The main objective is to examine determinants of physical behaviour in patients with SAH (primary in patients with A-SAH and secondary in patients with PM-SAH). Secondary, preferences of patients for therapy to reduce fatigue will be explored in…
ID
Source
Brief title
Condition
- Vascular haemorrhagic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To examine determinants of physical behaviour, physical behaviour will be
determined objectively and self-reported (accelerometry-based activity
monitoring and electronic diary). As possible determinants the following
outcomes will be assessed (questionnaires, semi-structured interview): fatigue
(2 outcomes), sleep quality, activities, participation, health-related quality
of life, social support, anxiety (2 outcomes), illness perception, depression,
coping style, motivation (2 outcomes), self-efficacy and health condition (3
outcomes).
Secondary outcome
Secondary, preferences of patients for therapy to reduce fatigue will be
explored regarding time investment, location, type, frequency and duration of
therapy (semi-structured interview). In addition, physical fitness in terms of
cardiorespiratory fitness (cardiopulmonary exercise test) and muscle strength
(muscle strength test) will be assessed.
Background summary
With a prevalence ranging from 31% to 90%, fatigue is one of the most common
long-term sequelae in both patients with aneurysmal and perimesencephalic
subarachnoid haemorrhage (A-SAH and PM-SAH). Fatigue in these patients is
strongly correlated with a decreased health-related quality of life and poorer
scores on cognitive functioning, depression and comorbidity. There is no
rehabilitation program (either physical, cognitive, or multidisciplinary) that
is specifically developed to treat fatigue in patients with SAH. Therapies
aimed at fatigue in other neurologic conditions revealed inconsistent effects.
This may be due to the multifactorial concept of fatigue, which makes it
difficult to determine the best treatment procedure. Given previous studies
indicating a physical origin of fatigue in patients with A-SAH, incorporating
physical activity (including physical fitness training) in a rehabilitation
program might be beneficial to treat fatigue. However, before developing such a
rehabilitation program for people with SAH, insight in determinants of physical
activity (PA) behaviour in this population is a prerequisite. Therefore, the
primary aim of this study is to examine determinants of physical behaviour in
patients with SAH. The study is based on *The Physical Activity for people
with a Disability (PAD) model*, which captures determinants of PA behaviour in
people with a disability. In addition, preferences of SAH patients for therapy
to reduce fatigue will be explored regarding time investment, location, type,
frequency and duration of therapy. To examine if a rehabilitation program
(including physical activity) should also target patients with PM-SAH, physical
fitness and physical behaviour, and their relation with fatigue will be
explored in this subgroup.
Study objective
The main objective is to examine determinants of physical behaviour in patients
with SAH (primary in patients with A-SAH and secondary in patients with
PM-SAH). Secondary, preferences of patients for therapy to reduce fatigue will
be explored in patients with SAH, and physical fitness and physical behaviour,
and their relation with fatigue will be explored in patients with PM-SAH.
Study design
Cross-sectional design with measurements in the home-situation and in the
clinical movement laboratory.
Study burden and risks
Patients will be visited at home once (2.5 hours), to fill in questionnaires
and answer additional questions in a semi-structured interview. If necessary,
patients will get rest between the questionnaires, therefore the burden is
considered low. Comparable (numbers of) questionnaires have been conducted
before in patients with SAH, this was found feasible. In addition, patients
wear an accelerometer on the upper leg for seven consecutive days and fill out
an electronic diary during those seven days. Wearing the accelerometer for
seven consecutive days does not increase risk or burden for the patient,
because the accelerometer is a small and light-weighted device and patients are
not forced to perform other activities than in normal life. Filling out the
electronic diary has been found feasible in a comparable study from our
research group with stroke patients. For testing physical fitness and physical
behaviour, a subgroup of patients will perform a progressive cardiopulmonary
exercise test (CPET) and a muscle strength test (MST). Patients will be
screened by a physician prior to the CPET and MST to examine medical
contraindications. If there is any suspicion of an underlying cardiovascular or
pulmonary pathology, the tests will not be carried out. During the CPET, blood
pressure and heart function will be monitored and a sport physician will
provide emergency back-up. Patients will get enough rest between the tests.
Both the CPET and MST test may cause temporary fatigue, but the risk is
considered low. All tests have been performed before in A-SAH patients, without
any adverse events. The patients will not benefit directly from participating
in the study, they will gain insight in their physical behaviour and
determinants and their physical functioning. The results will serve as input
for the development of a rehabilitation program to reduce fatigue. When a
rehabilitation program will be tested in a follow-up study, a subgroup of
patients can be invited to participate.
Westersingel 300
Rotterdam 3015 LJ
NL
Westersingel 300
Rotterdam 3015 LJ
NL
Listed location countries
Age
Inclusion criteria
- Admitted and treated/controlled at the neurology or neurosurgery departments of Erasmus MC or Elisabeth-TweeSteden Ziekenhuis and/or receiving rehabilitation at Rijndam Revalidatie or Libra Revalidatie and Audiologie;
- Between 3 and 12 months post A-SAH onset;
- At least 3 months post PM-SAH onset;
- Living at home;
- Only for patients with A-SAH; experience and report fatigue symptoms;
- SAH diagnosed by computed tomography and if negative, by a lumbar puncture followed by a computed tomography angiography or digital subtraction angiography to detect the aneurysm (A-SAH). PM-SAH diagnosed by accumulation of blood around the mesencephalon on computed tomography and a normal four vessel angiogram;
- At least 18 years of age.
Exclusion criteria
- 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)
Extra exclusion criteria regarding the cardiopulmonary exercise test and muscle strength test in patients with PM-SAH:
- Aged >= 70 years;
- Not eligible for maximal exercise testing, as determined by the treating physician, the Physical Activity Readiness Questionnaire (PAR-Q) and a checklist for medical contra-indications based on the ACSM guidelines for Exercise Testing and Prescription.
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 | NL62745.078.17 |