Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00279994
Acronym
EXITPAD
Enrollment
300
Registered
2006-01-20
Start date
2005-12-31
Completion date
2009-05-31
Last updated
2008-05-09

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

Conditions

Intermittent Claudication

Keywords

Intermittent claudication, Exercise therapy, Therapy feedback, Accelerometer, Physiotherapy, PAD;, peripheral arterial disease according to Fontaine stage II)

Brief summary

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

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.

Interventions

PROCEDUREExercise therapy
DEVICEAccelerometer (PAM; Personal Activity Monitor)
PROCEDUREOral Exercise Therapy advise

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development
CollaboratorOTHER
Maastricht University
CollaboratorOTHER
Atrium Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
maximal walking distance

Secondary

MeasureTime frame
blood pressure
fasting glucose
fasting cholesterol
lipids profile
body weight
co-morbidity
pain-free walking distance
mortality
medical and non-medical costs
compliance
quality of life
impairment
complaints
vascular interventions

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026