Stacey Haukeland-Parker1,2, Øyvind Jervan3,4, Hege Hølmo Johannessen5,6, Jostein Gleditsch3,7, Knut Stavem3,8,9, Kjetil Steine3,10, Martijn A Spruit11,12,13, René Holst3,4, Mazdak Tavoly4,14, Frederikus A Klok15, Waleed Ghanima3,16. 1. Department of Physical Medicine and Rehabilitation, Østfold Hospital Trust, PB 300, 1714, Grålum, Norway. stacey.haukeland.parker@so-hf.no. 2. Oslo Centre for Biostatistics and Epidemiology, Institute of Basic Medicine, University of Oslo, Oslo University Hospital, Oslo, Norway. stacey.haukeland.parker@so-hf.no. 3. Oslo Centre for Biostatistics and Epidemiology, Institute of Basic Medicine, University of Oslo, Oslo University Hospital, Oslo, Norway. 4. Department of Internal Medicine, Østfold Hospital Trust (number 3), Grålum, Norway. 5. Department of Physical Medicine and Rehabilitation, Østfold Hospital Trust, PB 300, 1714, Grålum, Norway. 6. Department of Health and Welfare, Østfold University College, Fredrikstad, Norway. 7. Department of Radiology, Østfold Hospital Trust, Grålum, Norway. 8. Department of Pulmonary Medicine, Medical Division, Akershus University Hospital, Lørenskog, Norway. 9. Health Services Research Unit, Akershus University Hospital, Lørenskog, Norway. 10. Department of Cardiology, Medical Division, Akershus University Hospital, Lørenskog, Norway. 11. Department of Research and Development, CIRO+, Horn, The Netherlands. 12. Department of Respiratory Medicine, Maastricht University Medical Center (MUMC+), and NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands. 13. REVAL Rehabilitation Research Center, BIOMED Biomedical Research Institute, Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium. 14. Department of Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden. 15. Department of Medicine - Thrombosis and Haemostasis, Leiden University Medical Center, Leiden, The Netherlands. 16. Departments of Research, Emergency Medicine and Hematooncology, Østfold Hospital Trust, Grålum, Norway.
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).
RCT Entities:
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 PPSpatients. 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 PPSpatients 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).
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