Dataset Information

Pulmonary rehabilitation to improve physical capacity, dyspnea, and quality of life following pulmonary embolism (the PeRehab study): study protocol for a two-center randomized controlled trial.

ABSTRACT:

Background

Recently, a large group of patients with persistent dyspnea, poor physical capacity, and reduced health-related quality of life (HRQoL) following pulmonary embolism (PE) has been identified and clustered under the name "post pulmonary embolism syndrome" (PPS). These patients seem good candidates for pulmonary rehabilitation. The aim of the study is to explore whether a pulmonary rehabilitation program can improve physical capacity, dyspnea, and HRQoL in PPS patients.

Methods

A two-center randomized controlled trial (RCT) is being performed at Østfold Hospital and Akershus University Hospital in Norway. Patients with PPS are 1:1 randomized into an intervention or a control group. The intervention consists of a supervised, outpatient rehabilitation program twice weekly (1?h) for 8?weeks provided by experienced physiotherapists. The intervention involves individually adapted exercises based on existing pulmonary rehabilitation programs (relaxation, interval, and resistance training), and an educational session including topics such as normal anatomy and physiology of the respiratory and circulatory system, information on PE/PPS, breathing strategies, and benefits of exercise/physical activity. Patients randomized to the control group receive usual care without specific instructions to exercise. Participants in the intervention and control groups will be compared based on assessments conducted at baseline, 12?weeks, and 36?weeks after inclusion using the incremental shuttle walk test (primary outcome) and endurance shuttle walk test (exercise capacity), Sensewear activity monitor (daily physical activity), the modified Medical Research Council scale, the Shortness of Breath Questionnaire (dyspnea), and EQ-5D-5L and the Pulmonary Embolism Quality of Life Questionnaire (HRQoL). Recruitment of 190 patients is currently ongoing.

Discussion

Results from this study may provide a currently untreated group of PPS patients with an effective treatment resulting in reduced symptoms of dyspnea, improved exercise capacity, and better HRQoL following PE.

Trial registration

Clinical Trials NCT03405480 . Registered prospectively on September 2017. Protocol version 1 (from original protocol September 2017). The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 1).

SUBMITTER: Haukeland-Parker S

PROVIDER: S-EPMC7789311 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Pulmonary rehabilitation to improve physical capacity, dyspnea, and quality of life following pulmonary embolism (the PeRehab study): study protocol for a two-center randomized controlled trial.

Haukeland-Parker Stacey S Jervan Øyvind Ø Johannessen Hege Hølmo HH Gleditsch Jostein J Stavem Knut K Steine Kjetil K Spruit Martijn A MA Holst René R Tavoly Mazdak M Klok Frederikus A FA Ghanima Waleed W

Trials 20210106 1

<h4>Background</h4>Recently, a large group of patients with persistent dyspnea, poor physical capacity, and reduced health-related quality of life (HRQoL) following pulmonary embolism (PE) has been identified and clustered under the name "post pulmonary embolism syndrome" (PPS). These patients seem good candidates for pulmonary rehabilitation. The aim of the study is to explore whether a pulmonary rehabilitation program can improve physical capacity, dyspnea, and HRQoL in PPS patients.<h4>Method ...[more]

PMID: 33407792

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Project description:BackgroundCOVID-19 survivors face the risk of long-term sequelae including fatigue, breathlessness, and functional limitations. Pulmonary rehabilitation has been recommended, although formal studies quantifying the effect of rehabilitation in COVID-19 patients are lacking.MethodsWe conducted a prospective observational cohort study including consecutive patients admitted to an outpatient pulmonary rehabilitation center due to persistent symptoms after COVID-19. The primary endpoint was change in 6-min walk distance (6MWD) after undergoing a 6-week interdisciplinary individualized pulmonary rehabilitation program. Secondary endpoints included change in the post-COVID-19 functional status (PCFS) scale, Borg dyspnea scale, Fatigue Assessment Scale, and quality of life. Further, changes in pulmonary function tests were explored.ResultsOf 64 patients undergoing rehabilitation, 58 patients (mean age 47 years, 43% women, 38% severe/critical COVID-19) were included in the per-protocol-analysis. At baseline (i.e., in mean 4.4 months after infection onset), mean 6MWD was 584.1 m (±95.0), and functional impairment was graded in median at 2 (IQR, 2-3) on the PCFS. On average, patients improved their 6MWD by 62.9 m (±48.2, p < 0.001) and reported an improvement of 1 grade on the PCFS scale. Accordingly, we observed significant improvements across secondary endpoints including presence of dyspnea (p < 0.001), fatigue (p < 0.001), and quality of life (p < 0.001). Also, pulmonary function parameters (forced expiratory volume in 1 s, lung diffusion capacity, inspiratory muscle pressure) significantly increased during rehabilitation.ConclusionIn patients with long COVID, exercise capacity, functional status, dyspnea, fatigue, and quality of life improved after 6 weeks of personalized interdisciplinary pulmonary rehabilitation. Future studies are needed to establish the optimal protocol, duration, and long-term benefits as well as cost-effectiveness of rehabilitation.

Project description:Pulmonary embolism (PE) is a major cause of cardiovascular morbidity and mortality. Recent hospitalization or surgery is a leading risk factor for PE, yet there are minimal data examining its effect on treatment and outcomes. We conducted a retrospective review of institutional billing codes for hospitalized patients with acute PE from August 2012 to August 2018. Patients were stratified based on whether they had a recent major medical encounter (MME), defined as surgery or hospitalization within 90 days. Primary outcomes included in-hospital mortality and 30- and 90-day readmission rates. Secondary outcomes included length of stay (LOS), use of advanced therapies, major bleeding, discharge anticoagulation and recurrent venous thromboembolism (VTE) at 90 days. Outcomes were adjusted for confounders using multivariable regression modeling. 2063 patients were hospitalized for an acute PE; 633 (30.7%) had a recent MME. Patients with a recent MME had a higher average Charlson Comorbidity Index (4.6 vs. 4.0, p < 0.01). Both 30- and 90-day readmission rates were higher in patients with a recent MME (21.7% vs. 14.4%; adjusted OR 1.06 [1.00, 1.12], p = 0.037; 30.8% vs 18.7%; adjusted OR 1.11 [1.11, 1.62], p = 0.003, respectively). After adjustment, there were no between-group differences in in-hospital mortality, LOS, use of advanced therapies, major bleeding, or recurrent VTE at 90 days. In-hospital mortality was higher for patients with a recent medical hospitalization compared to those with a recent surgery (10.2% vs. 5.6%, adjusted OR 1.08 [1.01, 1.15] p = 0.032). Despite recent hospitalization and/or surgery and greater number of comorbidities, patients admitted with a PE and recent MME had similar in-hospital outcomes, but experienced higher readmission rates. In-hospital mortality was higher in those with a recent medical compared to surgical encounter. Clinicians should optimize post-discharge transitional care in this subset of patients.

Dataset Information

Pulmonary rehabilitation to improve physical capacity, dyspnea, and quality of life following pulmonary embolism (the PeRehab study): study protocol for a two-center randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Pulmonary rehabilitation to improve physical capacity, dyspnea, and quality of life following pulmonary embolism (the PeRehab study): study protocol for a two-center randomized controlled trial.

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