Exercise Therapy in Mental Disorders-study

NCT06313918 | Recruiting

• 1 other identifier: REK nr. 428096
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia and Related Disorders; Bipolar Disorder

Keywords

Exercise therapy; Effectiveness

Outcome Measures

Primary Outcomes (1)

• Adherence

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

  26 weeks

Secondary Outcomes (20)

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

  4, 12, 26 and 52 weeks from baseline

• Change of the Calgary Depression Scale in Schizophrenia score

  4, 12, 26 and 52 weeks from baseline

• Change of the Clinical Global Impression (CGI) score

  4, 12, 26 and 52 weeks from baseline

• Change of the Global Assessment of Funtioning (GAF) score

  4, 12, 26 and 52 weeks from baseline

• Change of quality of life (QOL10) score

  4, 12, 26 and 52 weeks from baseline

Study Arms (2)

Standard HIT

ACTIVE COMPARATOR

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)

Short HIT

EXPERIMENTAL

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)

Interventions

High intensity training (HIT) OTHER

Please see information already included in the arm descriptions.

Short HIT; Standard HIT

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, 5020, Norway

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Erik Johnsen, PhD

CONTACT

004792456225; erik.johnsen@helse-bergen.no

Rune A Kroken, PhD

CONTACT

004792095205; rune.andreas.kroken@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: March 15, 2024
• Study Start: September 27, 2023
• Primary Completion (Estimated): September 26, 2026
• Study Completion (Estimated): September 26, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)