TY - JOUR
T1 - 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
AU - Haukeland-Parker, S.
AU - Jervan, O.
AU - Johannessen, H.H.
AU - Gleditsch, J.
AU - Stavem, K.
AU - Steine, K.
AU - Spruit, M.A.
AU - Holst, R.
AU - Tavoly, M.
AU - Klok, F.A.
AU - Ghanima, W.
N1 - Funding Information:
This study is funded by ØHT. The funding body’s role is to contribute and support the design of the study, the collection, analysis, and interpretation of data, and several authors from ØHT are involved in writing the manuscript.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/1/6
Y1 - 2021/1/6
N2 - BackgroundRecently, 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.MethodsA two-center randomized controlled trial (RCT) is being performed at Ostfold 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 (1h) for 8weeks 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, 12weeks, and 36weeks 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.DiscussionResults 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 registrationClinical 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).
AB - BackgroundRecently, 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.MethodsA two-center randomized controlled trial (RCT) is being performed at Ostfold 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 (1h) for 8weeks 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, 12weeks, and 36weeks 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.DiscussionResults 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 registrationClinical 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).
KW - Dyspnea
KW - Exercise capacity
KW - Pulmonary embolism
KW - Quality of life
KW - Randomized controlled trial
KW - Rrehabilitation
KW - dyspnea
KW - exercise capacity
KW - pulmonary embolism
KW - quality of life
KW - randomized controlled trial
KW - rrehabilitation
KW - SAFETY
KW - EPISODE
KW - CLINICALLY IMPORTANT IMPROVEMENT
KW - VENOUS THROMBOEMBOLISM
KW - SHUTTLE WALK TEST
KW - DISEASE
U2 - 10.1186/s13063-020-04940-9
DO - 10.1186/s13063-020-04940-9
M3 - Article
C2 - 33407792
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 22
ER -