Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
12 and 24 week change in rest times during a six-minute walk test |
Change in time spent resting during a six-minute walk test after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. |
Baseline to 12 weeks and 24 weeks |
|
| Other |
12 and 24 week change in pain cessation following a treadmill test |
Change in time to pain cessation following a treadmill test after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. |
Baseline to 12 weeks and 24 weeks |
|
| Other |
12 and 24 week changes in walking speed during a six-minute walk test |
Change in walking speed during a six-minute walk test after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. |
Baseline to 12 weeks and 24 weeks |
|
| Primary |
Intervention feasibility assessed via recruitment rate |
The investigators will record the number of eligible participants, as well as the number who enroll onto the study. |
Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion) |
|
| Primary |
Intervention feasibility assessed via attrition rate |
The investigators will record the number of protocol discontinuations and losses to follow-up. |
Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion) |
|
| Primary |
Intervention feasibility assessed via protocol adherence |
The investigators will examine discrepancies between intervention prescription and what is completed. |
Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion) |
|
| Primary |
Intervention acceptability via participant interviews |
One-to-one interviews will be held between an investigator and participant who has either completed the intervention, withdrawn or declined participation, to ask questions regarding the intervention protocol. |
Will be evaluated after the intervention period (either at 12 week or 24 week follow up) |
|
| Secondary |
12 and 24 week change in six-minute walk distance and pain-free walk distance |
Change in six-minute and pain-free walk distance after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. |
Baseline to 12 weeks and 24 weeks |
|
| Secondary |
12 and 24 week change in pain-free and maximal treadmill walk distance |
Change in pain-free and maximal treadmill walk distance after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. |
Baseline to 12 weeks and 24 weeks |
|
| Secondary |
12 and 24 weeks change in left and right hand grip strength (via hand held dynamometer) |
Change in left and right hand grip strength after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. |
Baseline to 12 weeks and 24 weeks |
|
| Secondary |
12 and 24 week change in physical activity measured by accelerometer data |
Change in physical activity behaviour at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group, using accelerometer data. |
Baseline to 12 weeks and 24 weeks |
|
| Secondary |
12 and 24 week change in SF-36 score |
Change in 36 Item Short Form survey scores at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. (Score ranges from 0-100, with higher scores associated with a better outcome). |
Baseline to 12 weeks and 24 weeks |
|
| Secondary |
12 and 24 week change in VascuQol questionnaire score |
Change in Vascular Quality of Life questionnaire scores at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. (Score ranges from 1-7, with higher scores associated with a better outcome). |
Baseline to 12 weeks and 24 weeks |
|
| Secondary |
12 and 24 week change in EQ-5D-5L questionnaire score |
Change in European Quality of Life Five Dimension questionnaire scores at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. (Scores range from 1-5, with lower scores associated with a better outcome). |
Baseline to 12 weeks and 24 weeks |
|
| Secondary |
12 and 24 week change in circulating markers of inflammation |
Investigators will compare blood sample measures of IL-6, TNF-a, CRP between participants randomised to the exercise group vs the usual care group at 12 and 24 weeks. |
Baseline to 12 weeks and 24 weeks |
|
| Secondary |
12 and 24 week change in circulating markers of vascular remodelling |
Investigators will compare blood sample measures of VEGF between participants randomised to the exercise group vs the usual care group at 12 and 24 weeks. |
Baseline to 12 weeks and 24 weeks |
|
