Electronic Supplementary MaterialStudy types: Clinical article, clinical trial, comparative study,...

Sports Medicine

Combined Lower Limb Revascularisation and Supervised Exercise Training for Patients with Peripheral Arterial

Disease: A Systematic Review of Randomised Controlled Trials

Annelise L. Menêses, Raphael M. Ritti-Dias, Belinda Parmenter, Jonathan Golledge, Christopher D. Askew

Corresponding Author: Associate Professor Christopher D. Askew. School of Health and Sport Sciences, University of

the Sunshine Coast, Australia. E-mail: [email protected]

Electronic Supplementary Material

1

mailto:[email protected]

Electronic Supplementary Material Table S1. Search strategy for CENTRAL in The Cochrane Library

#1 MeSH descriptor: [Peripheral Arterial Disease] explode all trees

#2 MeSH descriptor: [Intermittent Claudication] explode all trees

#3 peripheral near/3 disease*:ti,ab,kw

#4 "claudication":ti,ab,kw

#5 #1 OR #2 OR #3 OR #4

#6 MeSH descriptor: [Vascular Surgical Procedures] explode all trees

#7 MeSH descriptor: [Stents] explode all trees

#8 "stent":ti,ab,kw

#9 "endarterectomy":ti,ab,kw

#10 "angioplasty":ti,ab,kw

#11 catheter*:ti,ab,kw

#12 "grafting":ti,ab,kw

#13 "bypass":ti,ab,kw

#14 surg*:ti,ab,kw

#15 vasculari*:ti,ab,kw

#16 "endovascular":ti,ab,kw

#17 revasculari*:ti,ab,kw

#18 "balloon":ti,ab,kw

#19 "endoluminal":ti,ab,kw

#20 (#6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR

#18 OR #19)

#21 MeSH descriptor: [Exercise] explode all trees

#22 MeSH descriptor: [Exercise Therapy] explode all trees

#23 exercis*:ti,ab,kw (Word variations have been searched)

#24 "isometric":ti,ab,kw (Word variations have been searched)

#25 "aerobic":ti,ab,kw (Word variations have been searched)

#26 train*:ti,ab,kw (Word variations have been searched)

#27 "treadmill":ti,ab,kw (Word variations have been searched)

#28 "resistance":ti,ab,kw (Word variations have been searched)

#29 weight next lift*:ti,ab,kw (Word variations have been searched)

#30 "jogging":ti,ab,kw (Word variations have been searched)

#31 walk*:ti,ab,kw (Word variations have been searched)

#32 "cycling":ti,ab,kw (Word variations have been searched)

#33 "running":ti,ab,kw (Word variations have been searched)

#34 "endurance":ti,ab,kw (Word variations have been searched)

#35 ergomet*:ti,ab,kw (Word variations have been searched)

#36 muscular next exercise*:ti,ab,kw (Word variations have been searched)

#37 "physical training":ti,ab,kw (Word variations have been searched)

2

#38 physical next activit*:ti,ab,kw (Word variations have been searched)

#39 physical next therap*:ti,ab,kw (Word variations have been searched)

#40 (#21 OR #22 OR #23 OR #24 OR #25 OR #26 OR #27 OR #28 OR #29 OR #30 OR #31 OR #32

OR #33 OR #34 OR #35 OR #36 OR #37 OR #38 OR #39)

#41 (#5 AND #20 AND #40)

Filters Trials

3

Electronic Supplementary Material Table S2. Search strategy for PubMed

#1 peripheral arterial disease[MH]

#2 intermittent claudication[MH]

#3 peripheral arterial disease*[TIAB]

#4 peripheral artery disease*[TIAB]

#5 peripheral vascular disease*[TIAB]

#6 claudication[TIAB]

#7 #1 OR #2 OR #3 OR #4 OR #5 OR #6

#8 vascular surgical procedures[MH]

#9 stents[MH]

#10 stent*[TIAB]

#11 endarterectomy[TIAB]

#12 angioplast*[TIAB]

#13 catheter*[TIAB]

#14 grafting[TIAB]

#15 bypass[TIAB]

#16 surg*[TIAB]

#17 vasculari*[TIAB]

#18 endovascular[TIAB]

#19 revasculari*[TIAB]

#20 balloon[TIAB]

#21 endoluminal[TIAB]

