| 1. |
- Gelin, Johan, 1948, et al.
(författare)
-
Treatment efficacy of intermittent claudication by surgical intervention, supervised physical exercise training compared to no treatment in unselected randomised patients I: one year results of functional and physiological improvements.
- 2001
-
Ingår i: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - : Elsevier BV. - 1078-5884. ; 22:2, s. 107-13
-
Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: to compare the effect of surgery, exercise and simple observation on maximum exercise power in claudicants. Design: prospective, randomised study. METHODS: a total of 264 unselected claudicants were randomised to supervised exercise training, invasive treatment (open surgical or endovascular procedures) or observation. One year treatment outcomes were analysed on an intention to-treat basis. RESULTS: invasively treated patients showed a significant improvement in maximum walking power, stopping distance, post-ischaemic blood flow and big toe pressure at one year. Patients randomised to physical exercise training or to the control group did not improve in any outcome measure. CONCLUSION: invasive treatment increased walking capacity, leg blood pressure and flow. Supervised physical exercise training offered no therapeutic advantage compared to untreated controls.
|
|
| 2. |
|
|
| 3. |
- Taft, Charles, 1950, et al.
(författare)
-
Predictors of treatment outcome in intermittent claudication.
- 2004
-
Ingår i: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - 1078-5884. ; 27:1, s. 24-32
-
Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To derive formulae to predict the likely 12-month health-related quality of life outcome following different treatments for intermittent claudication (IC). DESIGN: A prospective, randomized, controlled study. MATERIALS: One hundred and seventy-one unselected patients with stable IC were sequentially randomized to invasive therapy, supervised physical training or observation. Hierarchical analysis was used to identify significant predictors of outcome. RESULTS: The strongest outcome predictors were baseline values of the respective outcome variables in all groups. No more than two significant secondary predictors were identified for each outcome variable and no outcome variable was a predictor of any other outcome variable. Resulting prediction equations achieved between 61 and 90% concordance with improvement (75% considered adequate), with best prediction for invasive therapy and poorest for observation. Suggested cutpoints for the various endpoints in the three groups had sensitivities ranging between 65 and 100% and false positive rates between 5 and 50%. CONCLUSIONS: The derived equations adequately predicted improvement on the various outcome variables in invasive therapy and supervised physical training, and may serve as aids in selecting patients likely to benefit most from a particular treatment strategy. The uniqueness of the outcome variables underscores the importance of implementing a comprehensive set of endpoints relevant to the impacts of the condition.
|
|
| 4. |
- Taft, Charles, 1950, et al.
(författare)
-
Treatment efficacy of intermittent claudication by invasive therapy, supervised physical exercise training compared to no treatment in unselected randomised patients II: one-year results of health-related quality of life.
- 2001
-
Ingår i: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. - : Elsevier BV. - 1078-5884. ; 22:2, s. 114-23
-
Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: to compare the effectiveness of invasive therapy, supervised physical training and no treatment in terms of health-related quality of life (HRQL) in patients with intermittent claudication (IC). DESIGN: a prospective, randomised, controlled study. MATERIALS: a total of 253 unselected patients with stable IC were sequentially randomised into 3 balanced treatment groups. At 1 year follow-up data from a battery of generic and disease specific HRQL questionnaires, and global indices of quality of life and physical condition were available in 171 patients. RESULTS: compared with a non-diseased reference group, claudicants were substantially limited in daily physical functioning, but little affected regarding emotional, cognitive and social functioning, or well-being. Invasive therapy yielded significantly greater improvements in some aspects of physical functioning and walk-related symptoms than training. Training was not superior to invasive therapy on any HRQL dimension and superior to no treatment on only one dimension. Treatment effects, however, were generally small-to-moderate and levels of physical dysfunction in all groups remained higher than reference values. CONCLUSIONS: invasive therapy is more effective than supervised training in alleviating illness-specific symptoms and improving certain aspects of physical functioning - the primary HRQL domains impacted on by IC and the principal goals of its treatment. However, since treatment effect sizes were at most moderate and given that untreated claudicants reported at most small deterioration in HRQL, the level of evidence supporting invasive therapy is modest.
|
|
| 5. |
|
|
| 6. |
- Nordanstig, Joakim, et al.
(författare)
-
Improved Quality of Life After 1 Year With an Invasive Versus a Noninvasive Treatment Strategy in Claudicants One-Year Results of the Invasive Revascularization or Not in Intermittent Claudication (IRONIC) Trial
- 2014
-
Ingår i: Circulation. - : Ovid Technologies (Wolters Kluwer Health). - 0009-7322 .- 1524-4539. ; 130:12, s. 939-947
-
Tidskriftsartikel (refereegranskat)abstract
- Background-The quality of evidence for invasive revascularization in intermittent claudication is low or very low. This prospective, randomized, controlled study tested the hypothesis that an invasive treatment strategy versus continued noninvasive treatment improves health-related quality of life after 1 year in unselected patients with intermittent claudication. Methods and Results-After clinical and duplex ultrasound assessment, unselected patients with intermittent claudication requesting treatment for claudication were randomly assigned to invasive (n=79) or noninvasive (n=79) treatment groups. Primary end point was health-related quality of life after 1 year, assessed with Medical Outcomes Study Short Form 36 version 1 and Vascular Quality of Life Questionnaire, and secondary end points included walking distances on a graded treadmill. The Medical Outcomes Study Short Form 36 version 1 physical component summary (P<0.001) and 2 Medical Outcomes Study Short Form 36 version 1 physical subscales improved significantly more in the invasive versus the noninvasive treatment group. Overall, Vascular Quality of Life Questionnaire score (P<0.01) and 3 of 5 domain scores improved significantly more in the invasive versus the noninvasive treatment group. Intermittent claudication distance improved significantly in the invasive (+124 m) versus the noninvasive (+50 m) group (P=0.003), whereas the change in maximum walking distance was not significantly different between groups. Conclusions-An invasive treatment strategy improves health-related quality of life and intermittent claudication distance after 1 year in patients with stable lifestyle-limiting claudication receiving current medical management. Long-term follow-up data and health-economic assessments are warranted to further establish the role for revascularization in intermittent claudication.
|
|
| 7. |
|
|
| 8. |
- Nordanstig, Joakim, et al.
(författare)
-
Two-year results from a randomized clinical trial of revascularization in patients with intermittent claudication
- 2016
-
Ingår i: British Journal of Surgery. - : Oxford University Press (OUP). - 0007-1323 .- 1365-2168. ; 103:10, s. 1290-1299
-
Tidskriftsartikel (refereegranskat)abstract
- BackgroundIntermittent claudication is associated with significant impairment of health-related quality of life. The use of revascularization techniques to improve health-related quality of life remains controversial. MethodsPatients with intermittent claudication due to iliac or femoropopliteal peripheral artery disease were enrolled in the IRONIC trial. They were randomized to either best medical therapy (BMT), including a structured, non-supervised exercise programme, or revascularization with either endovascular or open techniques in addition to BMT. The primary outcome was health-related quality of life at 2years assessed using the Short Form 36 (SF-36((R))) questionnaire. Secondary outcomes included VascuQoL questionnaire results, treadmill walking distances and achievement of patient-specified treatment goals. ResultsBoth randomized groups had improved health-related quality of life and treadmill walking distance at 2-year follow-up. Overall SF-36((R)) physical component summary score, three SF-36((R)) physical domain scores, overall VascuQoL score, and three of five VascuQoL domain scores showed significantly greater improvement in the group that also received invasive treatment. Intermittent claudication distance on a graded treadmill improved more in the revascularization + BMT group (117 versus 55m; P=0003) whereas maximum walking distance and 6-min walk test distance were similar. Some 44 per cent of patients in the revascularization + BMT group reported they had fully achieved their treatment goal versus 10 per cent in the BMT group. ConclusionA revascularization strategy with unsupervised exercise improved health-related quality of life and intermittent claudication distance more than standard BMT and an unsupervised exercise programme in patients with lifestyle-limiting claudication. Registration number: NCT01219842 (http://www.clinicaltrials.gov).
|
|
| 9. |
|
|
| 10. |
- Nordanstig, Joakim, et al.
(författare)
-
Walking Performance and Health-related Quality of Life after Surgical or Endovascular Invasive versus Non-invasive Treatment for Intermittent Claudication - A Prospective Randomised Trial
- 2011
-
Ingår i: European Journal of Vascular and Endovascular Surgery. - : Elsevier BV. - 1078-5884. ; 42, s. 220-227
-
Tidskriftsartikel (refereegranskat)abstract
- Objectives: Despite limited scientific evidence for the effectiveness of invasive treatment for intermittent claudication (IC), revascularisation procedures for IC are increasingly often performed in Sweden. This randomised controlled trial compares the outcome after 2 years of primary invasive (INV) versus primary non-invasive (NON) treatment strategies in unselected IC patients. Materials/Methods: Based on arterial duplex and clinical examination, IC patients were randomised to INV (endovascular and/or surgical, n=100) or NON (n=101). NON patients could request invasive treatment if they deteriorated during follow-up. Primary outcome was maximal walking performance (MWP) on graded treadmill test at 2 years and secondary outcomes included health-related quality of life (HRQL), assessed with Short Form (36) Health Survey (SF-36). Results: MWP was not significantly (p=0.104) improved in the INV versus the NON group. Two SF-36 physical subscales, Bodily Pain (p<0.01) and Role Physical (p<0.05) improved significantly more in the INV versus the NON group. There were 7% crossovers against the study protocol in the INV group. Conclusions: Although invasive treatment did not show any significant advantage regarding MWP, the HRQL improvements associated with invasive treatment tentatively suggest secondary benefits of this regimen. On the other hand, a primary non-invasive treatment strategy seems to be accepted by most IC patients.
|
|
