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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Psychosis

Intervention / Treatment
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* Behavioral: Physical exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 
| 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 | 
| 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 |