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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Psychosis
• Intervention / Treatment: Behavioral: Physical exercise

Detailed Description

The aim of this study is to investigate the feasibility of a 16 week physical exercise intervention combining strenght and aerobic training in group for patients with psychotic disorders. In addition, the feasibility of the test protocol and participants subjective experience with the intervention will be investigated.

Research shows positive effects of physical exercise for patients with psychotic disorders regarding maximal aerob training, maximal muscle strength, physical, cognitive and social functioning, and symptom levels. Effects and the degree of feasibility of physical exercise for patients with psychotic disorders are amplified by regarding their preferences and needs, and if they experience support and guidance during the intervention. Earlier studies have focused mostly on either strength og endurance training, or combined interventions of moderate intensity. We now want to investigate the feasibility of an invidually adjusted combined program of high intensity.

After the intervention, participants will be interviewed about their experience with participating.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Nesttun
    • Bergen, Nesttun, Norway, 5228
      • Solli DPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Participants with psychotic disorder:

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical exercise for participants with psychotic disorder; Participants with a psychotic disorder will exercise in a group supervised by a physiotherapist for 16 weeks, three times a week.	Behavioral: Physical exercise; The physical exercise will be aerobic and strength training. The sessions will last app. 1 hour.
Active Comparator: Physical exercise for participants with psychiatric disorder, but not psychotic disorder; Participants with a psychiatric disorder will exercise in a group supervised by a physiotherapist for 16 weeks, three times a week.	Behavioral: Physical exercise; The physical exercise will be aerobic and strength training. The sessions will last app. 1 hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the intervention program	How many participants completed the physical training intervention.	After 16 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aerobic capasity: Ekblom Bak submaximal ergometer cycle test	Estimating Vo2max	At week 0 and 16
Aerobic capasity: 4 x 4 interval for estimating VO2max	Standarised 4x4 interval training for estimating VO2max with the smartphone app My Workout GO	At week 0 and 16
Strength: 1 RM test of bench press	Maximal test of strenght of upper body	At week 0 and 16
Strenght: 1 RM test of squat	Maximal test of lower body musculature	At week 0 and 16
Depression symptoms: The Calgary Depression Scale for Schizophrenia	A measure of depressive symptoms. Each item is scored on a scale from 0-3 with a higher score indicating higher symptom level.	At week 0 and 16
Anxiety symptoms: GAD-7	A measure of anxiety symptoms. This is a 7-item self-report questionnaire where participants rate on a scale from 0 (not at all sure) to 3 (nearly every day). A higher score indicates greater symptom severity.	At week 0 and 16
Quality of life: SF-12	A measure of health related quality of life. The items is scored after variying categories such as "yes" and "no", and "How much time during the past 4 weeks...".	At week 0 and 16
Psychotic symptoms: The Positive and Negative Syndrome Scale	For the participants with psychotic disorders only. A measure of positive and negative psychotic symptoms. Each item is scored on a scale from 1-7 with a higher score indicating higher symptom level.	At week 0 and 16

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
In depth interview	A semi structured interview for asking the participants about their experience with the intervention	After 16 weeks of intervention

Collaborators and Investigators

• Sponsor: Solli Distriktspsykiatriske Senter
• Investigators: Principal Investigator: Kristine Sirevåg, Solli DPS

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Psychotic Disorders; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 2018-17695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to publish our results in peer-reviewed journals.
• IPD Sharing Time Frame: We plan to publish the study protocol. The statistical analysis plan will be available in published articles.
• IPD Sharing Access Criteria: After data collection has been completed, data can be available upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No