Exercise Therapy in Mental Disorders-study

Bipolar Disorder Clinical Trial

Official title:

Exercise Therapy in Mental Disorders-study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313918
• Other study ID #: REK nr. 428096
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2023
• Est. completion date: September 26, 2026

Study information

• Verified date: March 2024
• Source: Haukeland University Hospital
• Contact: Erik Johnsen, PhD
• Phone: 004792456225
• Email: erik.johnsen[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 26, 2026
• Est. primary completion date: September 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia and Related Disorders

Intervention

Other:
• High intensity training (HIT)
Please see information already included in the arm descriptions.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Proportion (number and percent) of completers at 26 weeks.	26 weeks
Secondary	Change of the Simplified Negative and Positive Symptoms Interview (SNAPSI) score	Symptoms of psychosis	4, 12, 26 and 52 weeks from baseline
Secondary	Change of the Calgary Depression Scale in Schizophrenia score	Symptoms of depression	4, 12, 26 and 52 weeks from baseline
Secondary	Change of the Clinical Global Impression (CGI) score	Overall clinical state	4, 12, 26 and 52 weeks from baseline
Secondary	Change of the Global Assessment of Funtioning (GAF) score	Functioning	4, 12, 26 and 52 weeks from baseline
Secondary	Change of quality of life (QOL10) score	Quality of life	4, 12, 26 and 52 weeks from baseline
Secondary	Change of the International Physical Activity Questionaire (IPAQ) score	Physical activity	4, 12, 26 and 52 weeks from baseline
Secondary	Change of the Brief Assessment of Cognition in Schizophrenia (BACS) score	Cognition	4, 12, 26 and 52 weeks from baseline
Secondary	Change of the Behavioural Regulation in Exercise Questionaire (BREQ) score	Motivation	4, 12, 26 and 52 weeks from baseline
Secondary	Change of the Difficulties in Emotion Regulation (DERS) score	Emotion regulation	4, 12, 26 and 52 weeks from baseline
Secondary	Change in heart rate (beats per minute)	Heart rate variability	4, 12, 26 and 52 weeks from baseline
Secondary	Change of maximal oxygene extraction (VO2max)	Aerobic capacity	4, 12, 26 and 52 weeks from baseline
Secondary	Change of level of inflammatory markers in blood	Inflammation	4, 12, 26 and 52 weeks from baseline
Secondary	Change of body weight (kilograms)	Body weight change	4, 12, 26 and 52 weeks from baseline
Secondary	Change of hip- and waist circumference (centimetres)	Change of hip- and waist circumference	4, 12, 26 and 52 weeks from baseline
Secondary	Change of serum glucose (mmol/L)	Change of serum glucose	4, 12, 26 and 52 weeks from baseline
Secondary	Change of serum cholesterols (mmol/L)	Change of serum cholesterols	4, 12, 26 and 52 weeks from baseline
Secondary	Change of serum triglyceride (mmol/L)	Change of serum triglyceride (mmol/L)	4, 12, 26 and 52 weeks from baseline
Secondary	Change of gene expression	RNA	4, 12, 26 and 52 weeks from baseline
Secondary	Change of methylation of DNA	Epigenetic changes	4, 12, 26 and 52 weeks from baseline
Secondary	Change of the Young Mania Rating Scale (YMRS) score	Symptoms of mania	4, 12, 26 and 52 weeks from baseline