Intermittent Claudication Clinical Trial
Official title:
The Effect of Encouragement on Six Minute Walk Test Performance in Patients With Intermittent Claudication
Peripheral artery disease (PAD) is characterised by a build up of fatty plaque in the arteries in the lower limbs, resulting in a reduction of blow flow to the muscles. Globally, it is estimated that 236 million people are living with PAD. A classic symptom of PAD is intermittent claudication (IC) which is characterised by muscle cramps in the lower limbs, typically brought on by exercise and relieved at rest. Exercise is recommended at first line treatment for IC. However to assess IC symptoms in response to an exercise study, maximal walking capacity (the furthest they can walk before it becomes too painful to walk) is typically the main measure. A patients walking capacity is assessed by a number of exercise testing protocols including the six-minute walk test (6MWT), where patients walk for six minutes with the aim to walk as far as they can in the time allotted. Patient encouragement has been shown to improve walking performance by as much as 30 meters in heart failure and respiratory disease populations. However the effect of encouragement on walking performance in people with IC is yet to be studied.
Status | Not yet recruiting |
Enrollment | 76 |
Est. completion date | January 1, 2024 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. >18 years old 2. Resting ankle brachial pressure index (ABPI) <0.9 or a reduction of = 20 mmHg following exercise testing (per site protocol) 3. Able to walk unaided 4. English speaking and able to follow exercise instructions 5. Able to provide informed consent Exclusion Criteria: 1. Those who have critical limb threatening ischaemia (rest pain and/or tissue loss) 2. Unable to provide consent 3. Those presenting with any significant comorbidities or contraindications to exercise testing or training in accordance to the American College of Sports Medicine 4. Uncontrolled or symptom limiting coronary heart or pulmonary disease |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Central Lancashire | Coventry University, University of Hull, University of Salford |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal walking distance (MWD) | Metres walked during the tests | 6 weeks | |
Secondary | Learning effect metres walked | To see if a learning effect exists between tests | 6 weeks |
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