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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard HIT | Active Comparator | Standard 4 x 4 min HIT at treadmill. First 7 min warm-up, then 4 sessions with 4 min walking/running at 80-95% of maximal heart rate, with 3 min of active rest in between. Ending with 5 min of cooling down. Two sessions per week for 26 weeks. |
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| Short HIT | Experimental | Short 1 x 4 min HIT at treadmill. Starting with 7 min warm-up walking/running, then 1 session with 4 min walking/running at 80-95% of maximal heart rate, ending with 5 min of cooling down. Two sessions per week for 26 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High intensity training (HIT) | Other | Please see information already included in the arm descriptions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Proportion (number and percent) of completers at 26 weeks. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the Simplified Negative and Positive Symptoms Interview (SNAPSI) score | Symptoms of psychosis | 4, 12, 26 and 52 weeks from baseline |
| Change of the Calgary Depression Scale in Schizophrenia score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erik Johnsen, PhD | Contact | 004792456225 | erik.johnsen@helse-bergen.no | |
| Rune A Kroken, PhD | Contact | 004792095205 | rune.andreas.kroken@helse-bergen.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Recruiting | Bergen | 5020 | Norway |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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Open label, two-arm, parallel group, randomised trial, to compare standard and short HIT during 26 weeks of supervised exercise. The group will receive comprehensive follow-up to be able to carry out the 26 weeks exercise intervention program. Outcome measures will be taken at; baseline (T0), 4 weeks (T1), 12 weeks (T2), 26 weeks (T3), and 52 weeks (T4) post randomisation.
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Symptoms of depression
| 4, 12, 26 and 52 weeks from baseline |
| Change of the Clinical Global Impression (CGI) score | Overall clinical state | 4, 12, 26 and 52 weeks from baseline |
| Change of the Global Assessment of Funtioning (GAF) score | Functioning | 4, 12, 26 and 52 weeks from baseline |
| Change of quality of life (QOL10) score | Quality of life | 4, 12, 26 and 52 weeks from baseline |
| Change of the International Physical Activity Questionaire (IPAQ) score | Physical activity | 4, 12, 26 and 52 weeks from baseline |
| Change of the Brief Assessment of Cognition in Schizophrenia (BACS) score | Cognition | 4, 12, 26 and 52 weeks from baseline |
| Change of the Behavioural Regulation in Exercise Questionaire (BREQ) score | Motivation | 4, 12, 26 and 52 weeks from baseline |
| Change of the Difficulties in Emotion Regulation (DERS) score | Emotion regulation | 4, 12, 26 and 52 weeks from baseline |
| Change in heart rate (beats per minute) | Heart rate variability | 4, 12, 26 and 52 weeks from baseline |
| Change of maximal oxygene extraction (VO2max) | Aerobic capacity | 4, 12, 26 and 52 weeks from baseline |
| Change of level of inflammatory markers in blood | Inflammation | 4, 12, 26 and 52 weeks from baseline |
| Change of body weight (kilograms) | Body weight change | 4, 12, 26 and 52 weeks from baseline |
| Change of hip- and waist circumference (centimetres) | Change of hip- and waist circumference | 4, 12, 26 and 52 weeks from baseline |
| Change of serum glucose (mmol/L) | Change of serum glucose | 4, 12, 26 and 52 weeks from baseline |
| Change of serum cholesterols (mmol/L) | Change of serum cholesterols | 4, 12, 26 and 52 weeks from baseline |
| Change of serum triglyceride (mmol/L) | Change of serum triglyceride (mmol/L) | 4, 12, 26 and 52 weeks from baseline |
| Change of gene expression | RNA | 4, 12, 26 and 52 weeks from baseline |
| Change of methylation of DNA | Epigenetic changes | 4, 12, 26 and 52 weeks from baseline |
| Change of the Young Mania Rating Scale (YMRS) score | Symptoms of mania | 4, 12, 26 and 52 weeks from baseline |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |