(Cost) Effectiveness Study of Exercise Therapy in Patients With Peripheral Arterial Disease

Study Overview
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Brief Summary
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The purpose of this study is to determine if supervised exercise therapy in a physiotherapeutic setting, with or without therapy feedback, is more (cost-)effective than exercise therapy based on a 'go home and walk' advice without supervision, for patients with PAD stage II (Fontaine).

Detailed Description
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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.

Official Title
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Exercise Therapy in Patients With Peripheral Arterial Disease: the Costs and Effectiveness of Physiotherapeutic Supervision With or Without Therapy Feedback Versus a go Home and Walk Advice

Conditions
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Intermittent Claudication

Intervention / Treatment
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* Procedure: Exercise therapy
* Device: Accelerometer (PAM; Personal Activity Monitor)
* Procedure: Oral Exercise Therapy advise


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Exercise therapy|nan|
|Device: Accelerometer (PAM; Personal Activity Monitor)|nan|
|Procedure: Oral Exercise Therapy advise|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal walking distance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain-free walking distance |  |  | 
| blood pressure |  |  | 
| fasting glucose |  |  | 
| fasting cholesterol |  |  | 
| lipids profile |  |  | 
| body weight |  |  | 
| co-morbidity |  |  | 
| vascular interventions |  |  | 
| mortality |  |  | 
| medical and non-medical costs |  |  | 
| compliance |  |  | 
| quality of life |  |  | 
| impairment |  |  | 
| complaints |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD;, Intermittent claudication, Exercise therapy, Therapy feedback, Accelerometer, Physiotherapy, peripheral arterial disease according to Fontaine stage II)