(Cost) Effectiveness Study of Exercise Therapy in Patients With Peripheral Arterial Disease
Keywords
Abstract
Description
Exercise therapy (ET) is considered to be the main conservative treatment for patients with intermittent claudication (IC) and is documented to be effective, especially when supervised. However, wide scale introduction of supervised ET in the Netherlands would lead to a substantial increase of health care costs compared to current practice, while the cost-effectiveness of supervised ET is uncertain. ET follows a pattern of short walking periods that induce discomfort of moderate intensity and short rest periods. The psychological, metabolic, and mechanical alterations that occur during exercise stimulate an adaptive response that ultimately reduces the symptoms. The optimal therapy regimen depends to a large extent on home-based exercises, which require discipline from the patient. Currently, the main prescription for ET for patients with IC in the Netherlands is a single 'go home and walk' advice, without supervision or follow-up. There is no evidence to support the effectiveness of this advice and compliance is low. In studies comparing the 'go home and walk' advice to supervised ET, a large advantage for supervised ET was present. The inadequate use of the main conservative treatment for peripheral arterial disease (PAD) contributes to a gradual progression of this condition, a decrease in quality of life, and an increasing number of vascular interventions. Furthermore, with adequate ET, hypertension, hypercholesterolemia, overweight, and diabetes, if present, is better regulated.
Dates
| Last Verified: | 04/30/2008 |
| First Submitted: | 01/18/2006 |
| Estimated Enrollment Submitted: | 01/18/2006 |
| First Posted: | 01/19/2006 |
| Last Update Submitted: | 05/05/2008 |
| Last Update Posted: | 05/08/2008 |
| Actual Study Start Date: | 11/30/2005 |
| Estimated Study Completion Date: | 04/30/2009 |
Condition or disease
Intervention/treatment
Procedure: Exercise therapy
Device: Accelerometer (PAM; Personal Activity Monitor)
Procedure: Oral Exercise Therapy advise
Phase
Eligibility Criteria
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - PAD stage II - Ankle-brachial index below 0.9 - Maximal walking distance of 500 meters or less Exclusion Criteria: - prior ET - previous peripheral vascular interventions - no insurance for physiotherapy - insufficient command of the Dutch language - serious cardiopulmonary limitations (NYHA-3-4) - previous amputation - psychiatric instability - other serious co-morbidity prohibiting physical training |
Outcome
Primary Outcome Measures
1. maximal walking distance [undefined]
Secondary Outcome Measures
1. pain-free walking distance [undefined]
2. blood pressure [undefined]
3. fasting glucose [undefined]
4. fasting cholesterol [undefined]
5. lipids profile [undefined]
6. body weight [undefined]
7. co-morbidity [undefined]
8. vascular interventions [undefined]
9. mortality [undefined]
10. medical and non-medical costs [undefined]
11. compliance [undefined]
12. quality of life [undefined]
13. impairment [undefined]
14. complaints [undefined]
