Primary aim: Examine whether and to what extent fatigue and quality of life of patients with SAH improve after participating in RE-SAB.Secundary aims: (1) Examine whether and to what extent physical activity level, physical fitness, coping style,…
ID
Source
Brief title
Condition
- Vascular haemorrhagic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Fatigue and Quality of Life
Secondary outcome
Self-efficacy, mood, cognition, coping style, (social) participation, illness
perception, therapy expectancy, physical fitness, physical activity, patient
satisfaction and practical feasibility.
Background summary
A subarachnoid haemorrhage (SAH), a stroke subtype, has a major impact on the
patient's life, with fatigue as one of the most commonly reported long-term
symptoms. Fatigue leads to impairments in education/work and in social and
personal activities and to a reduction in quality of life. Treating fatigue
should therefore be an important part of rehabilitation after SAH. However,
there is no suitable rehabilitationprogram avalaible for these patients. Most
of the patients are discharged from the hospital to their home, without
receiving rehabilitation. Based on previous studies a rehabilitation program is
developed, named RE-SAB, with the aim to reduce fatigue and improve quality of
life.
Study objective
Primary aim: Examine whether and to what extent fatigue and quality of life of
patients with SAH improve after participating in RE-SAB.
Secundary aims: (1) Examine whether and to what extent physical activity level,
physical fitness, coping style, cognition, mood, self-efficacy, (social)
participation, illness perception and therapy expectancies of patients with SAH
improve after participating in RE-SAB; (2) Examine how RE-SAB is experienced by
patients with SAH in terms of patience satisfaction and therapy compliance; (3)
Examine whether RE-SAB is practicably feasible.
Study design
The study is a pilot intervention study, for which patients with fatigue
complaints after a SAH will be invited to participate. Three measurements will
be conducted; before the start of the intervention (T0) and after 3 (T3) and 6
(T6) months of the intervention.
Intervention
The intervention will last 6 months en consists of 24 times fitness training, 6
coach sessions and 3 information sessions. In the first period of 3 months, the
patient will perform the fitness training and he/she will receive 4 coach
sessions and 1 information session. In the second period of 3 months, the
patient will receive 2 coach sessions and 2 information session.
Study burden and risks
Participating in the intervention requires physical effort and time investment
(total 23-40 hours) of the patient. This may result in a temporarily increase
in fatigue. To keep the burden as low as possible, the fitness training is
organised close to the home of the patient. In addition, visits (measurement
and/or coach- and informationsessions) will be combined and patients will get
enough rest between the tests. All patients are screened by a doctor and
receive a personal training advice to prevent overtraining (e.g. muscle pain).
The (physical) therapist follows this training advice. After each measurement
patients wear an acceloremeter and fill in an electronic diary during one week.
There are no risks involved with this. Patients can perform all daily life
activities (including showering) during this week. An intervention study that
was comparable in design, but where the fitness training was performed in the
rehabilitation center, was found feasible in people with Cerebral Palsy
(MEC-2009-079). We expect patients to benefit directly from the intervention in
several aspects, including fatigue and quality of life, and that the benefits
of participation outweigh the burden.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Admitted and treated/controlled at the neurology or neurosurgery department
of Erasmus MC;
- Diagnosed with a subarachnoid haemorrhage (SAH) by computed tomography or if
negative, by a lumbar puncture;
- Experience fatigue symptoms;
- At least 18 years of age;
- Living at home.
Exclusion criteria
- > 2 years post SAH onset;
- Traumatic SAH;
- Previous stroke;
- Serious chronic disease (including neurological diseases);
- Insufficient mastery of the Dutch language;
- Inability to understand verbal instructions and/or fill in the questionnaires
(clinical judgement by neurologist).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL68780.078.19 |
| OMON | NL-OMON20856 |