Clinical trial NCT05719116: A Combined Aerobic and Resistance Training Program for Adults With Psychotic Disorders
Official title: A Combined Aerobic and Resistance Training Program for Adults With Psychotic Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Lead sponsor: Solli Distriktspsykiatriske Senter
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the intervention program
timeFrame: After 16 weeks of intervention
Secondary outcomes:
measure: Aerobic capasity: Ekblom Bak submaximal ergometer cycle test
timeFrame: At week 0 and 16
measure: Aerobic capasity: 4 x 4 interval for estimating VO2max
timeFrame: At week 0 and 16
measure: Strength: 1 RM test of bench press
timeFrame: At week 0 and 16
measure: Strenght: 1 RM test of squat
timeFrame: At week 0 and 16
measure: Psychotic symptoms: The Positive and Negative Syndrome Scale
timeFrame: At week 0 and 16
measure: Depression symptoms: The Calgary Depression Scale for Schizophrenia
timeFrame: At week 0 and 16
measure: Anxiety symptoms: GAD-7
timeFrame: At week 0 and 16
measure: Quality of life: SF-12
timeFrame: At week 0 and 16
Other outcomes:
measure: In depth interview
timeFrame: After 16 weeks of intervention
Locations:
city: Bergen
country: Norway
facility: Solli DPS
state: Nesttun
Study officials:
affiliation: Solli DPS
name: Kristine Sirevåg
role: PRINCIPAL_INVESTIGATOR
References: