To evaluate the long-term clinical effectiveness of patients with IC randomized for supervised exercise training orendovascular revascularization.
ID
Source
Brief title
Condition
- Lifestyle issues
- Vascular injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
maximum walking distance
Secondary outcome
preference based utilities (EQ-5Dand Rating Scale), health status QoL scores
(SF-36 and VascuQol), ankle-brachial index, maximum painless walking distance,
clinical success, risk factor score, number of events, patency rates
Background summary
Peripheral arterial disease (PAD) is a chronic atherosclerotic occlusive
disease of the lower
extremities. The first clinical symptom in patients with PAD is intermittent
claudication (IC) (i.e.,
Rutherford category 1, 2, or 3), which affects appoximately 275 000 people
older than 50 years in
the Netherlands alone. Despite developments in treatment for Intermittent
claudication, the standard treatment is not optimal. Results from studies
directly comparing long-term effects of supervised exercise training and
endovascular
revascularization are scarce. The CETAC study, a single centre RCT perfomed at
Ikazia hospital, compared
endovascular revascularization to supervised exercise training.
The CETAC study demonstrated that after both treatments, functional capacity
and quality-of-life scores
increased after 6- and 12-months follow-up in patients with IC. The improvement
in maximum walking distance
,however, was significantly better after supervised exercise compared to
endovascular revascularization
after 12 months follow-up. convincing evidence on long term effectiveness of
supervised exercise training compared to revascularization is
lacking.Therefore, the added value of the continuation of the prospective CETAC
study will be the long-term clinical effectiveness of supervised exercise
training compared to revascularization in patients with IC after a mean
follow up of 5 years.
Study objective
To evaluate the long-term clinical effectiveness of patients with IC randomized
for supervised exercise training or
endovascular revascularization.
Study design
Long-term follow up study of a RCT (CETAC study)
Study burden and risks
This study will be non-invasive for the participants and no risks are
associated with participation.
Montessoriweg 1
3083 AN Rotterdam
Nederland
Montessoriweg 1
3083 AN Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
As this study is a continuation of the CETAC study the inclusion criteria have
been described extensively in the CETAC study.
Exclusion criteria
As this study is a continuation of the CETAC study the exclusion criteria have
been described extensively in the CETAC study.
Design
Recruitment
Medical products/devices used
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 | NL27981.101.09 |