Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Exercise and intermittent claudication: health outcomes and cost effectiveness in a single centre randomised controlled trial
Acronym
Study hypothesis
Peripheral arterial disease (PAD) is a manifestation of generalised atherosclerotic disease in which the arterial lumen becomes progressively narrowed by atherosclerotic plaques. This gradual narrowing of the lumen results in reduced blood flow to the tissues causing pain on exercise, relieved by rest (intermittent claudication). PAD is a marker for significant cardiovascular and cerebrovascular events (e.g., myocardial infarction [MI], stroke). Despite its prevalence and associated cardiovascular risk factors, patients with PAD are treated less intensively than patients with coronary artery disease. Several studies have demonstrated that exercise programmes result in significant improvements in walking distances but the long-term benefits and effects on subsequent cardiovascular morbidity and mortality are unknown. The aim of this study is:
1. To assess the long-term effects on risk factor modification
2. To assess the long-term effects on quality of life
3. To assess the long-term effects on fatal and non-fatal events
4. To compare the cost effectiveness over time between the current management strategy and exercise intervention
Ethics approval
Beaumont Hospital Ethics Committee approved in November 2005
Study design
Single centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Intermittent claudication
Intervention
Intervention Group:
Participants participate in a twice-weekly supervised exercise programme for 12 weeks. The total duration of the programme is one hour, including warm-up and cool down periods.
Participants undertake a 10 minute warm-up consisting of gentle walking, stepping and stretching exercises (upper limb, lower limb and trunk). Participants then exercise for 30 - 40 minutes using a range of exercise equipment: treadmill, stepper, elliptical trainer, recumbent cycle ergometer and upper/lower limb cycle ergometer. Participants are encouraged to exercise at an intensity of 70 - 80% heart rate maximum or 70 - 80% of their exercise stress test maximum. On the treadmill participants are encouraged to continue exercising until they are unable to continue due to leg pain (generally a maximum of 10 minutes). Participants are then permitted to rest until the pain subsided and then encouraged to recommence exercising. The exercise level is set at an intensity that produced moderate claudication pain within 5 minutes. Exercise is progressed by increasing resistance and/or time.
Control Group:
Usual care.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Recorded at baseline, 12 weeks and 1 year:
1. Risk factors:
1.1. Diastolic and systolic blood pressure
1.2. Height
1.3. Weight
1.4. Waist circumference
1.5. Ankle/brachial index (ABI) at rest and exercise
1.6. Laboratory test results: fasting blood glucose, triglycerides, cholesterol, plasma fibrinogen, high-sensitivity C-reactive protein (hs-CRP), glycosylated haemoglobin (HbA1C)
2. Generic health status: 36-item short form health survey questionnaire (SF36)
3. Disease-specific health status: Intermittent Claudication Questionnaire (ICQ)
4. Functional capacity: Walking Impairment Questionnaire (WIQ)
5. Physical activity: peripheral Arterial Disease Physical Activity Recall Questionnaire (PAD-PAR)
Secondary outcome measures
Recorded at baseline, 12 weeks and 1 year:
1. Health status valuation - EQ5D
2. Morbidity and mortality data from hospital paper and computer records
Overall trial start date
01/12/2006
Overall trial end date
01/06/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Fontaine Stage II: intermittent claudication diagnosed by history of leg pain on exercise relieved by rest, classified by presence/absence of pulse/s, site of pain, ankle/brachial index (ABI) less than 0.9 at rest and/or decrease in ankle pressure by 15 mmHg or more after standard treadmill test (standard incline and constant speed)
2. Stable disease x 3 months
3. Residing within the geographical catchment area of the hospital
4. Aged 48 - 83 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
46
Participant exclusion criteria
1. Fontaine Stage I (ambulation not limited by claudication)
2. Fontaine Stage III (rest pain)
3. Fontaine Stage IV (focal necrosis)
4. Co-existing clinical condition, which precluded participation in exercise programme including:
4.1. Unstable cardiorespiratory disease
4.2. Neurological/orthopaedic limitation to exercise
4.3. Poorly controlled hypertension
4.4. Active major medical problem including but not limited to cancer, renal/liver disease
4.5. Dementia
4.6. Poorly controlled diabetes mellitus
4.7. Abdominal aortic aneurysm
4.8. Myocardial infarction within the previous 6 months
5. Participants with acute onset or within the first months of onset of claudication (due to fluctuation in symptoms)
6. Revascularisation procedure/surgery within previous 6 months
Recruitment start date
01/12/2006
Recruitment end date
01/06/2010
Locations
Countries of recruitment
Ireland
Trial participating centre
Royal College of Surgeons in Ireland
Dublin
2
Ireland
Sponsor information
Organisation
Royal College of Surgeons in Ireland (Ireland)
Sponsor details
c/o Marie Guidon
123 St Stephens Green
Dublin
2
Ireland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Royal College of Surgeons in Ireland (Ireland) - Research Committee
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary