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NCT Number: NCT06313918

Exercise Therapy in Mental Disorders-study

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ICD-10 schizophrenia-spectrum disorder (F2)
  • ICD-10 bipolar disorder (F3)
  • Capacity to provide informed consent.

Exclusion criteria

  • Contra-indication for exercise training and testing according to the American College of Sports Medicine specifications
  • Life threatening or terminal medical conditions
  • Not able to carry out intervention or test procedures
  • Current pregnancy
  • Mothers less than 6 months post-partum.

Treatment and study plan

High intensity training (HIT)

Other

Please see information already included in the arm descriptions.

Primary outcomes

  1. Adherence

    Time frame: 26 weeks

    Proportion (number and percent) of completers at 26 weeks.

Secondary outcomes

  1. Change of the Simplified Negative and Positive Symptoms Interview (SNAPSI) score

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Symptoms of psychosis

  2. Change of the Calgary Depression Scale in Schizophrenia score

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Symptoms of depression

  3. Change of the Clinical Global Impression (CGI) score

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Overall clinical state

  4. Change of the Global Assessment of Funtioning (GAF) score

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Functioning

  5. Change of quality of life (QOL10) score

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Quality of life

  6. Change of the International Physical Activity Questionaire (IPAQ) score

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Physical activity

  7. Change of the Brief Assessment of Cognition in Schizophrenia (BACS) score

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Cognition

  8. Change of the Behavioural Regulation in Exercise Questionaire (BREQ) score

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Motivation

  9. Change of the Difficulties in Emotion Regulation (DERS) score

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Emotion regulation

  10. Change in heart rate (beats per minute)

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Heart rate variability

  11. Change of maximal oxygene extraction (VO2max)

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Aerobic capacity

  12. Change of level of inflammatory markers in blood

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Inflammation

  13. Change of body weight (kilograms)

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Body weight change

  14. Change of hip- and waist circumference (centimetres)

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Change of hip- and waist circumference

  15. Change of serum glucose (mmol/L)

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Change of serum glucose

  16. Change of serum cholesterols (mmol/L)

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Change of serum cholesterols

  17. Change of serum triglyceride (mmol/L)

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Change of serum triglyceride (mmol/L)

  18. Change of gene expression

    Time frame: 4, 12, 26 and 52 weeks from baseline

    RNA

  19. Change of methylation of DNA

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Epigenetic changes

  20. Change of the Young Mania Rating Scale (YMRS) score

    Time frame: 4, 12, 26 and 52 weeks from baseline

    Symptoms of mania

Study contacts

Contact information is provided by the study sponsor or research team.

Erik Johnsen, PhD

CONTACT

[email protected]

004792456225

Rune A Kroken, PhD

CONTACT

[email protected]

004792095205

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 15, 2024
Registry last updated
Dec 30, 2025

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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