The study will compare standard high-intensity training with brief high-intensity training in people with schizophrenia-spectrum or bipolar disorder. The overall aim is to determine which of the two is superior in a long-term perspective.
Background: Patients with severe mental disorders (SMD), including schizophrenia spectrum and bipolar disorders, frequently experience suboptimal treatment effectiveness resulting in disabling residual symptoms and cognitive challenges, and have elevated mortality risk amounting to 15-20 years of shortened life expectancy compared to the general population. Cardiovascular disease (CVD) is a major contributor in this regard. Exercise in general improves cognitive functioning, negative symptoms, quality of life, and reduces the risk of CVD. High intensity training (HIT) has been shown to be feasible for persons with SMD, but attrition and noncompliance are substantial and likely to limit the effectiveness of HIT. A less strenuous HIT could increase adherence to the intervention, which might compensate for a slightly lower efficacy compared to standard HIT. Our study will compare standard 4x4-min HIT to a 4-min single-bout HIT session, as well as explore exercise effects on basic processes in the body. Methods: Patients with schizophrenia spectrum and bipolar disorders are eligible for participation, and those included will be randomized to 26 weeks of either 1) Standard 4 x 4 min HIT at treadmill, or 2) Short 1 x 4 min HIT at treadmill. To reduce dropout, the intervention will usually be delivered in group format, and conducted under the supervision of a physical therapist in collaboration with a postdoctor. The research group has a stable staff with research nurses, biostatisticians and researchers that will secure the dayto- day conductance of the project, including psychometric assessments, drawing of and biobanking of blood, as well as data collection and storing. Measures: Mental and cognitive symptoms, quality of life, motivation, Peak oxygen uptake (V
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Please see information already included in the arm descriptions.
Haukeland University Hospital
Bergen, Norway
RECRUITINGAdherence
Proportion (number and percent) of completers at 26 weeks.
Time frame: 26 weeks
Change of the Simplified Negative and Positive Symptoms Interview (SNAPSI) score
Symptoms of psychosis
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of the Calgary Depression Scale in Schizophrenia score
Symptoms of depression
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of the Clinical Global Impression (CGI) score
Overall clinical state
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of the Global Assessment of Funtioning (GAF) score
Functioning
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of quality of life (QOL10) score
Quality of life
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of the International Physical Activity Questionaire (IPAQ) score
Physical activity
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of the Brief Assessment of Cognition in Schizophrenia (BACS) score
Cognition
Time frame: 4, 12, 26 and 52 weeks from baseline
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Change of the Behavioural Regulation in Exercise Questionaire (BREQ) score
Motivation
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of the Difficulties in Emotion Regulation (DERS) score
Emotion regulation
Time frame: 4, 12, 26 and 52 weeks from baseline
Change in heart rate (beats per minute)
Heart rate variability
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of maximal oxygene extraction (VO2max)
Aerobic capacity
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of level of inflammatory markers in blood
Inflammation
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of body weight (kilograms)
Body weight change
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of hip- and waist circumference (centimetres)
Change of hip- and waist circumference
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of serum glucose (mmol/L)
Change of serum glucose
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of serum cholesterols (mmol/L)
Change of serum cholesterols
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of serum triglyceride (mmol/L)
Change of serum triglyceride (mmol/L)
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of gene expression
RNA
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of methylation of DNA
Epigenetic changes
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of the Young Mania Rating Scale (YMRS) score
Symptoms of mania
Time frame: 4, 12, 26 and 52 weeks from baseline