#22 #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR

#20 OR #21

#23 exercise[MH]

#24 exercise therapy[MH]

#25 exercis*[TIAB]

#26 isometric[TIAB]

#27 aerobic[TIAB]

#28 train*[TIAB]

#29 treadmill[TIAB]

#30 resist*[TIAB]

#31 weight lifting[TIAB]

#32 jogging[TIAB]

#33 walking[TIAB]

#34 cycling[TIAB]

#35 running[TIAB]

#36 endurance[TIAB]

#37 ergomet*[TIAB]

4

#38 muscular exercise*[TIAB]

#39 physical training[TIAB]

#40 physical activit*[TIAB]

#41 physical therap*[TIAB]

#42 #23 OR #24 OR #25 OR #26 OR #27 OR #28 OR #29 OR #30 OR #31 OR #32 OR #33 OR #34

OR #35 OR #36 OR #37 OR #38 OR #39 OR #40 OR #41 OR #42

#43 #7 AND #22 AND #42

Limits NOT case reports[PT]

NOT clinical conference[PT]

NOT comment[PT]

NOT guideline[PT]

NOT letter[PT]

NOT meta-analysis[PT]

NOT review[PT]

5

Electronic Supplementary Material Table S3. Search strategy for EMBASE

#1 ''peripheral occlusive artery disease'/exp

#2 ''intermittent claudication'/exp

#3 (peripheral next/3 disease*):ab,ti

#4 claudication:ab,ti

#5 #1 OR #2 OR #3 OR #4 OR #5

#6 'vascular surgery'/exp

#7 'leg revascularization'/exp

#8 ''vascular stent'/exp

#9 'nonsurgical invasive therapy'/exp

#10 stent*:ab,ti

#11 endarterectomy:ab,ti

#12 angioplast*:ab,ti

#13 catheter*:ab,ti

#14 grafting:ab,ti

#15 bypass:ab,ti

#16 surg*:ab,ti

#17 vascular*:ab,ti

#18 endovascular:ab,ti

#19 revasculari*:ab,ti

#20 balloon:ab,ti

#21 endoluminal:ab,ti


#18 OR #19 OR #20 OR #21

#23 'exercise'/exp

#24 'training'/exp

#25 'physical activity'/exp

#26 'endurance'/exp

#27 exercis*:ab,ti

#28 isometric:ab,ti

#29 aerobic:ab,ti

#30 train*:ab,ti

#31 treadmill:ab,ti

#32 resist*:ab,ti

#33 "weight lifting":ab,ti

#34 jogging:ab,ti

#35 walking:ab,ti

#36 cycling:ab,ti

#37 running:ab,ti

6

#38 endurance:ab,ti

#39 ergomet*:ab,ti

#40 "muscular exercise":ab,ti

#41 "physical training":ab,ti

#42 (physical next/1 activit*):ab,ti

#43 (physical next/1 therap*):ab,ti


OR #35 OR #36 OR #37 OR #38 OR #38 OR #40 OR #41 OR #42 OR #43

#45 #5 AND #22 AND #44

Filters Publication types: Article, article in press

Study types: Clinical article, clinical trial, comparative study, controlled clinical trial, controlled

study, double blind procedure, human, intermethod comparison, major clinical study, multicenter

study, clinical article, prospective study, randomized controlled trial

Diseases: Claudication, intermittent claudication, limb ischemia, peripheral occlusive artery

disease, peripheral vascular disease

7

Electronic Supplementary Material Table S4. Search strategy for CINAHL

#1 peripheral W3 (disease OR diseases)

#2 claudication

#3 #1 OR #2

#4 stent*

#5 endarterectomy

#6 angioplast*

#7 catheter*

#8 grafting

#9 bypass

#10 surg*

#11 vascular*

#12 endovascular

#13 revasculari*

#14 balloon

#15 endoluminal


#17 exercis*

#18 isometric

#19 aerobic

#20 train*

#21 treadmill

#22 resist*

#23 "weight lifting"

#24 jogging

#25 walking

#26 cycling

#27 running

#28 endurance

#29 ergomet*

#30 muscular exercise*

#31 "physical training"

#32 physical activit*

#33 physical therap*


OR #29 OR #30 OR #31 OR #32 OR #33

#35 #3 AND #16 AND #34

Filters Source type: Academic journals

Peer reviewed

8

Electronic Supplementary Material Table S5. Search strategy for SPORTDiscus

#1 peripheral W3 (disease OR diseases)

