score (P < 0.05). Compared with before pulmonary rehabilitation, in PR-3 and PR-4 groups, the 6MWD and the diaphragmatic motility during deep breathing were significantly higher, while CAT score, mMRC score, HAMA score, and HAMD score (for PR-4 only) were significantly lower after pulmonary rehabilitation (P < 0.05). There was no significant difference between PR-3 group and PR-4 group (P > 0.05). In the 12-week pulmonary rehabilitation program, patients who completed at least 8 weeks, namely those in the PR-3 and PR-4 groups, accounted for 42.5% of the total number. Education, income and response rate to telemedicine system reminders were the main risk factors associated with home based pulmonary tele-rehabilitation.ConclusionsHome based pulmonary tele-rehabilitation under telemedicine system for more than 8 weeks can significantly improve the dyspnea symptoms, 6MWD, diaphragmatic mobility during deep breathing, and negative emotions of patients with moderate to severe stable COPD.Trial registrationThis study was registered at Chinese Clinical Trial Registry under registration number of ChiCTR2200056241 CTR2200056241 .

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:BackgroundAcute exacerbations of chronic obstructive pulmonary disease (COPD) lead to a significant reduction in quality of life and an increased mortality risk. Current guidelines strongly recommend pulmonary rehabilitation (PR) after a severe exacerbation. Studies reporting referral for PR are scarce, with no report to date in Europe. Therefore, we assessed the proportion of French patients receiving PR after hospitalization for COPD exacerbation and factors associated with referral.MethodsThis was a national retrospective study based on the French health insurance database. Patients hospitalized in 2017 with COPD exacerbation were identified from the exhaustive French medico-administrative database of hospitalizations. In France, referral to PR has required as a stay in a specialized PR center or unit accredited to provide multidisciplinary care (exercise training, education, etc.) and admission within 90 days after discharge was assessed. Multivariate logistic regression was used to assess the association between patients' characteristics, comorbidities according to the Charlson index, treatment, and PR uptake.ResultsAmong 48,638 patients aged ≥ 40 years admitted for a COPD exacerbation, 4,182 (8.6%) received PR within 90 days after discharge. General practitioner's (GP) density (number of GPs for the population at regional level) and PR center facilities (number of beds for the population at regional level) were significantly correlated with PR uptake (respectively r = 0.64 and r = 0.71). In multivariate analysis, variables independently associated with PR uptake were female gender (aOR 1.36 [1.28-1.45], p < 0.0001), age (p < 0.0001), comorbidities (p = 0.0013), use of non-invasive ventilation and/or oxygen therapy (aOR 1.52 [1.41-1.64], p < 0.0001) and administration of long-acting bronchodilators (p = 0.0038).ConclusionThis study using the French nationally exhaustive health insurance database shows that PR uptake after a severe COPD exacerbation is dramatically low and must become a high-priority management strategy.

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.

Project description:Absence of pulmonary perfusion during cardiopulmonary bypass (CPB) may be associated with reduced postoperative oxygenation. Effects of active pulmonary artery perfusion were explored in patients with chronic obstructive pulmonary disease (COPD) undergoing cardiac surgery.90 patients were randomised to receive pulmonary artery perfusion during CPB with either oxygenated blood (n=30) or histidine-tryptophan-ketoglutarate (HTK) solution (n=29) compared with no pulmonary perfusion (n=31). The coprimary outcomes were the inverse oxygenation index compared at 21?hours after starting CPB and longitudinally in a mixed-effects model (MEM). Secondary outcomes were tracheal intubation time, serious adverse events, mortality, days alive outside the intensive care unit (ICU) and outside the hospital.21?hours after starting CPB patients receiving pulmonary artery perfusion with normothermic oxygenated blood had a higher oxygenation index compared with no pulmonary perfusion (mean difference (MD) 0.94; 95% CI 0.05 to 1.83; p=0.04). The blood group had also a higher oxygenation index both longitudinally (MEM, p=0.009) and at 21?hours (MD 0.99; CI 0.29 to 1.69; p=0.007) compared with the HTK group. The latest result corresponds to a difference in the arterial partial pressure of oxygen of 23?mm?Hg with a median fraction of inspired oxygen of 0.32. Yet the blood or HTK groups did not demonstrate a longitudinally higher oxygenation index compared with no pulmonary perfusion (MEM, p=0.57 and 0.17). Similarly, at 21?hours there was no difference in the oxygenation index between the HTK group and those no pulmonary perfusion (MD 0.06; 95% CI -0.73 to 0.86; p=0.87). There were no statistical significant differences between the groups for the secondary outcomes.Pulmonary artery perfusion with normothermic oxygenated blood during cardiopulmonary bypass appears to improve postoperative oxygenation in patients with COPD undergoing cardiac surgery. Pulmonary artery perfusion with hypothermic HTK solution does not seem to improve postoperative oxygenation.NCT01614951; Pre-results.

Dataset Information

Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial.

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Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial.

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