Our primary research question is whether the cognitive skills, such as memory and planning skills, will improve by following the cognitive fitness training. Secondary research questions are aimed at improvements in physical and mental health,…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary research question is whether the cognitive skills improve by
following the cognitive fitness training. To identify the cognitive skills we
will take different cognitive tests with the research group. In the analysis we
will also create a composite variable in addition to the individual tests on
the basis of the following tests so that there will be one primary outcome
measure for the degree of cognitive functioning (Lindemayer et al, 2008; McGurk
et al, 2009). We take the following tests:
-Information processing speed: Trail Making Test, A and B (Eaton, et al. 2003);
-Verbal Learning, short term memory: 15 words test (Saan & Deelman, 1986);
-Attention, impulsiveness: Continuous Performance Test - Identical Pairs
(Cornblatt, 1989)
-Cognitive flexibility: Wisconsin Card Sorting Test (Banno, 2013; Berg, 1948)
Secondary outcome
Secondary research questions are aimed at improvements in physical and mental
health, physical activity, quality of life and pro active behavior. To do this,
we take a number of physical parameters namely:
-BMI (weight/length2); using scales and a linear measure
-Blood pressure measurement; using a digital blood pressure monitor (OMRON)
-Sub maximum strain test; a 6-minute walk test (ATS, 2002).
In addition we take the questionnaires below:
-Mental and physical health (EDGE-36);
-Quality of life, well-being (WHOQoL-bref);
-Degree of functioning: GAVE-score
-Physical activity (SQUASH; Wendel-Vos et al. 2002);
-Self-management: the scales "own wisdom" and 'self-management' from the Dutch
Empowerment List NEL
-Social participation: standardized questions about the living and working
situation and social contacts
Background summary
Clients of mental health institutions are struggling with problems in different
fields of life. In addition to the psychiatric problems many clients have
lifestyle related problems such as obesity, high blood pressure, diabetes and
lack of energy and inactivity (Appelo 2005; McGurk 2005; Daumit 2005; Keefe &
Fenton 2007; Saha 2008). The target group also relatively often has problems in
the field of cognitive functioning (planning, concentrating, learning, memory).
These problems in their turn have adverse consequences to the self esteem,
social participation and the eventual life expectancy of this target group; the
employment participation of the group is not much higher than 10-20% and the
life expectancy is more than 20 years lower than that of the general population
(McGurk 2005; Tiihonen 2009). Social work focuses on psychiatric problems and
practical support and relatively little on cognitive and somatic problems. The
fact that social workers proportionately pay little attention to this problem,
also has to do with a lack of interventions. The Multidisciplinary Directive
of Schizophrenia (2012), still only gives a few leads, especially in the field
of cognitive skills. During the last years it became more and more evident that
exercise has a positive impact on cognitive skills. The relationship between
movement and cognition is above all examined with the elderly. Various studies
(Angevaren 2008, Geda 2010, Ville 2008) show that sports and movement have a
favorable impact on the cognitive functioning of aged people. But also in
people with severe psychiatric disorders a beneficial effect of exercise on
cognitive functioning has been found in the meantime (Pajonk 2010); further
research into this relationship is recommended (Virus 2010). There is evidence
that exercise combined with cognitive stimulation further improves the
information processing capacity (Sitskoorn 2004).
So far, there are no studies within psychiatry in which an exercise
intervention is combined with a cognitive training. However, there are
indications in other target groups that precisely this combination is
effective. Three randomized controlled trials of such a combined training were
carried out with the elderly; these results of a combination training were more
favorable than the results of only a cognitive or physical training (Kain et
al., 2010; Fabre et al, 2002; Oswald et al, 2006). The latter study showed the
best results: improved cognitive functioning (d = 1.14), physical functioning
(d = 0.78) and psychosocial functioning (d = 0.47) (Oswald et al., 2006). A
possible explanation for this is that moving promotes the production of the
neurotrophines such as BDNF (brain-derived neurotrophic factor). This substance
also provides for the growth of neurons, besides protecting the nerve cells
(Lago 2010). In addition, people with schizophrenia have an increased risk of
abnormal glucose metabolism in the prefrontal cortex, also while performing
cognitive tasks (Heinrichs & Fuijmoto 2007, Davidson 2003). Because exercise
has beneficial effects on cardio metabole? functions in schizophrenia patients
(Scheewe et al, 2012; Hafeez et al, 2012), this is also an indication for a
beneficial effect of the combination of movement and training of cognitive
skills. These mechanisms are in line with the neurocognitive Cognitive Fitness
training method. This group training is developed by Body Brain dynamics
(www.cognitievefitness.nl) to promote the physical and mental condition based
on physical effort, intellectual challenge and relaxation exercises.