#2 claudication

#3 #1 OR #2

#4 stent*

#5 endarterectomy

#6 angioplast*

#7 catheter*

#8 grafting

#9 bypass

#10 surg*

#11 vascular*

#12 endovascular

#13 revasculari*

#14 balloon

#15 endoluminal


#17 exercis*

#18 isometric

#19 aerobic

#20 train*

#21 treadmill

#22 resist*


#24 jogging

#25 walking

#26 cycling

#27 running

#28 endurance

#29 ergomet*






OR #29 OR #30 OR #31 OR #32 OR #33

#35 #3 AND #16 AND #34

Filters Source type: Academic journals

10

Electronic Supplementary Material Table S6. Search strategy for Scopus

#1 peripheral PRE/2 disease*

#2 claudication

#3 #1 OR #2

#4 stent*

#5 endarterectomy

#6 angioplast*

#7 catheter*

#8 grafting

#9 bypass

#10 surg*

#11 vascular*

#12 endovascular

#13 revasculari*

#14 balloon

#15 endoluminal


#17 exercis*

#18 isometric

#19 aerobic

#20 train*

#21 treadmill

#22 resist*


#24 jogging

#25 walking

#26 cycling

#27 running

#28 endurance

#29 ergomet*






OR #29 OR #30 OR #31 OR #32 OR #33

#35 #3 AND #16 AND #34

Filters AND NOT: TITLE(review)

AND NOT: TITLE("case report*)

11

Document type: Articles

Document type: Articles in press

Subject area: Medicine

Subject area: Nursing

Subject area: Health professions

Source type: Journals

Keywords: Human

Keywords: Humans

12

Electronic Supplementary Material Table S7. Search strategy for Web of Science

#1 TS=(peripheral NEAR/2 disease*)

#2 TS=(claudication)

#3 TI=(peripheral NEAR/2 disease*)

#4 TI=(claudication)

#5 #1 OR #2 OR #3 OR #4

#6 TS=(angioplast*)

#7 TS=(surg*)

#8 TS=(revasculari*)

#9 TI=(stent*)

#10 TI=(endarterectomy)

#11 TI=(angioplast*)

#12 TI=(catheter*)

#13 TI=(grafting)

#14 TI=(bypass)

#15 TI=(surg*)

#16 TI=(vascular*)

#17 TI=(endovascular)

#18 TI=(revasculari*)

#19 TI=(balloon)

#20 TI=(endoluminal)


#18 OR #19 OR #20

#22 TS=(exercis*)

#23 TS=(physical NEAR/1 activit*)

#24 TS=(physical NEAR/1 therap*)

#25 TI=(exercis*)

#26 TI=(isometric)

#27 TI=(aerobic)

#28 TI=(train*)

#29 TI=(treadmill)

#30 TI=(resist*)

#31 TI=("weight lifting")

#32 TI=(jogging)

#33 TI=(walking)

#34 TI=(cycling)

#35 TI=(running)

#36 TI=(endurance)

#37 TI=(ergomet*)

13

#38 TI=("muscular exercise")

#39 TI=("physical training")

#40 TI=(physical NEAR/1 activit*)

#41 TI=(physical NEAR/1 therap*)


OR #34 OR #35 OR #36 OR #37 OR #38 OR #39 OR #40 OR #41

#43 #5 AND #21 AND #42

Filters Document types: Article

Indexes=SCI-EXPANDED, SSCI

SCI-EXPANDED – Science Citation Index Expanded (1900 to present); SSCI – Social Sciences Citation Index

(1900 to present)

14

Electronic Supplementary Material Table S8 Characteristics of excluded studies

Study Reasons for exclusion

Franco et al. 1980 [1] Non-randomised trial. Results are presented for all groups together, not separately

Lundgren et al. 1989 [2] Duplicate data (early results) from Lundgren et al. 1989 [3]

Mazari et al. 2010 [4] Duplicate data (early results) from Mazari et al. 2012 [5]

Nordanstig et al. 2011 [6] This trial compares revascularisation with non-invasive treatment (standard medical care, and standard advice regarding smoking cessation, exercise)

Fakhry et al. 2013 [7] Patients were randomised to undergo revascularisation alone or SET alone

