Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06313918
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-10-20
Brief Title:
Exercise Therapy in Mental Disorders-study
Sponsor:
Haukeland University Hospital
Organization:
Haukeland University Hospital
Study Overview
Official Title:
Exercise Therapy in Mental Disorders-study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will compare standard high-intensity training with brief high-intensity training in people with schizophrenia-spectrum or bipolar disorder The overall aim is to determine which of the two is superior in a long-term perspective
Detailed Description:
Background Patients with severe mental disorders SMD including schizophrenia spectrum and bipolar disorders frequently experience suboptimal treatment effectiveness resulting in disabling residual symptoms and cognitive challenges and have elevated mortality risk amounting to 15-20 years of shortened life expectancy compared to the general population
Cardiovascular disease CVD is a major contributor in this regard Exercise in general improves cognitive functioning negative symptoms quality of life and reduces the risk of CVD High intensity training HIT has been shown to be feasible for persons with SMD but attrition and noncompliance are substantial and likely to limit the effectiveness of HIT A less strenuous HIT could increase adherence to the intervention which might compensate for a slightly lower efficacy compared to standard HIT Our study will compare standard 4x4-min HIT to a 4-min single-bout HIT session as well as explore exercise effects on basic processes in the body Methods Patients with schizophrenia spectrum and bipolar disorders are eligible for participation and those included will be randomized to 26 weeks of either 1 Standard 4 x 4 min HIT at treadmill or 2 Short 1 x 4 min HIT at treadmill To reduce dropout the intervention will usually be delivered in group format and conducted under the supervision of a physical therapist in collaboration with a postdoctor The research group has a stable staff with research nurses biostatisticians and researchers that will secure the dayto- day conductance of the project including psychometric assessments drawing of and biobanking of blood as well as data collection and storing Measures Mental and cognitive symptoms quality of life motivation Peak oxygen uptake V
Cardiovascular disease CVD is a major contributor in this regard Exercise in general improves cognitive functioning negative symptoms quality of life and reduces the risk of CVD High intensity training HIT has been shown to be feasible for persons with SMD but attrition and noncompliance are substantial and likely to limit the effectiveness of HIT A less strenuous HIT could increase adherence to the intervention which might compensate for a slightly lower efficacy compared to standard HIT Our study will compare standard 4x4-min HIT to a 4-min single-bout HIT session as well as explore exercise effects on basic processes in the body Methods Patients with schizophrenia spectrum and bipolar disorders are eligible for participation and those included will be randomized to 26 weeks of either 1 Standard 4 x 4 min HIT at treadmill or 2 Short 1 x 4 min HIT at treadmill To reduce dropout the intervention will usually be delivered in group format and conducted under the supervision of a physical therapist in collaboration with a postdoctor The research group has a stable staff with research nurses biostatisticians and researchers that will secure the dayto- day conductance of the project including psychometric assessments drawing of and biobanking of blood as well as data collection and storing Measures Mental and cognitive symptoms quality of life motivation Peak oxygen uptake V
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None