A Combined Aerobic and Resistance Training Program for Adults With Psychotic Disorders

NCT05719116 | Active Not Recruiting

• 1 other identifier: 2018-17695
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a feasibility study of a combined high intensity aerobic and strenght exercise program for persons with psychotic disorders. The feasibility of the protocol will be investigated, in addition to the participants subjective experience with the participation.

Conditions

Psychosis

Outcome Measures

Primary Outcomes (1)

• Feasibility of the intervention program

  How many participants completed the physical training intervention.

  After 16 weeks of intervention

Secondary Outcomes (8)

• Aerobic capasity: Ekblom Bak submaximal ergometer cycle test

  At week 0 and 16

• Aerobic capasity: 4 x 4 interval for estimating VO2max

  At week 0 and 16

• Strength: 1 RM test of bench press

  At week 0 and 16

• Strenght: 1 RM test of squat

  At week 0 and 16

• Psychotic symptoms: The Positive and Negative Syndrome Scale

  At week 0 and 16

Other Outcomes (1)

• In depth interview

  After 16 weeks of intervention

Study Arms (2)

Physical exercise for participants with psychotic disorder

EXPERIMENTAL

Participants with a psychotic disorder will exercise in a group supervised by a physiotherapist for 16 weeks, three times a week.

Behavioral: Physical exercise

Physical exercise for participants with psychiatric disorder, but not psychotic disorder

ACTIVE COMPARATOR

Participants with a psychiatric disorder will exercise in a group supervised by a physiotherapist for 16 weeks, three times a week.

Behavioral: Physical exercise

Interventions

Physical exercise BEHAVIORAL

The physical exercise will be aerobic and strength training. The sessions will last app. 1 hour.

Physical exercise for participants with psychiatric disorder, but not psychotic disorder; Physical exercise for participants with psychotic disorder

Eligibility Criteria

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

You may qualify if:

• Signed informed consent
• Diagnosed with psychotic disorder
• Physically able to participate in physical exercise
• Is a patient at Solli DPS
• Motivated for participating in physical exercise

You may not qualify if:

• Physical conditions precluding the participant from the physical testing/training
• Mental state that hinders participation, such as ongoing suicidality, substance abuse or brain organic disorder
• Participants with psychiatric disorder, but no psychotic disorder:
• Signed informed consent
• Diagnosed with psychiatric disorder, but not a psychotic disorder
• Physically able to participate in physical exercise
• Is a patient at Solli DPS
• Motivated for participating in physical exercise
• Physical conditions precluding the participant from the physical testing/training
• Mental state that hinders participation, such as ongoing suicidality, substance abuse or brain organic disorder

Sponsors & Collaborators

• Solli Distriktspsykiatriske Senter: lead

Study Sites (1)

Solli DPS

Bergen, Nesttun, 5228, Norway

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kristine Sirevåg

  Solli DPS

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: As the main aim of the study is to investigate feasibility, no randomisation is done at this stage. The participants with psychotic disorder will be compared with participants with a psychiatric disorder (but no psychotic disorder).

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: February 8, 2023
• Study Start: November 23, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: We plan to publish the study protocol. The statistical analysis plan will be available in published articles.
• Access Criteria: After data collection has been completed, data can be available upon reasonable request.

Locations

NO (1)