The primary aim of this study is to evaluate the effects of a structured, progressive task-oriented fitness training program applied in a group of 8 to 10 patients on perceived outcome of mobility after stroke when compared to individually-tailored…
ID
Source
Brief title
Condition
- Neurological disorders NEC
- Vascular haemorrhagic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome will be the Stroke Impact Scale (mobility part) and cost
effectiveness (EuroQoL).
Secondary outcome
endurance, gait speed, muscle strength of lower limbs, chair rising and stair
climbing tests, confidence not to fall, instrumental ADL, fatigue, anxiety and
depression, and health perception in general.
Background summary
The number of stroke patients in the Netherlands is 7.5 per 1000 inhabitants
and keeps increasing (Struijs 2005). With that costs increase too, and these
costs are suspected to be over one billion Euros (Evers 2004). Previous
studies show that walking ability is often diminished in these patients and
with that mobility too (vd Port, Lord, Kwakkel). A qualitative study showed
that loss of independence in mobility is one of the most invalidating factors
for patients with stroke. (Pound). In addition will inactivity lead to
secondary complications like loss of endurance, muscle atrophy, osteoporoses
and circulation problems of the lower extremities. (Gordon) and with that
quality of life in general. A meta-analysis showed that task-oriented circuit
training in groups is effective in improving walking competency after stroke
(van de Port). However, the effects of interventions in chronic stroke patients
and the cost effectiveness of these programs compared have hardly been
investigated.
Study objective
The primary aim of this study is to evaluate the effects of a structured,
progressive task-oriented fitness training program applied in a group of 8 to
10 patients on perceived outcome of mobility after stroke when compared to
individually-tailored physiotherapy in the community. The second aim is to
examine the cost-effectiveness.
Study design
A multicentre single blinded randomised clinical trial.
Intervention
Group training containing 8 to 10 workstations focused on improving balance,
walking ability, walking related activities like transfers, climbing stairs
and endurance. The program will be tailor-made considering the ability of the
patient. Important is that the program can be progressive by adding weight, or
increasing the number of repetitions. The program will last 12 weeks with two
sessions of 90 minutes per week. During this period the patient holds a dairy
about activities and special remarks that might influence the results.
Study burden and risks
The intervention given in this research project is believed to be comparable to
the regular physical therapy intervention when considered burden for the
patient. The patients will have to fill out some questionnaires which will not
give much burden. Also some physical test are included of which the main part
includes tests that are part of regular physical therapy (6 minute walking
test, 10 meter walking test, motricity index). We therefore have the opinion
that the extent of burden is not too heavy for these patients. Risks associated
with participation in this study are minor.
Heidelberglaan 100
3508 GA Utrecht
NL
Heidelberglaan 100
3508 GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
Patients after stroke during inpatient rehabilitation
age over 18 years
being able to walk at least 10 m independently (Functional Ambulation Categories >=4)
Being motivated to follow 24 session of physical therapy expressed by signing informed consent
Exclusion criteria
Cognitive problems (Mini Mental State Examination <24 punten)
Subarachnoidale haemorrhage
Communication problems (Utrecht Communicatie Onderzoek < 4 punten)
Patients living more than 30 km from the rehabilitation centre
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 | NL20850.041.07 |