Effects of exercise on health and quality of life in peripheral arterial disease

Exercise and intermittent claudication: health outcomes and cost effectiveness in a single centre randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN73659272

Enrollment

Registered

2009-09-11

Start date

2006-12-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent claudication Circulatory System Other peripheral vascular diseases

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
Recorded at baseline, 12 weeks and 1 year: 1. Health status valuation - EQ5D 2. Morbidity and mortality data from hospital paper and computer records	—

Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026