Identifying effective new interventions to prevent recurrence of venous leg ulcers in adults with chronic venous insufficiency.

2.50
Hdl Handle:
http://hdl.handle.net/10755/332764
Category:
Abstract
Type:
Research Study
Level of Evidence:
Randomized Controlled Trial
Research Approach:
Pilot/Exploratory Study
Title:
Identifying effective new interventions to prevent recurrence of venous leg ulcers in adults with chronic venous insufficiency.
Author(s):
Finlayson, Kathleen J.; Edwards, Helen E.; Gibb, Michelle
Lead Author STTI Affiliation:
Pi Delta
Author Details:
Kathleen Finlayson, PhD, RN, email: k.finlayson@qut.edu.au; Helen Edwards, PhD, RN, email: h.edwards@qut.edu.au; Michelle Gibb, MNursSc(NP), RN, email:michelle.gibb@qut.edu.au
Abstract:

Introduction
Leg ulcers are a significant cause of chronic ill-health for 1–3% of older adults.1 The average duration of these ulcers is 12 months2 and after healing up to 70% recur,2,3 with the highest recurrence rates occurring within the first 3 months after healing.3 The majority of leg ulcers are caused by venous pathophysiology following the failure of venous return mechanisms in the lower limbs (e.g. damaged valves, past deep vein thrombosis).4  The primary recommended preventive treatment is lifelong use of compression therapy. While this is effective,4 compression is associated with multiple difficulties with application and notoriously poor adherence.5 Neither the benefits of lower limb exercise or elevation as preventive strategies, nor the optimal duration or frequencies of these interventions are clear from current research. Previous work has found increased durations of lower limb exercise and leg elevation are significantly associated with a reduced risk of recurrence.3,6 This study aimed to test those findings with a more rigorous design to provide much needed information to promote health in this population.

Aim
This study aimed to determine the effectiveness of Venous Insufficiency Programs of Leg Exercise and/or Elevation (VIP Legs) on prevention of venous leg ulcer recurrence. 

Methods
All patients with a recently healed venous leg ulcer (within two weeks from recruitment), who were not cognitively impaired, and with an Ankle Brachial Pressure Index between 0.8–1.2 were invited to participate. Participants were randomised to either: the Control group, receiving routine compression therapy and recommendations as per evidence-based guidelines;  Intervention 1 group, receiving routine care as above plus the VIP Legs elevation intervention; or Intervention 2 group, receiving routine care as above plus the VIP Legs exercise and elevation intervention. Participants in the intervention groups were provided with a diary and documented instructions and diagrams, along with explanation, demonstration and supervised practice.

Data on demographics, health, venous history, clinical characteristics, treatments and recurrences were collected at recruitment, then 4, 8 and 12 weeks after healing. Participant questionnaires were used to obtain data on functional ability, quality of life, psychosocial factors and recurrences.  Descriptive analyses of all variables were conducted and Chi square tests to determine the effectiveness of the interventions on recurrence and identify differences between groups.  Mean times to recurrence for each group were compared using the Kaplan-Meier method and log-rank test.

Results
Nineteen participants were recruited for this pilot study. The average age was 65 years (SD 15.62), and 40% were female, 60% male.  Within the 12 weeks follow-up period, six participants had an ulcer recurrence: 40% (n=2) of the control group, 43% (n=3) of Intervention group 1, and 17% (n=1) of Intervention group 2 (ns). Although not significant in this small sample, the results suggest a downward trend in recurrence for the exercise and elevation group. Kaplan-Meier analysis found a trend towards increasing times before recurrence with the addition of interventions, with mean time fo recurrence in the control group of 9.2 weeks (95% CI 5.8–12.6); 9.7 weeks (95% CI 7.6–11.9) for Interention Group 1; and 10.7 weeks (95% CI 8.3–13.1) for Intervention Group 2 (ns).

Analysis of levels of physical activity and functional ability found low to moderate levels of activity across all groups. Although the control and Elevation only groups had only a slight increase over time, the Exercise and elevation group had substantial increases in their activity scores across time-points. Similar trends were found in quality of life scores, with low to moderate QOL scores reported on recruitment and a slightly increasing trend over time for the control and Elevation only groups, while the Exercise and elevation group had a 15 point increase in their median MCS scores across time-points. 

Conclusion
Although due to small group sizes this data must be viewed with caution, this project has shown that the addition of simple activities (exercise and/or elevation) to post-ulcer treatment can potentially result in reduced incidence of recurrence of venous leg ulcers. The outcomes of this research will be tested in larger studies and have the potential to result in improved health and quality of life for older adults with chronic venous insufficency.

References
1.  Briggs M & Closs SJ. The prevalence of leg ulceration. EWMA J 2003; 3:14-20.

2.  Walker N et al. Leg ulcers in New Zealand. New Zeal Med J 2002; 115:286-289.

3.  Finlayson K, Edwards H, Courtney M. Factors associated with recurrence of venous leg ulcers.  Int J Nurs Stud 2009; 46:1071-8.

