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.

Study Overview

• Status: Recruiting
• Conditions: Bipolar Disorder; Schizophrenia and Related Disorders
• Intervention / Treatment: Other: High intensity training (HIT)

Detailed Description

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
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erik Johnsen, PhD; Phone Number: 004792456225; Email: erik.johnsen@helse-bergen.no
• Study Contact Backup: Name: Rune A Kroken, PhD; Phone Number: 004792095205; Email: rune.andreas.kroken@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway, 5020
    • Recruiting
    • Haukeland University Hospital
    • Contact: Erik Johnsen, MD, PhD; Phone Number: +47 55958400; Email: erik.johnsen@helse-bergen.no
    • Contact: Rune A Kroken, MD, PhD; Phone Number: +47 55958400; Email: rune.andreas.kroken@helse-bergen.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard HIT; 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.	Other: High intensity training (HIT); Please see information already included in the arm descriptions.
Experimental: Short HIT; 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.	Other: High intensity training (HIT); Please see information already included in the arm descriptions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Proportion (number and percent) of completers at 26 weeks.	26 weeks

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2023
• Primary Completion (Estimated): September 26, 2026
• Study Completion (Estimated): September 26, 2026

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Effectiveness; Exercise therapy
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Mood Disorders; Schizophrenia; Bipolar Disorder; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Conditioning, Human; Exercise; High-Intensity Interval Training
• Other Study ID Numbers: REK nr. 428096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No