Jakubseviciene et al. 2014 [8]Both groups of comparison underwent the same combined therapy and one group underwent an additional period of unsupervised training (R+SET versus

R+SET+nonSET). A control group is required to make the trial eligible for inclusion in the review

Bo et al. 2014 [9] Duplicate data (early results) from Bo et al. 2013 [10]

Matsuo et al. 2015 [11] Non-randomised trial. Patients were allocated to SET alone or post-operative SET based on the post-operative change in physical activity levels

SET supervised exercise therapy, R+SET Revascularisation plus supervised exercise therapy, non-SET unsupervised exercise therapy

15

Electronic Supplementary Material Table S9 Pain free walking distance (m): revascularisation alone/exercise training alone (control) versus combined therapy of revascularisation plus exercise

training

Study

Time

point

(weeks)

Revascularisation or

exercise training

pre


exercise training

post

Combined

pre

Combined

post

Between group

MD [95% CI]

Between group

ES [95% CI]

ES p-

value

Reported

between

group p-

value

Revascularisation versus combined therapy of revascularisation plus exercise training

Constant load treadmill walking test

Lundgren et al. 1989 [3] 12 85 ± 30 Δ 320 ± 357 70 ± 35 Δ 489 ± 380 169 [-58 to 396] 0.45 [-0.16 to 1.05] 0.14 NR

Mazari et al. 2012 [5] 12 31 ± 32 76 ± 66 44 ± 23 126 ± 245 38 [26 to 49] 1.31 [0.88 to 1.75] <0.01 NR

Graded treadmill walking test

Kruidenier et al. 2011 [12] 24 282 ± 293 547 ± 264 186 ± 116 842 ± 478 391 [276 to 506] 1.73 [1.14 to 2.33] <0.01 <0.01

Bo et al. 2013 [10] 12 137 ± 128 251 ± 405 164 ± 120 480 ± 563 203 [128 to 279] 1.62 [0.94 to 2.30] <0.01 NR

Exercise training versus combined therapy of revascularisation plus exercise training


Lundgren et al. 1989 [3] 12 67 ± 35 Δ 120 ± 215 70 ± 35 Δ 489 ± 380 369 [178 to 560] 1.17 [0.52 to 1.81] <0.01 NR

Greenhalgh et al. 2008 [13]a 24 63 ± 30 23% Pt PFW≥200m 71 ± 41 32% Pt PFW≥200m UTC UTC UTC 0.05

Greenhalgh et al. 2008 [13]b 24 64 ± 20 0% Pt PFW≥200m 49 ± 38 60% Pt PFW≥200m UTC UTC UTC 0.01



Fakhry et al. 2015 [14] 48 135 ± 88 Δ 712 ± 640 117 ± 83 Δ 1120 ± 675 408 [230 to 586] 0.61 [0.33 to 0.89] <0.01 <0.01

Values are mean ± standard deviation unless otherwise stated. a,bGreenhalgh et al. 2008 [13] was divided into two trials as patients were stratified according to the anatomical site of

revascularisation (femoropopliteal or aortoiliac) prior to randomisation. Pt patients, PFWD pain free walking distance, MD mean difference, CI confidence interval, ES effect size, Δ change from

baseline, NR not reported, UTC unable to calculate. Between-group ES = (Δtreatment- Δcontrol)/pooled baseline SD; Significance was determined from p-value reported or confidence interval

excluding 0 if no p-value was reported

16

Electronic Supplementary Material Table S10 Maximal walking distance (m): revascularisation alone/exercise training alone (control) versus combined therapy of revascularisation plus exercise

training

Study

Time

point

(weeks)


exercise training

pre


exercise training

post

Combined

pre

Combined

post

Between group

MD [95% CI]

Between group

ES [95% CI]

ES p-

value

Reported

between

group p-

value




Badger et al. 2007 [15] 6 Not assessed Δ 4% ± 3% Not assessed Δ 175% ± 118% UTC UTC UTC <0.01



Kruidenier et al. 2011 [12] 24 343 ± 248 685 ± 314 293 ± 190 956 ± 490 321 [207 to 435] 1.44 [0.87 to 2.00] <0.01 <0.01

Bo et al. 2013 [10] 12 285 ± 204 446 ± 252 399 ± 270 658 ± 392 98 [-46 to 242] 0.40 [-0.18 to 0.98] 0.18 NR




Greenhalgh et al. 2008 [13]a 24 126 ± 62 NR 133 ± 77 NR UTC 1.06 [0.80 to 1.41] ≤0.05 0.69

Greenhalgh et al. 2008 [13]b 24 126 ± 53 NR 114 ± 87 NR UTC 1.75 [1.02 to 3.02] 0.04 0.04



Fakhry et al. 2015 [14] 48 285 ± 165 Δ 955 ± 663 264 ± 145 Δ 1237 ± 703 282 [97 to 467] 0.41 [0.13 to 0.68] <0.01 <0.01


revascularisation (femoropopliteal or aortoiliac) prior to randomisation. Greenhalgh et al. 2008 [13]a and Greenhalgh et al. 2008 [13]b did not report post-intervention data (standard deviation) for

each comparison group but did provide between-group effect size data. MD mean difference, CI confidence interval, ES effect size, Δ change from baseline, NR not reported, UTC unable to

calculate. Between-group ES = (Δtreatment- Δcontrol)/pooled baseline SD; Significance was determined from p-value reported or confidence interval excluding 0 if no p-value was reported

17

Electronic Supplementary Material Table S11 Six-minute walking distance (m): revascularisation alone (control) versus combined therapy of revascularisation plus

exercise training

Study

Time

point

(weeks)

Revascularisation

pre

Revascularisation

post

Combined

pre

Combined

post

Between group

MD [95% CI]

Between group

ES [95% CI]

ES p-

value

Reported

between

group p-

value

Bo et al. 2013 [10] 12 407 ± 99 480 ± 77 412 ± 94 492 ± 82 7 [-48 to 63] 0.08 [-0.49 to 0.64] 0.79 NR

Values are mean ± standard deviation unless otherwise stated. MD mean difference, CI confidence interval, ES effect size, NR not reported. Between-group ES =

(Δtreatment- Δcontrol)/pooled baseline SD; Significance was determined from p-value reported or confidence interval excluding 0 if no p-value was reported

18

Electronic Supplementary Material Table S12 Resting ankle-brachial index: revascularisation alone/exercise training alone (control) versus combined therapy of revascularisation plus exercise

training

Study

Time

point

(weeks)


exercise training

pre


exercise training

post

Combined

pre

Combined

post

Between group

MD [95% CI]

Between group

ES [95% CI]

ES p-

value

Reported

between

group p-

value


Lundgren et al. 1989 [3] 12 0.55 ± 0.15 Δ 0.35 ± 0.14 0.59 ± 0.10 Δ 0.30 ± 0.14 -0.05 [-0.14 to 0.04] -0.35 [-0.95 to 0.25] 0.25 >0.05

Badger et al. 2007 [15] 6 Not assessed Δ 0.08 ± 0.08 Not assessed Δ 0.23 ± 0.11 UTC UTC UTC 0.02

Kruidenier et al. 2011 [12] 24 0.71 ± 0.18 0.93 ± 0.18 0.69 ± 0.21 0.88 ± 0.19 -0.03 [-0.13 to 0.07] -0.15 [-0.65 to 0.34] 0.55 0.75

Mazari et al. 2012 [5] 12 0.71 ± 0.25 0.92 ± 0.36 0.64 ± 0.24 0.98 ± 0.19 0.13 [0.03 to 0.23] 0.53 [0.12 to 0.93] 0.01 NR

Bo et al. 2013 [10] 12 0.63 ± 0.30 0.82 ± 0.20 0.64 ± 0.30 0.90 ± 0.15 0.07 [-0.12 to 0.26] 0.23 [-0.37 to 0.83] 0.45 NR


Lundgren et al. 1989 [3] 12 0.59 ± 0.15 Δ 0.04 ± 0.14 0.59 ± 0.10 Δ 0.30 ± 0.14 0.26 [0.17 to 0.35] 1.82 [1.11 to 2.53] <0.01 ≤0.01

Greenhalgh et al. 2008 [13]a 24 0.69 ± 0.12 NR 0.66 ± 0.14 NR UTC UTC UTC NR

Greenhalgh et al. 2008 [13]b 24 0.66 ± 0.11 NR 0.68 ± 0.19 NR UTC UTC UTC NR

Mazari et al. 2012 [5] 12 0.72 ± 0.22 0.75 ± 0.19 0.64 ± 0.24 0.98 ± 0.19 0.31 [0.22 to 0.40] 1.32 [0.87 to 1.77] <0.01 NR

