Effect of a Physiotherapist-Guided Home-Based Exercise Intervention on Physical Capacity and Patient-Reported Outcomes Among Patients With Acute Pulmonary Embolism: A Randomized Clinical Trial

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Effect of a Physiotherapist-Guided Home-Based Exercise Intervention on Physical Capacity and Patient-Reported Outcomes Among Patients With Acute Pulmonary Embolism : A Randomized Clinical Trial. / Rolving, Nanna; Brocki, Barbara C.; Bloch-Nielsen, Jannie R.; Larsen, Torben B.; Jensen, Frank L.; Mikkelsen, Hanne R.; Ravn, Pernille; Frost, Lars.

I: JAMA network open, Bind 3, Nr. 2, e200064, 2020.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

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@article{c94e21e3e5c445b982957733e70554a8,
title = "Effect of a Physiotherapist-Guided Home-Based Exercise Intervention on Physical Capacity and Patient-Reported Outcomes Among Patients With Acute Pulmonary Embolism: A Randomized Clinical Trial",
abstract = "Importance: Survivors of acute pulmonary embolism (PE) experience long-term negative physical and mental consequences, but the effects of rehabilitation on outcomes among these patients have not been investigated. Objective: To investigate the effect of a rehabilitation intervention, comprising an 8-week home-based exercise program and nurse consultations, on physical capacity and patient-reported outcomes among patients with acute PE. Design, Setting, and Participants: This multicenter randomized clinical superiority trial was conducted at 4 regional hospitals and 1 university hospital in Denmark. The 140 consecutively included participants had been diagnosed with an acute PE between April 2016 and February 2018 and had 6 months of follow-up. An intention-to-treat analysis was conducted. Intervention: Patients in the control group received a brief nurse consultation, while patients in the exercise group participated in an 8-week home-based exercise program in addition to receiving nurse consultations. Main Outcomes and Measures: The primary outcome was the Incremental Shuttle Walk Test, and secondary outcomes were the Pulmonary Embolism Quality of Life and the EuroQol-5 Dimensions-3 Levels questionnaires, self-reported number of sick-leave days, and self-reported use of psychotropic drugs. Results: A total of 140 patients (90 [64.3%] men) were included, with a mean (SD) age of 61 (11) years. Of 70 participants (50.0%) randomized to each group, 69 participants (49.3%) received the intervention and 68 (48.6%) received the control intervention. Both groups achieved improvements in all outcomes (eg, mean [SD] improvement on Incremental Shuttle Walk Test: control group, 78 (127) m; intervention group, 104 [106] m; median [interquartile range] improvement on Pulmonary Embolism Quality of Life: control group, -17 [-22 to -11] points; intervention group, -20 [-24 to -15] points). Between-group differences were nonsignificant. The mean differences between the intervention group and the control group were 25 m (95% CI, -20 to 70 m; P = .27) on the Incremental Shuttle Walk Test, 3.0 points (95% CI, -3.7 to 9.9 points; P = .39) on the Pulmonary Embolism Quality of Life questionnaire, and 0.017 point (95% CI, -0.032 to 0.065 point; P = .50) on the EuroQol-5 Dimensions-3 Levels questionnaire. Of the 27 patients in the intervention group on sick leave at baseline, 24 (88.9%) reported fit-for-duty at the 6-month follow-up, and of 18 patients in the control group on sick leave, 17 (94.4%) reported fit-for-duty at the 6-month follow up. The between-group risk difference was not significant (5.5 points; P = .49). Conclusions and Relevance: An 8-week rehabilitation intervention with exercise added to nurse consultations did not show significantly better outcomes than nurse consultations alone. However, because of a ceiling effect on the primary outcome of physical capacity and an inclusion of patients with a low comorbidity burden and low PE disease severity, definitive conclusions could not be drawn. Initiating an exercise intervention shortly after pulmonary embolism was safe and without adverse events. Trial Registration: ClinicalTrials.gov Identifier: NCT02684721.",
author = "Nanna Rolving and Brocki, {Barbara C.} and Bloch-Nielsen, {Jannie R.} and Larsen, {Torben B.} and Jensen, {Frank L.} and Mikkelsen, {Hanne R.} and Pernille Ravn and Lars Frost",
year = "2020",
doi = "10.1001/jamanetworkopen.2020.0064",
language = "English",
volume = "3",
journal = "JAMA Network Open",
issn = "2574-3805",
publisher = "American Medical Association",
number = "2",

}

RIS

TY - JOUR

T1 - Effect of a Physiotherapist-Guided Home-Based Exercise Intervention on Physical Capacity and Patient-Reported Outcomes Among Patients With Acute Pulmonary Embolism

T2 - A Randomized Clinical Trial

AU - Rolving, Nanna

AU - Brocki, Barbara C.

AU - Bloch-Nielsen, Jannie R.

AU - Larsen, Torben B.

AU - Jensen, Frank L.

AU - Mikkelsen, Hanne R.

