Quantitative Findings:

0 months

6 months

12 months

N *

Control

Intervention

Control

Intervention

Control

Intervention

p-value †

Vascular Quality of Life Questionnaire, means

303

14.7

14.6

15.6

17.3

16.0

17.1

0.02

HADS-A > 8, %

303

12%

19%

11%

17%

15%

21%

0.96

HADS-D > 8, %

303

9%

14%

6%

4%

2%

4%

0.76

General condition in the legs compared to baseline

303

-

-

9%

28%

22%

36%

Self-reported improvement in the legs among participants that did not improve on their maximum walking distance (<60 metres difference) between baseline and follow-up.

6 months

12 months

Control

(n=32)

Intervention

(n=19)

Chi^2-

p-value

Control

(n=26)

Intervention

(n=15)

Chi²-

p-value

Self-reported improvement in the legs compared to baseline

34%

63%

0.05

38%

60%

0.18

Quantitative Findings:

Vascular Quality of Life (VQ6) showed a significantly better score in the intervention group compared with the usual care group at 6 and 12 months (P=.020).

A higher value indicates better health status.

The anxiety and depression scale (HADS) showed no significant differences between the groups.

High prevalence of anxiety and depressive disorders among patients with PAD have previously been found. HADS score of 8-10 indicates the possible presence of a mood disorder, and > 11 indicates the probable presence of a mood disorder.

General self-reported condition in the legs compared to baseline showed that at 6 months, 9% in the control group and 28% in the intervention group felt that the condition was much better. At 12 months, 22% in the control group and 36% in the intervention group felt that the condition was much better. It is possible that participants in the intervention group who did not improve on their maximum walking distance still felt that they had improved their general condition in the legs. Therefore, it was evaluated if the proportion of participants with self-reported improvements in the legs at follow-up was larger in the intervention group compared to the control group. This analysis was only performed among participants without improvements in maximum walking distance, and therefore more participants in the control group than in the intervention group were included. The results showed that 34% of the participants in the control group experienced better condition in the legs at 6 months follow-up. In the intervention group, 63% experienced the same. The result was statistically significant (p=0.05). The same trend was seen regarding results on 12 months follow-up, but the result was not statistically significant (p=0.18).

Qualitative Findings:

The participants expressed improvement in well-being and feeling better mentally during the intervention. Knowledge about the disease helped to manage the pain: “…in my head, it helps a lot to know, now you are making… [collateral circulation] …now it is good…” (D); “…It occurred to me…when it hurts it is doing good…” (J). When the intervention ended, they felt it was difficult to exercise on their own, and they felt sad about missing their exercise community:

 “…something is missing afterwards. Walking alone is not the same …” (G); “I had a mental downturn when it stopped…” (F).

Mixed-Methods Inferences: Concordance

Qualitative and quantitative findings regarding VQ6, general condition in the legs and feeling better mentally confirmed each other as both indicated that participating in the intervention improved quality of life and general condition in the legs. Knowledge about the disease and feeling better mentally can explain the improvement in general condition in the legs, as some of the patients did not improve walking distance but an improved general condition in the legs.

Mixed-Methods inferences: Discordance

Qualitative and quantitative findings regarding HADS, general condition in the legs, and feeling better mentally were discordant as HADS showed no significant difference between the groups and qualitative findings indicate a difference.