Fakhry et al. 2015 [14] 48 0.68 ± 0.16 Δ 0.03 ± 0.20 0.71 ± 0.18 Δ 0.16 ± 0.20 0.13 [0.08 to 0.18] 0.64 [0.36 to 0.91] <0.01 <0.01


revascularisation (femoropopliteal or aortoiliac) prior to randomisation. Greenhalgh et al 2008 [13]a and Greenhalgh et al. 2008 [13]b reported only 2-year follow-up data, which revealed a

significant effect in favour of combined therapy over supervised exercise training in both trials (Greenhalgh et al. 2008 [13]a ES 0.11, 95% CI 0.03 to 0.20; p=0.01; Greenhalgh et al. 2008 [13]b ES

0.14, 95% CI 0.03 to 0.26; p=0.02). MD mean difference, CI confidence interval, ES effect size, Δ change from baseline, NR not reported, UTC unable to calculate. Between-group ES =


19

Electronic Supplementary Material Table S13 Resting calf arterial blood flow (ml.100ml-1.min-1): revascularisation alone/exercise training alone (control) versus combined therapy of

revascularisation plus exercise training

Study

Time

point

(weeks)


exercise training

pre


exercise training

post

Combined

pre

Combined

post

Between group

MD [95% CI]

Between group

ES [95% CI]

ES p-

value

Reported

between

group p-

value


Lundgren et al. 1989 [3] 12 14.80 ± 7.50 Δ 7.60 ± 6.87 15.20 ± 8.00 Δ 9.90 ± 11.26 2.30 [-3.48 to 8.08] 0.24 [-0.36 to 0.84] 0.43 >0.05

Exercise training versus combined Therapy of Revascularisation plus Exercise Training

Lundgren et al. 1989 [3] 12 16.70 ± 8.50 Δ 3.00 ± 5.49 15.20 ± 8.00 Δ 9.90 ± 11.26 6.90 [1.40 to 12.40] 0.76 [0.14 to 1.38] 0.02 ≤0.02

Values are mean ± standard deviation unless otherwise stated. MD mean difference, CI confidence interval, ES effect size, Δ change from baseline. Between-group ES = (Δtreatment-

Δcontrol)/pooled baseline SD; Significance was determined from p-value reported or confidence interval excluding 0 if no p-value was reported

20

Electronic Supplementary Material Table S14 Quality of life (SF-36 Physical Health): revascularisation alone/exercise training alone (control) versus combined therapy of revascularisation

plus exercise training

Study

Time

point

(weeks)


exercise training

pre


exercise training

post

Combined

pre

Combined

post

Between group

MD [95% CI]

Between group

ES [95% CI]

ES p-

value

Reported

between

group p-

value


Badger et al. 2007 [15] 6 Not assessed Δ 36 ± 4 Not assessed Δ 40 ± 4 UTC UTC UTC 0.11

Kruidenier et al. 2011 [12] 24 31 ± 9 44 ± 8 31 ± 8 42 ± 10 -2 [-6 to 3] -0.20 [-0.70 to 0.30] 0.43 0.90


Bo et al. 2013 [10] 24 48 ± 9 47 ± 13 52 ± 9 53 ± 9 3 [-2 to 8] 0.36 [-0.23 to 0.94] 0.22 NR


Greenhalgh et al. 2008 [13]a 24 40 ± 7 NR 39 ± 9 NR UTC UTC UTC NR

Greenhalgh et al. 2008 [13]b 24 38 ± 8 NR 38 ± 9 NR UTC UTC UTC NR



revascularisation (femoropopliteal or aortoiliac) prior to randomisation. Greenhalgh et al. 2008 [13]a and Greenhalgh et al. 2008 [13]b reported only 2-year follow-up data, which revealed that

combined therapy had no added effect over supervised exercise training in the femoropopliteal trial (Greenhalgh et al. 2008 [13]a ES -0.4, 95% CI -4.2 to 3.4; p=0.82), and a significant effect in

favour of combined therapy in the aortoiliac trial (Greenhalgh et al 2008 [13]b ES 7.8, 95% CI 1.5 to 14.1; p=0.02). MD mean difference, CI confidence interval, ES effect size, Δ change from

baseline, NR not reported, UTC unable to calculate. Between-group ES = (Δtreatment- Δcontrol)/pooled baseline SD; Significance was determined from p-value reported or confidence interval

excluding 0 if no p-value was reported

21

Electronic Supplementary Material Table S15 Quality of life (SF-36 Mental Health): revascularisation alone/exercise training alone (control) versus combined therapy of revascularisation

plus exercise training

Study

Time

point

(weeks)


exercise training

pre


exercise training

post

Combined

pre

Combined

post

Between group

MD [95% CI]

