Haukeland University Hospital
Bergen, 5020, Norway
Location status: Recruiting
Location contact
Erik Johnsen, MD, PhD
CONTACT
Rune A Kroken, MD, PhD
CONTACT
NCT Number: NCT06313918
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.
Interested in participating?
Request Info16 year and older
All sexes
Interventional
Not applicable
Bergen, 5020, Norway
Location status: Recruiting
Erik Johnsen, MD, PhD
CONTACT
Rune A Kroken, MD, PhD
CONTACT
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Please see information already included in the arm descriptions.
Time frame: 26 weeks
Proportion (number and percent) of completers at 26 weeks.
Time frame: 4, 12, 26 and 52 weeks from baseline
Symptoms of psychosis
Time frame: 4, 12, 26 and 52 weeks from baseline
Symptoms of depression
Time frame: 4, 12, 26 and 52 weeks from baseline
Overall clinical state
Time frame: 4, 12, 26 and 52 weeks from baseline
Functioning
Time frame: 4, 12, 26 and 52 weeks from baseline
Quality of life
Time frame: 4, 12, 26 and 52 weeks from baseline
Physical activity
Time frame: 4, 12, 26 and 52 weeks from baseline
Cognition
Time frame: 4, 12, 26 and 52 weeks from baseline
Motivation
Time frame: 4, 12, 26 and 52 weeks from baseline
Emotion regulation
Time frame: 4, 12, 26 and 52 weeks from baseline
Heart rate variability
Time frame: 4, 12, 26 and 52 weeks from baseline
Aerobic capacity
Time frame: 4, 12, 26 and 52 weeks from baseline
Inflammation
Time frame: 4, 12, 26 and 52 weeks from baseline
Body weight change
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of hip- and waist circumference
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of serum glucose
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of serum cholesterols
Time frame: 4, 12, 26 and 52 weeks from baseline
Change of serum triglyceride (mmol/L)
Time frame: 4, 12, 26 and 52 weeks from baseline
RNA
Time frame: 4, 12, 26 and 52 weeks from baseline
Epigenetic changes
Time frame: 4, 12, 26 and 52 weeks from baseline
Symptoms of mania
Contact information is provided by the study sponsor or research team.
Erik Johnsen, PhD
CONTACT
Rune A Kroken, PhD
CONTACT
Haukeland University Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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