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

Sponsor
Solli Distriktspsykiatriske Senter (Other)
Overall Status
Recruiting
CT.gov ID
NCT05719116
Collaborator
(none)
20
1
1
25.3
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Physical exercise
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
As the main aim of the study is to investigate feasibility, no randmisation is done at this stage.As the main aim of the study is to investigate feasibility, no randmisation is done at this stage.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Combined Aerobic and Resistance Training Program for Adults With Psychotic Disorders
Actual Study Start Date :
Nov 23, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Physical exercise

Participants 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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility of the intervention program [After 16 weeks of intervention]

    How many participants completed the physical training intervention.

Secondary Outcome Measures

  1. Aerobic capasity: Ekblom Bak submaximal ergometer cycle test [At week 0 and 16]

    Estimating Vo2max

  2. Aerobic capasity: 4 x 4 interval for estimating VO2max [At week 0 and 16]

    Standarised 4x4 interval training for estimating VO2max with the smartphone app My Workout GO

  3. Strength: 1 RM test of bench press [At week 0 and 16]

    Maximal test of strenght of upper body

  4. Strenght: 1 RM test of squat [At week 0 and 16]

    Maximal test of lower body musculature

  5. Psychotic symptoms: The Positive and Negative Syndrome Scale [At week 0 and 16]

    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.

  6. Depression symptoms: The Calgary Depression Scale for Schizophrenia [At week 0 and 16]

    A measure of depressive symptoms. Each item is scored on a scale from 0-3 with a higher score indicating higher symptom level.

  7. Anxiety symptoms: GAD-7 [At week 0 and 16]

    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.

  8. Quality of life: SF-12 [At week 0 and 16]

    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...".

Other Outcome Measures

  1. In depth interview [After 16 weeks of intervention]

    A semi structured interview for asking the participants about their experience with the intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Solli DPS Bergen Nesttun Norway 5228

Sponsors and Collaborators

  • Solli Distriktspsykiatriske Senter

Investigators

  • Principal Investigator: Kristine Sirevåg, Solli DPS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Solli Distriktspsykiatriske Senter
ClinicalTrials.gov Identifier:
NCT05719116
Other Study ID Numbers:
  • 2018-17695
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023