To evaluate the cost-effectiveness, from the perspectives of the health care system and of society at large, of supervised exercise compared to endovascular revascularization plus supervised exercise as first-line treatment of IC.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: maximum walking distance; Secondary: preference based utilities (EQ-5D
and Rating Scale), health status QoL scores (SF-36 and VascuQol), ABI, maximum
painless walking distance, clinical success, therapeutic and total costs, CVD
risk factor score, number of events; all outcomes after 1-, 6-, and 12-months
follow-up.
Secondary outcome
NA
Background summary
Intermittent claudication (IC) is the first symptomatic manifestation of
peripheral arterial disease and affects 275 000 people older than 50 years in
the Netherlands alone. Despite developments in treatment for IC, the standard
treatment is not optimal. This project examines alternative treatments.
Study objective
To evaluate the cost-effectiveness, from the perspectives of the health care
system and of society at large, of supervised exercise compared to endovascular
revascularization plus supervised exercise as first-line treatment of IC.
Study design
Prospective multicenter Randomized Controlled Trial
Intervention
1. Supervised exercise at a physical therapy center;
2. Endovascular revascularization plus supervised exercise at a physical
therapy center
Study burden and risks
Endovascular revascularization and supervised exercise are standard treatments.
There is no risk.
Dr. Molewaterplein 40
3015 GD
NL
Dr. Molewaterplein 40
3015 GD
NL
Listed location countries
Age
Inclusion criteria
1. Rutherford category 1, 2, or 3
2. Maximum pain-free walking distance <350m
3. ABI <0.9 at rest or ABI decreasing by >0.15 after the treadmill test;
4. >=1 vascular stenoses of >50% diameter reduction at the iliac or femoro-popliteal level.
5. Informed consent
Exclusion criteria
1. Abdominal aortic aneurysm
2. Life-incapacitating cardiac disease (NYHA classification III and higher);
3. Multilevel disease (i.e., same-side stenoses at both the iliac and femoral levels, requiring multiple revascularization procedures)
4. Isolated tibial artery disease
5. Lesions deemed unsuitable for revascularization
6. Prior treatment for the same lesion (including exercise training)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30125.078.09 |