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

ISRCTN	ISRCTN73659272
DOI	https://doi.org/10.1186/ISRCTN73659272
Secondary identifying numbers	N/A

Submission date: 06/07/2009
Registration date: 11/09/2009
Last edited: 11/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Marie Guidon
Scientific

Royal College of Surgeons in Ireland
123 St Stephen's Green
Dublin
2
Ireland

Study information

Study design	Single centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Exercise and intermittent claudication: health outcomes and cost effectiveness in a single centre randomised controlled trial
Study objectives	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(s)	Beaumont Hospital Ethics Committee approved in November 2005
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/12/2006
Completion date	01/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	46
Key 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
Key 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
Date of first enrolment	01/12/2006
Date of final enrolment	01/06/2010

Locations

Countries of recruitment

Ireland

Study participating centre

Royal College of Surgeons in Ireland

Dublin
2
Ireland

Sponsor information

Royal College of Surgeons in Ireland (Ireland)
Research organisation

c/o Marie Guidon
123 St Stephens Green
Dublin
2
Ireland

Website	http://www.rcsi.ie/
"ROR"	https://ror.org/01hxy9878

Funders

Funder type

Research organisation

Royal College of Surgeons in Ireland (Ireland) - Research Committee

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan