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).

The venous thrombosis registry in Østfold Hospital (TROLL registry) ‐ design and cohort description

“…Other applications of TROLL include the possibility of identifying and recruiting patients to clinical trials. To date, TROLL has been used to identify and select patients eligible for several clinical studies 8,28,29 …”

Association between myocardial fibrosis, as assessed with cardiac magnetic resonance T1 mapping, and persistent dyspnea after pulmonary embolism

“…This was a single center cross-sectional sub-study of an ongoing project evaluating the effect of pulmonary rehabilitation to improve physical capacity after PE (clinicaltrials.gov - NCT03405480) [29] .…”

Effects of pulmonary rehabilitation on cardiac magnetic resonance parameters in patients with persistent dyspnea following pulmonary embolism

“…This is a sub-study of the ongoing PeRehab study ( clinicaltrials.gov - NCT03405480) [26] . In this sub-study, we examined a cohort of patients with persistent dyspnea after PE with CMR before and after an 8-week pulmonary rehabilitation program.…”

“…Patients performed an outpatient pulmonary rehabilitation program for one hour twice weekly for eight weeks [26] . Experienced physiotherapists developed an individually adapted exercise program for each patient based on individual needs and exercise capacity at baseline, and following training principles of existing pulmonary rehabilitation programs [12] .…”