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Study protocol
Stacey Haukeland-Parker
Sykehuset Østfold
Corresponding Author
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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-centre 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 hour) 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: NCT03405480, Clinical Trials (registered prospectively.
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).
Keywords
Pulmonary embolism, rehabilitation, dyspnea, exercise capacity, quality of life, randomized controlled trial
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CURRENT STATUS: Published
View the published article at Trials.
Version 3
Posted 08 Dec, 2020
No community comments so far
Editorial decision: Accept
On 29 Nov, 2020
Editor assigned
On 28 Nov, 2020
Submission checks complete
On 28 Nov, 2020
No comments provided
Reviewer #2 agreed
On 11 Nov, 2020
Reviewer #1 agreed
On 08 Nov, 2020
Review #1 received
Received 08 Nov, 2020
Reviewers invited
Invitations sent on 05 Nov, 2020
Editor assigned
On 03 Nov, 2020
Submission checks complete
On 03 Nov, 2020
No comments provided
Review #2 received
Received 13 Oct, 2020
Editorial decision: Major revision
On 13 Oct, 2020
Reviewer #2 agreed
On 29 Sep, 2020
Review #1 received
Received 21 Sep, 2020
Reviewer #1 agreed
On 09 Sep, 2020
Reviewers invited
Invitations sent on 19 Aug, 2020
Editor assigned
On 12 Aug, 2020
Submission checks complete
On 13 Jun, 2020
First submitted
On 30 Apr, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Stacey Haukeland-Parker
Sykehuset Østfold
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
Version 3
Posted 08 Dec, 2020
No community comments so far
Editorial decision: Accept
On 29 Nov, 2020
Editor assigned
On 28 Nov, 2020
Submission checks complete
On 28 Nov, 2020
No comments provided
Reviewer #2 agreed
On 11 Nov, 2020
Reviewer #1 agreed
On 08 Nov, 2020
Review #1 received
Received 08 Nov, 2020
Reviewers invited
Invitations sent on 05 Nov, 2020
Editor assigned
On 03 Nov, 2020
Submission checks complete
On 03 Nov, 2020
No comments provided
Review #2 received
Received 13 Oct, 2020
Editorial decision: Major revision
On 13 Oct, 2020
Reviewer #2 agreed
On 29 Sep, 2020
Review #1 received
Received 21 Sep, 2020
Reviewer #1 agreed
On 09 Sep, 2020
Reviewers invited
Invitations sent on 19 Aug, 2020
Editor assigned
On 12 Aug, 2020
Submission checks complete
On 13 Jun, 2020
First submitted
On 30 Apr, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
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-centre 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 hour) 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: NCT03405480, Clinical Trials (registered prospectively.
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).
Figure 1
Figure 1
Figure 2
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
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