4.  Nelson EA, Bell-Syer SEM, Cullum NA. Compression for preventing recurrence of venous ulcers. Cochrane Database of Systematic Reviews 2000; 4:CD002303.

5.  Graham ID et al. Leg ulcer care: nursing attitudes and knowledge. Canadian Nurse 2001; 97:19.

6.  Finlayson K, Edwards H, Courtney M. Relationships between preventive activities, psychosocial factors and recurrence of venous leg ulcers. J Adv Nurs 2011; 67(10): 2180-90.   

 

Keywords:
leg ulcer prevention and control; leg ulcer nursing
MeSH:
Leg Ulcer--prevention & control; Leg Ulcer--nursing; Venous Insufficiency
Repository Posting Date:
14-Oct-2014
Date of Publication:
14-Oct-2014
Sponsors:
Sigma Theta Tau International
Note:
Citation for a traditionally published manuscript with a similar topic by the same author: Finlayson, K., Edwards, H., & Courtney, M. (2011). Relationships between preventive activities, psychosocial factors and recurrence of venous leg ulcers: a prospective study. Journal of Advanced Nursing, 67(10), 2180-2190. doi:10.1111/j.1365-2648.2011.05653.x; The Sigma Theta Tau International grant application that funded this research, in whole or in part, was completed by the applicant and peer-reviewed prior to the award of the STTI grant. No further peer-review has taken place upon the completion of the STTI grant final report and its appearance in this repository.; This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.

