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Study protocol
Esther Tinoco Volpe
Universidade Federal do Rio Grande do Norte
Corresponding Author
ORCiD: https://orcid.org/0000-0003-2805-5751
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Chronic venous insufficiency (CVI) causes pathophysiological changes in lower limb muscles, particularly calf muscles, and limits ankle range of motion (ROM). These changes reduce functional activities and decreases quality of life (QOL). Although several studies have shown benefits of exercise (strengthening the calf muscles to improve calf muscle pumping and QOL) in patients with CVI, few studies are randomized controlled trials. This has led to a weak indication of exercise for the treatment of patients with CVI. The aim of this study is to analyze the effects of a supervised exercise program to improve calf muscle endurance as well as QOL in patients with CVI. Methods: This is an evaluator-blind, randomized clinical trial with an 8-week duration and a follow-up evaluation at week 16. A pilot study with subjects with CVI diagnosis will be performed to calculate sample size. The participants will be randomly allocated (1:1) into a treatment or control group (usual care/no intervention). The treatment intervention consists of a bi-weekly supervised exercise program of the lower limbs that will include aerobic training, strengthening, and cardiovascular exercises. The participants from both groups will participate in a health education lecture. Primary outcomes are changes in calf muscle endurance and QOL score. Secondary outcomes are changes in exercise capacity, ankle ROM, electrical muscle activity and cardiac output. Discussion: Patients with CVI may have an impaired calf muscle pump and decreased exercise capacity. A randomized controlled trial evaluating a supervised exercise program will provide much needed information on the management of CVI to promote health and independence. Trial registration: This study was registered on the Brazilian Clinical Trials Database (REBEC) (RBR-57xtk7). The results will be disseminated at scientific events, presentations, and publications in peer reviewed journals. Keywords: Exercise, Resistance Training, Exercise Therapy, Venous Insufficiency, Randomized Controlled Trial, Rehabilitation
Keywords
Exercise, Resistance Training, Exercise Therapy, Venous Insufficiency, Randomized Controlled Trial, Rehabilitation
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CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Editorial decision: Accept
On 10 Apr, 2020
Review #1 received
Received 16 Mar, 2020
Reviewers invited
Invitations sent on 01 Mar, 2020
Reviewer #1 agreed
On 01 Mar, 2020
Editor assigned
On 27 Feb, 2020
Submission checks complete
On 26 Feb, 2020
Version 3
Posted 27 Nov, 2019
No comments provided
Editorial decision: Major revision
On 09 Dec, 2019
Review #1 received
Received 03 Dec, 2019
Review #2 received
Received 03 Dec, 2019
Reviewer #2 agreed
On 29 Nov, 2019
Reviewer #1 agreed
On 25 Nov, 2019
Editor assigned
On 25 Nov, 2019
Reviewers invited
Invitations sent on 25 Nov, 2019
Submission checks complete
On 24 Nov, 2019
No comments provided
Editorial decision: Major revision
On 02 Sep, 2019
Review #3 received
Received 13 Aug, 2019
Review #2 received
Received 13 Aug, 2019
Reviewer #2 agreed
On 12 Aug, 2019
Reviewer #3 agreed
On 12 Aug, 2019
Review #1 received
Received 12 Aug, 2019
Editor assigned
On 09 Aug, 2019
Reviewers invited
Invitations sent on 09 Aug, 2019
Reviewer #1 agreed
On 09 Aug, 2019
Submission checks complete
On 08 Aug, 2019
No comments provided
Editorial decision: Major revision
On 23 May, 2019
Review #3 received
Received 19 May, 2019
Review #1 received
Received 13 May, 2019
Review #2 received
Received 08 May, 2019
Reviewer #3 agreed
On 05 May, 2019
Reviewer #2 agreed
On 03 May, 2019
Reviewer #1 agreed
On 02 May, 2019
Reviewers invited
Invitations sent on 10 Mar, 2019
Editor assigned
On 19 Feb, 2019
Submission checks complete
On 22 Jan, 2019
First submitted
On 20 Jan, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
General Medicine
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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
Esther Tinoco Volpe
Universidade Federal do Rio Grande do Norte
Corresponding Author
ORCiD: https://orcid.org/0000-0003-2805-5751
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.
