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

Psychosis Clinical Trial

— TREPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05719116
• Other study ID #: 2018-17695
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2023
• Source: Solli Distriktspsykiatriske Senter
• Contact: Kristine Sirevåg
• Phone: 004793645380
• Email: kristine.sirevag[@]solli.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Behavioral:
• Physical exercise
The physical exercise will be aerobic and strength training. The sessions will last app. 1 hour.

Locations

Country	Name	City	State
Norway	Solli DPS	Bergen	Nesttun

Sponsors (1)

Lead Sponsor	Collaborator
Solli Distriktspsykiatriske Senter

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	In depth interview	A semi structured interview for asking the participants about their experience with the intervention	After 16 weeks of intervention
Primary	Feasibility of the intervention program	How many participants completed the physical training intervention.	After 16 weeks of intervention
Secondary	Aerobic capasity: Ekblom Bak submaximal ergometer cycle test	Estimating Vo2max	At week 0 and 16
Secondary	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
Secondary	Strength: 1 RM test of bench press	Maximal test of strenght of upper body	At week 0 and 16
Secondary	Strenght: 1 RM test of squat	Maximal test of lower body musculature	At week 0 and 16
Secondary	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
Secondary	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
Secondary	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
Secondary	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