Between group

ES [95% CI]

ES p-

value

Reported

between

group p-

value


Badger et al. 2007 [15] 6 Not assessed Δ 34 ± 3 Not assessed Δ 41 ± 6 UTC UTC UTC 0.08

Kruidenier et al. 2011 [12] 24 54 ± 12 49 ± 12 54 ± 12 54 ± 9 5 [-1 to 11] 0.41 [-0.10 to 0.91] 0.11 0.04

Mazari et al. 2012 [5] 12 67 ± 180 100 ± 120 67 ± 94 100 ± 57 0 [-59 to 59] 0.00 [-0.41 to 0.41] 1.00 NR

Bo et al. 2013 [10] 24 52 ± 7 50 ± 9 50 ± 10 51 ± 12 3 [-3 to 8] 0.29 [-0.29 to 0.88] 0.32 NR


Greenhalgh et al. 2008 [13]a 24 48 ± 13 NR 50 ± 11 NR UTC UTC UTC NR

Greenhalgh et al. 2008 [13]b 24 44 ± 11 NR 43 ± 12 NR UTC UTC UTC NR

Mazari et al. 2012 [5] 12 33 ± 112 100 ± 88 67 ± 94 100 ± 57 -33 [-75 to 8] -0.31 [-0.71 to 0.08] 0.12 NR


revascularisation (femoropopliteal or aortoiliac) prior to randomisation. Greenhalgh et al. 2008 [13]a and Greenhalgh et al.2008 [13]b provided 2-year follow-up data, which revealed that

combined therapy had no added effect over supervised exercise training in both trials (Greenhalgh et al. 2008 [13]a ES 2.4, 95% CI -1.7 to 6.5; p=0.25; Greenhalgh et al. 2008 [13]b ES 4.9,

95% CI -1.3 to 11.1; p=0.12). MD mean difference, CI confidence interval, ES effect size, Δ change from baseline, NR not reported, UTC unable to calculate. Between-group ES =


22

References

1. Franco A, Legrand E, Guidicelli H, et al. Results of the physiotherapy of arterial disease at the stage of intermittent claudication by programmed efforts training (author's transl). J Mal Vasc. 1980;5:185-9.

2. Lundgren F, Dahllof AG, Schersten T, et al. Muscle enzyme adaptation in patients with peripheral arterial insufficiency: spontaneous adaptation, effect of different treatments and consequences on walking performance. Clin Sci (Lond). 1989;77:485-93.

3. Lundgren F, Dahllof AG, Lundholm K, et al. Intermittent claudication-surgical reconstruction or physical training? A prospective randomized trial of treatment efficiency. Ann Surg. 1989;209:346-55.

4. Mazari FA, Gulati S, Rahman MN, et al. Early outcomes from a randomized, controlled trial of supervised exercise, angioplasty, and combined therapy in intermittent claudication. Ann Vasc Surg. 2010;24:69-79.

5. Mazari FA, Khan JA, Carradice D, et al. Randomized clinical trial of percutaneous transluminal angioplasty, supervised exercise and combined treatment for intermittent claudication due to femoropopliteal arterial disease. Br J Surg. 2012;99:39-48.

6. Nordanstig J, Gelin J, Hensäter M, et al. Walking performance and health-related quality of life after surgical or endovascular invasive versus non-invasive treatment for intermittent claudication - a prospective randomised trial. Eur J Vasc Endovasc Surg. 2011;42:220-7.

7. Fakhry F, Rouwet EV, Den Hoed PT, et al. Long-term clinical effectiveness of supervised exercise therapy versus endovascular revascularization for intermittent claudication from a randomized clinical trial. Br J Surg. 2013;100:1164-71.

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