An interventional study of Exercise group in Peripheral Artery Disease and Intermittent Claudication, sponsored by Coventry University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-22.
Sponsored by Coventry University · Not applicable, Interventional, and Treatment
The purpose of the study is to assess the feasibility of undertaking a randomised controlled trial investigating the effectiveness of a 12-week home-based exercise programme for people with intermittent claudication.
30 participants with PAD will be randomised to one of two groups: either exercise or usual care. The 12 week exercise intervention will consist of a home-based circuit programme, including both resistance exercises and walking. This will be combined with promoting free-living walking throughout the rest of the week. Exercise will be regulated via the use of a wearable activity monitor. Biweekly phone calls will address compliance with the intervention. The primary outcomes are feasibility and acceptability, which will be determined after 12 weeks via recruitment and attrition rates, protocol adherence and with participant interviews. Secondary outcomes include changes in pain-free and maximal walking distances with both a graded treadmill test and six-minute walk test, hand grip strength, physical activity behaviour (measured with an accelerometer), quality of life (measured with the SF-36, VascuQol and E5-5D-5L questionnaires) after 12 and 24 weeks. Investigators will also assess changes in markers of inflammation, vascular remodeling, mitochondrial biogenesis and oxidative stress at 12 and 24 weeks. Other outcomes include changes in time spent resting during a six-minute walk test and time to pain cessation following a graded treadmill test at 12 and 24 weeks.
1,573 studies on the registry are indexed under Peripheral Arterial Disease; 284 are open to participants now.
This study's enrollment of 30 is below the median of 73 across 1,078 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Coventry University is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Home-based circuit and community walking exercise
Behavioral: Exercise group
Usual activity/healthcare
The exercise group will receive a 12-week home-based exercise programme, with a wearable activity watch to regulate physical activity behaviour. This group will also receive biweekly telephone calls from the investigator.
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.
Time frame: Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion)
Intervention feasibility assessed via attrition rate
The investigators will record the number of protocol discontinuations and losses to follow-up.
Time frame: Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion)
Intervention feasibility assessed via protocol adherence
The investigators will examine discrepancies between intervention prescription and what is completed.
Time frame: Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion)
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.
Time frame: Will be evaluated after the intervention period (either at 12 week or 24 week follow up)
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.
Time frame: Baseline to 12 weeks and 24 weeks
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.
Time frame: Baseline to 12 weeks and 24 weeks
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.
Time frame: Baseline to 12 weeks and 24 weeks
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.
Time frame: Baseline to 12 weeks and 24 weeks
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).
Time frame: Baseline to 12 weeks and 24 weeks
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).
Time frame: Baseline to 12 weeks and 24 weeks
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).
Time frame: Baseline to 12 weeks and 24 weeks
12 and 24 week change in circulating markers of inflammation
Investigators will compare blood sample measures of IL-6, TNF-α, CRP between participants randomised to the exercise group vs the usual care group at 12 and 24 weeks.
Time frame: Baseline to 12 weeks and 24 weeks
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.
Time frame: Baseline to 12 weeks and 24 weeks
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.
Time frame: Baseline to 12 weeks and 24 weeks
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.
Time frame: Baseline to 12 weeks and 24 weeks
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.
Time frame: Baseline to 12 weeks and 24 weeks
Plan to share: No
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Coventry University