AU - Ravn, Pernille

AU - Frost, Lars

PY - 2020

Y1 - 2020

N2 - Importance: Survivors of acute pulmonary embolism (PE) experience long-term negative physical and mental consequences, but the effects of rehabilitation on outcomes among these patients have not been investigated. Objective: To investigate the effect of a rehabilitation intervention, comprising an 8-week home-based exercise program and nurse consultations, on physical capacity and patient-reported outcomes among patients with acute PE. Design, Setting, and Participants: This multicenter randomized clinical superiority trial was conducted at 4 regional hospitals and 1 university hospital in Denmark. The 140 consecutively included participants had been diagnosed with an acute PE between April 2016 and February 2018 and had 6 months of follow-up. An intention-to-treat analysis was conducted. Intervention: Patients in the control group received a brief nurse consultation, while patients in the exercise group participated in an 8-week home-based exercise program in addition to receiving nurse consultations. Main Outcomes and Measures: The primary outcome was the Incremental Shuttle Walk Test, and secondary outcomes were the Pulmonary Embolism Quality of Life and the EuroQol-5 Dimensions-3 Levels questionnaires, self-reported number of sick-leave days, and self-reported use of psychotropic drugs. Results: A total of 140 patients (90 [64.3%] men) were included, with a mean (SD) age of 61 (11) years. Of 70 participants (50.0%) randomized to each group, 69 participants (49.3%) received the intervention and 68 (48.6%) received the control intervention. Both groups achieved improvements in all outcomes (eg, mean [SD] improvement on Incremental Shuttle Walk Test: control group, 78 (127) m; intervention group, 104 [106] m; median [interquartile range] improvement on Pulmonary Embolism Quality of Life: control group, -17 [-22 to -11] points; intervention group, -20 [-24 to -15] points). Between-group differences were nonsignificant. The mean differences between the intervention group and the control group were 25 m (95% CI, -20 to 70 m; P = .27) on the Incremental Shuttle Walk Test, 3.0 points (95% CI, -3.7 to 9.9 points; P = .39) on the Pulmonary Embolism Quality of Life questionnaire, and 0.017 point (95% CI, -0.032 to 0.065 point; P = .50) on the EuroQol-5 Dimensions-3 Levels questionnaire. Of the 27 patients in the intervention group on sick leave at baseline, 24 (88.9%) reported fit-for-duty at the 6-month follow-up, and of 18 patients in the control group on sick leave, 17 (94.4%) reported fit-for-duty at the 6-month follow up. The between-group risk difference was not significant (5.5 points; P = .49). Conclusions and Relevance: An 8-week rehabilitation intervention with exercise added to nurse consultations did not show significantly better outcomes than nurse consultations alone. However, because of a ceiling effect on the primary outcome of physical capacity and an inclusion of patients with a low comorbidity burden and low PE disease severity, definitive conclusions could not be drawn. Initiating an exercise intervention shortly after pulmonary embolism was safe and without adverse events. Trial Registration: ClinicalTrials.gov Identifier: NCT02684721.

AB - Importance: Survivors of acute pulmonary embolism (PE) experience long-term negative physical and mental consequences, but the effects of rehabilitation on outcomes among these patients have not been investigated. Objective: To investigate the effect of a rehabilitation intervention, comprising an 8-week home-based exercise program and nurse consultations, on physical capacity and patient-reported outcomes among patients with acute PE. Design, Setting, and Participants: This multicenter randomized clinical superiority trial was conducted at 4 regional hospitals and 1 university hospital in Denmark. The 140 consecutively included participants had been diagnosed with an acute PE between April 2016 and February 2018 and had 6 months of follow-up. An intention-to-treat analysis was conducted. Intervention: Patients in the control group received a brief nurse consultation, while patients in the exercise group participated in an 8-week home-based exercise program in addition to receiving nurse consultations. Main Outcomes and Measures: The primary outcome was the Incremental Shuttle Walk Test, and secondary outcomes were the Pulmonary Embolism Quality of Life and the EuroQol-5 Dimensions-3 Levels questionnaires, self-reported number of sick-leave days, and self-reported use of psychotropic drugs. Results: A total of 140 patients (90 [64.3%] men) were included, with a mean (SD) age of 61 (11) years. Of 70 participants (50.0%) randomized to each group, 69 participants (49.3%) received the intervention and 68 (48.6%) received the control intervention. Both groups achieved improvements in all outcomes (eg, mean [SD] improvement on Incremental Shuttle Walk Test: control group, 78 (127) m; intervention group, 104 [106] m; median [interquartile range] improvement on Pulmonary Embolism Quality of Life: control group, -17 [-22 to -11] points; intervention group, -20 [-24 to -15] points). Between-group differences were nonsignificant. The mean differences between the intervention group and the control group were 25 m (95% CI, -20 to 70 m; P = .27) on the Incremental Shuttle Walk Test, 3.0 points (95% CI, -3.7 to 9.9 points; P = .39) on the Pulmonary Embolism Quality of Life questionnaire, and 0.017 point (95% CI, -0.032 to 0.065 point; P = .50) on the EuroQol-5 Dimensions-3 Levels questionnaire. Of the 27 patients in the intervention group on sick leave at baseline, 24 (88.9%) reported fit-for-duty at the 6-month follow-up, and of 18 patients in the control group on sick leave, 17 (94.4%) reported fit-for-duty at the 6-month follow up. The between-group risk difference was not significant (5.5 points; P = .49). Conclusions and Relevance: An 8-week rehabilitation intervention with exercise added to nurse consultations did not show significantly better outcomes than nurse consultations alone. However, because of a ceiling effect on the primary outcome of physical capacity and an inclusion of patients with a low comorbidity burden and low PE disease severity, definitive conclusions could not be drawn. Initiating an exercise intervention shortly after pulmonary embolism was safe and without adverse events. Trial Registration: ClinicalTrials.gov Identifier: NCT02684721.

UR - http://www.scopus.com/inward/record.url?scp=85081076169&partnerID=8YFLogxK

U2 - 10.1001/jamanetworkopen.2020.0064

DO - 10.1001/jamanetworkopen.2020.0064

M3 - Journal article

C2 - 32108888

AN - SCOPUS:85081076169

VL - 3

JO - JAMA Network Open

JF - JAMA Network Open

SN - 2574-3805

IS - 2

M1 - e200064

ER -