No community comments so far
Editorial decision: Accept
On 10 Apr, 2020
Review #1 received
Received 16 Mar, 2020
Reviewers invited
Invitations sent on 01 Mar, 2020
Reviewer #1 agreed
On 01 Mar, 2020
Editor assigned
On 27 Feb, 2020
Submission checks complete
On 26 Feb, 2020
Version 3
Posted 27 Nov, 2019
No comments provided
Editorial decision: Major revision
On 09 Dec, 2019
Review #1 received
Received 03 Dec, 2019
Review #2 received
Received 03 Dec, 2019
Reviewer #2 agreed
On 29 Nov, 2019
Reviewer #1 agreed
On 25 Nov, 2019
Editor assigned
On 25 Nov, 2019
Reviewers invited
Invitations sent on 25 Nov, 2019
Submission checks complete
On 24 Nov, 2019
No comments provided
Editorial decision: Major revision
On 02 Sep, 2019
Review #3 received
Received 13 Aug, 2019
Review #2 received
Received 13 Aug, 2019
Reviewer #2 agreed
On 12 Aug, 2019
Reviewer #3 agreed
On 12 Aug, 2019
Review #1 received
Received 12 Aug, 2019
Editor assigned
On 09 Aug, 2019
Reviewers invited
Invitations sent on 09 Aug, 2019
Reviewer #1 agreed
On 09 Aug, 2019
Submission checks complete
On 08 Aug, 2019
No comments provided
Editorial decision: Major revision
On 23 May, 2019
Review #3 received
Received 19 May, 2019
Review #1 received
Received 13 May, 2019
Review #2 received
Received 08 May, 2019
Reviewer #3 agreed
On 05 May, 2019
Reviewer #2 agreed
On 03 May, 2019
Reviewer #1 agreed
On 02 May, 2019
Reviewers invited
Invitations sent on 10 Mar, 2019
Editor assigned
On 19 Feb, 2019
Submission checks complete
On 22 Jan, 2019
First submitted
On 20 Jan, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
General Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background: Chronic venous insufficiency (CVI) causes pathophysiological changes in lower limb muscles, particularly calf muscles, and limits ankle range of motion (ROM). These changes reduce functional activities and decreases quality of life (QOL). Although several studies have shown benefits of exercise (strengthening the calf muscles to improve calf muscle pumping and QOL) in patients with CVI, few studies are randomized controlled trials. This has led to a weak indication of exercise for the treatment of patients with CVI. The aim of this study is to analyze the effects of a supervised exercise program to improve calf muscle endurance as well as QOL in patients with CVI. Methods: This is an evaluator-blind, randomized clinical trial with an 8-week duration and a follow-up evaluation at week 16. A pilot study with subjects with CVI diagnosis will be performed to calculate sample size. The participants will be randomly allocated (1:1) into a treatment or control group (usual care/no intervention). The treatment intervention consists of a bi-weekly supervised exercise program of the lower limbs that will include aerobic training, strengthening, and cardiovascular exercises. The participants from both groups will participate in a health education lecture. Primary outcomes are changes in calf muscle endurance and QOL score. Secondary outcomes are changes in exercise capacity, ankle ROM, electrical muscle activity and cardiac output. Discussion: Patients with CVI may have an impaired calf muscle pump and decreased exercise capacity. A randomized controlled trial evaluating a supervised exercise program will provide much needed information on the management of CVI to promote health and independence. Trial registration: This study was registered on the Brazilian Clinical Trials Database (REBEC) (RBR-57xtk7). The results will be disseminated at scientific events, presentations, and publications in peer reviewed journals. Keywords: Exercise, Resistance Training, Exercise Therapy, Venous Insufficiency, Randomized Controlled Trial, Rehabilitation
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
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