Full metadata record

DC FieldValue Language
dc.language.isoenen
dc.type.categoryAbstracten
dc.typeResearch Studyen
dc.evidence.levelRandomized Controlled Trialen
dc.research.approachPilot/Exploratory Studyen
dc.titleIdentifying effective new interventions to prevent recurrence of venous leg ulcers in adults with chronic venous insufficiency.en
dc.contributor.authorFinlayson, Kathleen J.-
dc.contributor.authorEdwards, Helen E.-
dc.contributor.authorGibb, Michelle-
dc.contributor.departmentPi Deltaen
dc.author.detailsKathleen Finlayson, PhD, RN, email: k.finlayson@qut.edu.au; Helen Edwards, PhD, RN, email: h.edwards@qut.edu.au; Michelle Gibb, MNursSc(NP), RN, email:michelle.gibb@qut.edu.auen_GB
dc.identifier.urihttp://hdl.handle.net/10755/332764-
dc.description.abstract<table border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" width="819"> <p><strong>Introduction <br /></strong>Leg ulcers are a significant cause of chronic ill-health for 1–3% of older adults.<a title="Briggs, 2003 #225" href="/vhl/submit#_ENREF_1"><sup>1</sup></a> The average duration of these ulcers is 12 months<a title="Walker, 2002 #1854" href="/vhl/submit#_ENREF_2"><sup>2</sup></a> and after healing up to 70% recur,<a title="Walker, 2002 #1854" href="/vhl/submit#_ENREF_2"><sup>2</sup></a><sup>,</sup><a title="Finlayson, 2009 #551" href="/vhl/submit#_ENREF_3"><sup>3</sup></a> with the highest recurrence rates occurring within the first 3 months after healing.<a title="Finlayson, 2009 #551" href="/vhl/submit#_ENREF_3"><sup>3</sup></a> The majority of leg ulcers are caused by venous pathophysiology following the failure of venous return mechanisms in the lower limbs (e.g. damaged valves, past deep vein thrombosis).<a title="Nelson, 2000 #2246" href="/vhl/submit#_ENREF_4"><sup>4</sup></a>  The primary recommended preventive treatment is lifelong use of compression therapy. While this is effective,<a title="Nelson, 2000 #2246" href="/vhl/submit#_ENREF_4"><sup>4</sup></a> compression is associated with multiple difficulties with application and notoriously poor adherence.<a title="Graham, 2001 #694" href="/vhl/submit#_ENREF_5"><sup>5</sup></a> Neither the benefits of lower limb exercise or elevation as preventive strategies, nor the optimal duration or frequencies of these interventions are clear from current research. Previous work has found increased durations of lower limb exercise and leg elevation are significantly associated with a reduced risk of recurrence.<a title="Finlayson, 2009 #551" href="/vhl/submit#_ENREF_3"><sup>3</sup></a><sup>,</sup><a title="Finlayson, 2011 #3630" href="/vhl/submit#_ENREF_6"><sup>6</sup></a> This study aimed to test those findings with a more rigorous design to provide much needed information to promote health in this population.</p> <p><strong>Aim<br /></strong>This study aimed to determine the effectiveness of Venous Insufficiency Programs of Leg Exercise and/or Elevation (<em>VIP Legs</em>) on prevention of venous leg ulcer recurrence. </p> <p><strong>Methods<br /></strong>All patients with a recently healed venous leg ulcer (within two weeks from recruitment), who were not cognitively impaired, and with an Ankle Brachial Pressure Index between 0.8–1.2 were invited to participate. Participants were randomised to either: the Control group, receiving routine compression therapy and recommendations as per evidence-based guidelines;  Intervention 1 group, receiving routine care as above plus the <em>VIP Legs</em> elevation intervention; or Intervention 2 group, receiving routine care as above plus the <em>VIP Legs</em> exercise and elevation intervention. Participants in the intervention groups were provided with a diary and documented instructions and diagrams, along with explanation, demonstration and supervised practice.</p> <p>Data on demographics, health, venous history, clinical characteristics, treatments and recurrences were collected at recruitment, then 4, 8 and 12 weeks after healing. Participant questionnaires were used to obtain data on functional ability, quality of life, psychosocial factors and recurrences.  Descriptive analyses of all variables were conducted and Chi square tests to determine the effectiveness of the interventions on recurrence and identify differences between groups.  Mean times to recurrence for each group were compared using the Kaplan-Meier method and log-rank test.</p> <p><strong>Results<br /></strong>Nineteen participants were recruited for this pilot study. The average age was 65 years (SD 15.62), and 40% were female, 60% male.  Within the 12 weeks follow-up period, six participants had an ulcer recurrence: 40% (n=2) of the control group, 43% (n=3) of Intervention group 1, and 17% (n=1) of Intervention group 2 (ns). Although not significant in this small sample, the results suggest a downward trend in recurrence for the exercise and elevation group. Kaplan-Meier analysis found a trend towards increasing times before recurrence with the addition of interventions, with mean time fo recurrence in the control group of 9.2 weeks (95% CI 5.8–12.6); 9.7 weeks (95% CI 7.6–11.9) for Interention Group 1; and 10.7 weeks (95% CI 8.3–13.1) for Intervention Group 2 (ns).</p> </td> </tr> </tbody> </table> <p>Analysis of levels of physical activity and functional ability found low to moderate levels of activity across all groups. Although the control and <em>Elevation only </em>groups had only a slight increase over time, the <em>Exercise and elevation group</em> had substantial increases in their activity scores across time-points. Similar trends were found in quality of life scores, with low to moderate QOL scores reported on recruitment and a slightly increasing trend over time for the control and <em>Elevation only</em> groups, while the <em>Exercise and elevation</em> group had a 15 point increase in their median MCS scores across time-points. </p> <p><strong>Conclusion<br /></strong>Although due to small group sizes this data must be viewed with caution, this project has shown that the addition of simple activities (exercise and/or elevation) to post-ulcer treatment can potentially result in reduced incidence of recurrence of venous leg ulcers. The outcomes of this research will be tested in larger studies and have the potential to result in improved health and quality of life for older adults with chronic venous insufficency.<strong></strong></p> <p><strong>References<br /></strong>1.  Briggs M & Closs SJ. The prevalence of leg ulceration<em>.</em> EWMA J 2003; 3:14-20.</p> <p>2.  Walker N et al. Leg ulcers in New Zealand<em>.</em> New Zeal Med J 2002; 115:286-289.</p> <p>3.  Finlayson K, Edwards H, Courtney M. Factors associated with recurrence of venous leg ulcers.  Int J Nurs Stud 2009; 46:1071-8.</p> <p>4.  Nelson EA, Bell-Syer SEM, Cullum NA. Compression for preventing recurrence of venous ulcers<em>.</em> Cochrane Database of Systematic Reviews 2000; 4:CD002303.</p> <p>5.  Graham ID et al. Leg ulcer care: nursing attitudes and knowledge<em>.</em> Canadian Nurse 2001; 97:19.</p> <p>6.  Finlayson K, Edwards H, Courtney M. Relationships between preventive activities, psychosocial factors and recurrence of venous leg ulcers<em>.</em> J Adv Nurs 2011; 67(10): 2180-90.   </p> <p> </p>en_GB
dc.subjectleg ulcer prevention and controlen_GB
dc.subjectleg ulcer nursingen_GB
dc.subject.meshLeg Ulcer--prevention & controlen
dc.subject.meshLeg Ulcer--nursingen
dc.subject.meshVenous Insufficiencyen
dc.date.available2014-10-14T19:49:33Z-
dc.date.issued2014-10-14-
dc.date.accessioned2014-10-14T19:49:33Z-
dc.description.sponsorshipSigma Theta Tau Internationalen_GB
dc.description.noteCitation for a traditionally published manuscript with a similar topic by the same author: Finlayson, K., Edwards, H., & Courtney, M. (2011). Relationships between preventive activities, psychosocial factors and recurrence of venous leg ulcers: a prospective study. Journal of Advanced Nursing, 67(10), 2180-2190. doi:10.1111/j.1365-2648.2011.05653.xen
dc.description.noteThe Sigma Theta Tau International grant application that funded this research, in whole or in part, was completed by the applicant and peer-reviewed prior to the award of the STTI grant. No further peer-review has taken place upon the completion of the STTI grant final report and its appearance in this repository.en
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.-
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