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

Primary Purpose

Psychosis

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Physical exercise
Sponsored by
Solli Distriktspsykiatriske Senter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Solli DPSRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical exercise

Arm Description

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

Outcomes

Primary Outcome Measures

Feasibility of the intervention program
How many participants completed the physical training intervention.

Secondary Outcome Measures

Aerobic capasity: Ekblom Bak submaximal ergometer cycle test
Estimating Vo2max
Aerobic capasity: 4 x 4 interval for estimating VO2max
Standarised 4x4 interval training for estimating VO2max with the smartphone app My Workout GO
Strength: 1 RM test of bench press
Maximal test of strenght of upper body
Strenght: 1 RM test of squat
Maximal test of lower body musculature
Psychotic symptoms: The Positive and Negative Syndrome Scale
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.
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.
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.
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...".

Full Information

First Posted
November 23, 2022
Last Updated
January 31, 2023
Sponsor
Solli Distriktspsykiatriske Senter
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1. Study Identification

Unique Protocol Identification Number
NCT05719116
Brief Title
A Combined Aerobic and Resistance Training Program for Adults With Psychotic Disorders
Acronym
TREPP
Official Title
A Combined Aerobic and Resistance Training Program for Adults With Psychotic Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Solli Distriktspsykiatriske Senter

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
As the main aim of the study is to investigate feasibility, no randmisation is done at this stage.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical exercise
Arm Type
Experimental
Arm Description
Participants will exercise in a group supervised by a physiotherapist for 16 weeks, three times a week.
Intervention Type
Behavioral
Intervention Name(s)
Physical exercise
Intervention Description
The physical exercise will be aerobic and strength training. The sessions will last app. 1 hour.
Primary Outcome Measure Information:
Title
Feasibility of the intervention program
Description
How many participants completed the physical training intervention.
Time Frame
After 16 weeks of intervention
Secondary Outcome Measure Information:
Title
Aerobic capasity: Ekblom Bak submaximal ergometer cycle test
Description
Estimating Vo2max
Time Frame
At week 0 and 16
Title
Aerobic capasity: 4 x 4 interval for estimating VO2max
Description
Standarised 4x4 interval training for estimating VO2max with the smartphone app My Workout GO
Time Frame
At week 0 and 16
Title
Strength: 1 RM test of bench press
Description
Maximal test of strenght of upper body
Time Frame
At week 0 and 16
Title
Strenght: 1 RM test of squat
Description
Maximal test of lower body musculature
Time Frame
At week 0 and 16
Title
Psychotic symptoms: The Positive and Negative Syndrome Scale
Description
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.
Time Frame
At week 0 and 16
Title
Depression symptoms: The Calgary Depression Scale for Schizophrenia
Description
A measure of depressive symptoms. Each item is scored on a scale from 0-3 with a higher score indicating higher symptom level.
Time Frame
At week 0 and 16
Title
Anxiety symptoms: GAD-7
Description
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.
Time Frame
At week 0 and 16
Title
Quality of life: SF-12
Description
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...".
Time Frame
At week 0 and 16
Other Pre-specified Outcome Measures:
Title
In depth interview
Description
A semi structured interview for asking the participants about their experience with the intervention
Time Frame
After 16 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristine Sirevåg
Phone
004793645380
Email
kristine.sirevag@solli.no
First Name & Middle Initial & Last Name or Official Title & Degree
Trygve Endal
Phone
004755618227
Email
trygve.bruun.endal@solli.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine Sirevåg
Organizational Affiliation
Solli DPS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Solli DPS
City
Bergen
State/Province
Nesttun
ZIP/Postal Code
5228
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristine Sirevåg, PsyD
Phone
004755618315
Email
kristine.sirevag@solli.no
First Name & Middle Initial & Last Name & Degree
Trygve Endal
Phone
004755618227
Email
trygve.bruun.endal@solli.no
First Name & Middle Initial & Last Name & Degree
Kristine Sirevåg, PsyD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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