The objective of this study is to investigate what the value is of SET after a radiological or surgical intervention for peripheral arterial disease in the aorto-iliacal, femoro-popliteal and crural segments in comparison with a control group.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the absolute claudication distance in meters. This is
the distance at which a patient can not walk any further, and is determined by
a standard treadmill protocol.
Secondary outcome
Additional outcomes are initial claudication distance, quality of life,
fontaine stadium, ankle brachial index, vascular risk factors,
re-interventions, number of attended sessions, patency and mortality.
Background summary
Treatment of peripheral arterial disease consists of vascular risk factor
management and, dependent on the severity of the disease, exercise therapy, and
either radiological or surgical intervention. After invasive treatment, many
patients keep complaints, or complaints return, despite the fact that the
treated segment is still patent.
Supervised exercise therapy (SET) has been proved to be an effective treatment
for patients with intermittent claudication, with a significant increase in
maximal walking distance. Further, exercise therapy contributes to an
improvement in quality of life, a delay in disease progression and an
improvement of the vascular risk profile.
Research on SET after an invasive intervention is rare. In one study, the
effect of SET after surgical treatment on walking distance was determined. The
initial claudication distance increased significantly in the exercise group,
compared with surgical treatment alone.
In June 2004, the Network for Exercise Therapy Parkstad (NETP) was implemented
in Heerlen and its environs. The physiotherapists of this network provide
community based SET according to the protocol of the Royal Dutch Society of
Physiotherapy. The web based database, which is a part of the NETP, was
retrospectively searched for patients who started SET within 2 months after a
radiological or surgical intervention. Seventeen patients fulfilled these
criteria, and after 1, 3, 6 and 12 months, there was a significant increase in
both initial claudication distance (ICD) and absolute claudication distance
(ACD).
The expectation is that SET, immediately offered after an invasive intervention
for peripheral arterial disease, influences walking distance and quality of
life. Further, a positive influence on vascular risk factors and the frequency
of re-interventions is expected.
Study objective
The objective of this study is to investigate what the value is of SET after a
radiological or surgical intervention for peripheral arterial disease in the
aorto-iliacal, femoro-popliteal and crural segments in comparison with a
control group.
Study design
When, on medical grounds, a decision has been made to perform an invasive
intervention, patients are randomly assigned to regular care or regular care
without additional SET. Stratification takes place, according to localisation
(aorto-iliacal, femoro-popliteal, crural).
Patients assigned to SET receive exercise therapy from a trained
physiotherapist of their own choice, according to the guideline of the Royal
Dutch Society of Physiotherapists. Follow up of the ICD and ACD takes place at
baseline, after invasive intervention, and after 1 month, 3 months, 6 months
and 12 months. Patients in the control group receive the same follow up from a
trained physiotherapist.
Every patient receives the regular follow up in the hospital according to the
CBO-consensus at baseline, and after 3, 6 and 12 months.
Intervention
For 12 months the intervention group receives exercise therapy with supervision
from a trained physiotherapist, according to the protocol of the Royal Dutch
Society of Physiotherapists.
Study burden and risks
Patients who participate in this study receive regular patient care. Patients
benefit from the fact that vascular risk management is well organised.
The questionnaires are an extra burden for the patients, although the
questionnaires are short. The intervention group follows 12 months of SET. The
potential cardiac risk is screened and in case of doubt a cardiologist is asked
for his professional opinion. At start, SET is time consuming, but the number
of sessions is gradually decreasing. Benefits of exercise therapy are better
condition, potential weight loss, increasing strength and a more positive risk
factor profile.
Henri Dunantstraat 5
6401 CX Heerlen
NL
Henri Dunantstraat 5
6401 CX Heerlen
NL
Listed location countries
Age
Inclusion criteria
Patients with peripheral arterial disease, fontaine stadium 2, 3, or 4, with an indication for angioplasty or surgical reconstruction
Exclusion criteria
Disability to exercise as a result of peripheral arterial disease, serieus cardiac or pulmonary comorbidity (NYHA 3 and 4), other comorbidities that disable exercise therapy and inadequate knowledge of the Dutch language
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 | NL15104.096.06 |