Fitforlife- a Study of Mentor Led Physical Exercise for Persons Affected by Psychosis
Phase: NA
Conditions: Psychotic Disorders
Sponsor: Karolinska Institutet

Study protocol 
 
Fitforlife; Peer–mentor driven physical exercise for persons affected 
by psychosis. 
1.6.2019 
 
 

 
Administrative details: See separate information 
 
Project summary: See separate information 
 
Background 
Psychosis 
Psychosis is a severe mental disorder with the main and common symptom being loss of 
reality testing due to misinterpretation of perception. The disorder is often accompanied by 
more or less life-long social impairment and decreased level of functioning. No biological 
correlates are available so the diagnosis is based on the presence of symptoms. The most 
serious form of psychosis, schizophrenia, has a lifetime prevalence of 5.5(SD 4.5) in 1000 
persons and the incidence is 23.7(SD 30.3) in 100 000 persons. Mean age of onset is 18 years 
in men and 25 in women. Schizophrenia is associated with elevated suicide rates and an 
increased risk of premature death related to a wide range of somatic conditions, mainly 
depending on increased metabolic risk factors. The median standardized mortality ratio is 2.6 
for all-cause mortality and this differential gap has increased over the recent decades. Several 
modifiable unhealthy life style factors are more prominent in individuals with schizophrenia, 
such as smoking, unhealthy dietary habits and decreased physical activity. Tobacco use and 
weight gain/obesity has also been shown to be associated with increased severity of symptoms 
and decreased level of functioning.  
Cognitive impairment represents a core feature in schizophrenia with individuals experiencing 
various degrees of decline from expected level of cognitive functioning. The majority (70 %) 
function at a level at least one standard deviation below that of healthy controls, with 
impairment already present in first-episode psychosis, and enduring after pharmacological 
treatment. Impairments are found in the domains of attention, verbal learning, memory, 
working memory, processing speed, problem solving/executive functioning and social 
cognition, in addition to a global cognitive deficit. The presence of cognitive impairments is 
further associated with a more severe course of illness and a higher rate of use of health 
services. Cognitive impairment is a prominent predictor of functional outcome in psychotic 
disorders and may strongly affect the level of independence the affected persons can achieve 
in their lives. Intact cognition is essential for occupational performance and academic 
functioning, hence cognitive deficits are frequently associated with unemployment and 
curtailed level of education.  
Depression is a common comorbidity in schizophrenia with reported rates of 25-81%. Persons 
affected by comorbidity have lower levels of medication adherence, more substance related 
problems, poorer social and family relationships and poorer quality of life. 
Another problem in schizophrenia is the tendency of relapses. Many individuals with 
schizophrenia have several relapses resulting in multiple hospital stays, making it a leading 
cause of disability worldwide. 
The stress-diathesis model suggests that lowering biological vulnerability or reducing stress 
can prevent relapses. Most of the used strategies, such as antipsychotic medication and 
avoiding substance abuse, focus on biological vulnerability. During the past three decades’ 
psychosocial interventions have emerged focusing on increasing resilience to stress and 
building social support. These strategies often involve support for life style changes targeting 
smoking cessation, dietary habits and physical exercise. Advice on physical exercise are 
however often general and only very rarely organized exercise sessions are offered. 
In summary there are three areas of suboptimal management of people with schizophrenia; 1) 
lack of effective treatments for negative symptoms and cognitive dysfunction, 2) only 
partially effective treatment for positive symptoms 3) high rates of physical health problems, 
particularly cardiovascular disease. 
 

Recovery 
The non-linear process of recovery needs to be consumers led. This means that the traditional 
medical and psychosocial rehabilitation model needs to be abandoned. The care system need 
to provide the tools and support when needed but the responsibility should lie on the affected 
person. In other care disciplines the patients’ autonomy is well respected but psychiatry lags 
behind.  
 
Stigma 
All persons develop conception of mental illness early in life and form expectations of rejection. If 
affected this fear of rejection will have serious negative consequences. Such consequences are decreased 
self-esteem, self-efficacy and recovery orientation. Another consequence is social phobia, which is a very 
common comorbid disorder in schizophrenia. Stigma is an important factor in the decreased social 
capability, hindering studies and employment. 
 
Physical exercise 
Aside from the effects on the cardiovascular and muscular system, physical activity also has 
several neurobiological effects. It is reported to modulate the Hypothalamic-pituitary-renal 
(HPA) axis, which is a part of the stress-response system. It also affects the serotonergic drive 
thus acting like an antidepressant. The neural growth factor expression is increased by 
physical exercise affecting the neurogenesis in the brain. This effect can be seen in studies 
showing enhanced cognition (learning and memory) in healthy persons. There are numerous 
psychological effects such as increased wellbeing and heightened motivation and diversion 
from negative thoughts. However, physical activity is a complex behavior, including exercise 
(high-intensity, short-term bouts of physical activity, often structured), everyday physical 
activity (including those from daily chores, traveling, work and leisure time), as well as 
sedentary behaviors. In addition, physical fitness (primarily aerobic fitness) is a consequence 
of those behaviors and may well have it´s own independent relation and effect on cognition, 
sleep and mood. 
 
Physical exercise as a treatment in psychosis 
A recently reported pilot study in young persons at high risk for psychosis showed 
improvement in positive and negative symptoms, social and role functioning, performance on 
neurocognitive tests and cardiovascular fitness. 
 
Thus far, only few studies have examined physical exercise in psychosis and differences in 
methodology makes them difficult to compare. A Cochrane Review from 2010 concluded that 
regular exercise programs are possible and may potentially have beneficial effects on both 
physical and mental health as well as overall wellbeing. However, only 3 studies fulfilled the 
inclusion criteria with small sample sizes and the exercise conditions and outcome measures 
differed. A systematic review and meta-analysis from 2014 including 8 studies showed only a 
modest increase in levels of exercise activity and no changes in symptoms or Body Mass 
Index (BMI). However, the included studies varied in exercise programs, age groups, sample 
size and outcome measures.  
Cognitive functioning after exercise has only rarely been the focus with only one small study 
reporting a 34% improvement in short-term memory.  
The treatment potential is large since individuals affected with serious mental illness are more 
likely to be sedentary than the general population. 
 
Preliminary results Fitforlife pilot study 
During 2015-2016, 99 participants were included. A majority were males (60 persons) and the 
mean age was 28.2 years. The study was originially designed as a waiting list study but due to 

problems with the open care units this turned out to be impossible. Of the 99 persons 39 did 
not attend any sessions, the rest attended between 1-52 sessions, mean 13.1(SD 12.1). 
Trailmaking A test time (visual attention) improved 8.5 seconds (SD 20.4) in those that 
attended >1 session and 5.4 (SD 6.5) in those that did not attend. Trailmaking B, (visual 
attention and task shifting), improved 10.4 seconds (SD 42.8) in attenders versus 4.6 (SD 
31.7) in non-attenders.  
Camberwell assessment of need showed that at the initial examination 33 persons reported 
difficulties with social contacts while at the end of the intervention 17 of those reported no 
problems. Likewise, 24 persons reported problems with close relations at baseline while 11 of 
them reported no problem at the end. In the proposed study this will be measured in a more 
extensive way. During an open house for participants and relatives there were reports about 
improvment in daily life such as ”started to care about his looks”, ”cleans his room”. During 
spring 2017 the cognitive tests will be analysed and linked with inflammatory markers. The 
study has given us experience on how to organise exercise for persons with psychosis.  
After the first wave four participants were educated as peer mentors. At least one peer-mentor 
was present in all sessions in wave two and three. The peer mentors were responsible for 
organizing parts of the sessions under supervision of educated trainers. Since the study 
finished the mentors have worked as peer mentor trainers, offering sessions to patients at an 
open care unit for FEP. The staff promote the sessions during their meetings with their 
patients and discussion about physical activity levels is a part of all patients’ individual care 
programme.  
 
Study objectives: See separate information 
 
Methodology 
 
Study design: Non randomized open trial. 
Study population: Patients affected by psychosis at open care psychiatric units who are 
responsible for taking care of psychosis in Sweden.  
Sample size: Our aim is to recruit 300 patients including mentors at each unit. 
 
Variables list including data collection tools:  
1. From the medical records: age, gender, diagnosis, time of first contact with psychiatry, 
medication 
• App questions on overall function using WHODAS 2.0 
• App question on social network: qualitative and quantitative 
• App questions: smoking, alcohol consumption and illicit drug use 
• Cognitive tests: Cogstate (performed at a computer) and Trail making A and B 
• Submaximal fitness test: Åstrand 
• Physical activity pattern, including sedentary time, low-intensity physical activity and 
exercise, assessed by a simple accelerometer on a subsample.  
• Body measurements: length, weight, hip-waist measure, blood pressure. 
• Blood samples: Blood lipids, HBA1C, TNFalfa, CRP, Il-6 
 
Plan of analyses: See separate information 
 
Intervention including time plan 
 
A team consisting of one of the mentors from Fitforlife, a health pedagogic, and one or two 
from the research group will come to each included open care unit. 
Day 1; Upstart meeting led by a research group member.  

Day 1-4; Education of the new mentors led by the health pedagogic assisted by mentor(s) 
from Fitforlife pilot study. 
Day 1-5; Baseline examinations (see above for data collection tools) of all the potential 
participants by the local contact person(s). 
Day 5-14; Start of the training. Initially supported by the health pedagogic and the mentor(s) 
from Fitforlife pilot study. 
 
Day 14-70: Training sessions led by the local mentors. Supported by phone and online by the 
health pedagogics and the mentors from Fitforlife. During this time 1-3 visit(s) from the 
health pedagogic to each mentor during a training session. 
 
Day 70-75: Follow up assessments by the local contact person. 
 
Measurements during the intervention 
Compliance will be measured by the local coordinators. In a subgroup objective measures of 
physical activity using simple accelerometers will be performed. 
Before and after each training session the participant will be asked to answer simple App 
based questions - “How do you feel” (happy, tired etc). 
 
Long term follow-up- 12 months  
The participants will be followed using medical records.  
 
 
Strengths and limitations 
Largest study of physical exercise in psychosis. Using an entirely new concept, patients lead 
phsycial exercise.  
Not randomized due to practical issues. Impossible to randomize patients within a unit, many 
ongoing group activities. Differences between units in care programme large making cluster 
randomizatiion difficult.  
 
Ethical permission: See separate information