Study objective
Our primary research question is whether the cognitive skills, such as memory
and planning skills, will improve by following the cognitive fitness training.
Secondary research questions are aimed at improvements in physical and mental
health, physical activity, quality of life and pro active behavior. In
addition, we have an objective in the field of implementation. The original
training was conducted by the developers of cognitive fitness. Meanwhile, a
train-the trainers training is developed where employees of mental health
institutions are trained to become a cognitive fitness trainer. A research
question is whether the training courses are performed by the new trainers as
intended and to uncover any possible implementation barriers.
Study design
This study has a pre-post test design with no control group. There are 3
measurements; a measurement prior to the training, a measure immediately after
the training, and a final measurement. The aim of this last measurement is to
see whether the effect remains. So, the participants get a measurement 3
times, T0 (base-line), T4 (4 months after base-line) and T8 (8 months after
base-line). The power analysis indicates that there are about a 100
participants to be included. For the process evaluation, we will develop a
fidelity instrument. In the instrument there is attention for the parts:
treatment, teaching skills, structure and flexibility (responding to pace and
skills of the group), education about nutrition and the brain & boundary
conditions (facilities for the proper execution of the exercise). Each part is
composed of multiple items. Per item there is a number of criteria. Each item
can be scored from 1 to 5. Each feature will be awarded with a fidelity-score
on a three point scale; score 1 represents a low program integrity and score 3
represents a high program integrity. To map out the model fidelity, information
is gathered through interviews, observations and a short questionnaire.
Intervention
The training Cognitive Fitness consists of 15 weekly lessons. During these one
and a half hour sessions fitness exercises, breathing techniques and meditation
forms are combined with cognitive exercises that directly activate the brain.
In addition, the participants are given homework assignments. The workouts are
characterized by a gradual building-up, both in load and intensity. Despite the
fact that it is a group training, the pace, difficulty and guidance intensity
take into account the individual capabilities and limitations of participants.
The course is made up of 4 blocks. The first 3 blocks consist of 4 lessons,
focused on specific motor and cognitive skills (respectively memory and
concentration, logic and spacial insight and co-ordination and response
capacity). In Lesson 4 of these blocks the exercises from the first 3 lessons
are repeated. The repetition of prior learning moments is deliberately built
into the training program to ratify and deepen the lessons learned. During the
Cognitive Fitness training participants are challenged to learn new things. To
master this takes practice, and repetition is an important aspect. Repeat and
exercise ensure that the connections in the brain become stronger. Each
training session is built up of 4 parts. These parts are: the warming up, the
principal part, the cooling down and the subsequent discussion.
Study burden and risks
The intervention is not focused on the treatment of complaints. The exercises
in the intervention are aimed at strengthening cognitive skills and promoting
mental and physical fitness. For participants in the training Cognitive Fitness
there are three measurement waves?? moments. Each measurement contains a
questionnaire, neuropsychological and physical examination, costs up to 75
minutes, while the questionnaire can be completed independent of the other
tests. The measurements do not have risks. We also expect that the intervention
itself will cause no risks, but to be sure we will screen the participant
during the pre measurement for high blood pressure and we will ask whether they
are in treatment for somatic disorders.
Amstelplein 6
Amsterdam 1096 BC
NL
Amstelplein 6
Amsterdam 1096 BC
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria:
-Minimum age of 18 years
-Stability in medication use; at least 4 weeks prior to the inclusion of the research
-Physically able to exercise: people who are dependent on a wheelchair or have such a limitation that walking during the session of 1.5 hours is not possible cannot participate
-Motivation to participate in the whole course
-Sufficient mastery of the Dutch language to fill out questionnaires
Exclusion criteria
We do not have hard exclusion criteria regarding diagnosis and/or physical and cognitive fitness. The trainers of the Cognitive Fitness exercises are able to adapt to the individual level of the participant, hence we have no hard requirements with regard to physical fitness and/or restriction. However, the participant must be able to perform the exercises. People who are dependent on a wheelchair or have such a limitation that walking is not possible during the session of 1.5 hours are not recommended to participate. To establish this, those interested should have attended the information meeting in which they themselves experience what the training will demand from them.
Design
Recruitment
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In other registers
Register | ID |
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CCMO | NL47122.029.14 |