Clinical trial NCT06313918: Exercise Therapy in Mental Disorders-study
Official title: Exercise Therapy in Mental Disorders-study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia and Related Disorders
Bipolar Disorder
Keywords: Exercise therapy
Effectiveness
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence
timeFrame: 26 weeks
Secondary outcomes:
measure: Change of the Simplified Negative and Positive Symptoms Interview (SNAPSI) score
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of the Calgary Depression Scale in Schizophrenia score
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of the Clinical Global Impression (CGI) score
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of the Global Assessment of Funtioning (GAF) score
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of quality of life (QOL10) score
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of the International Physical Activity Questionaire (IPAQ) score
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of the Brief Assessment of Cognition in Schizophrenia (BACS) score
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of the Behavioural Regulation in Exercise Questionaire (BREQ) score
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of the Difficulties in Emotion Regulation (DERS) score
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change in heart rate (beats per minute)
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of maximal oxygene extraction (VO2max)
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of level of inflammatory markers in blood
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of body weight (kilograms)
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of hip- and waist circumference (centimetres)
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of serum glucose (mmol/L)
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of serum cholesterols (mmol/L)
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of serum triglyceride (mmol/L)
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of gene expression
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of methylation of DNA
timeFrame: 4, 12, 26 and 52 weeks from baseline
measure: Change of the Young Mania Rating Scale (YMRS) score
timeFrame: 4, 12, 26 and 52 weeks from baseline
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
References: