Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-09-27
2026-09-26
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard HIT
Standard 4 x 4 min HIT at treadmill. First 7 min warm-up, then 4 sessions with 4 min walking/running at 80-95% of maximal heart rate, with 3 min of active rest in between. Ending with 5 min of cooling down. Two sessions per week for 26 weeks.
High intensity training (HIT)
Please see information already included in the arm descriptions.
Short HIT
Short 1 x 4 min HIT at treadmill. Starting with 7 min warm-up walking/running, then 1 session with 4 min walking/running at 80-95% of maximal heart rate, ending with 5 min of cooling down. Two sessions per week for 26 weeks.
High intensity training (HIT)
Please see information already included in the arm descriptions.
Interventions
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High intensity training (HIT)
Please see information already included in the arm descriptions.
Eligibility Criteria
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Inclusion Criteria
* ICD-10 bipolar disorder (F3)
* Capacity to provide informed consent.
Exclusion Criteria
* Life threatening or terminal medical conditions
* Not able to carry out intervention or test procedures
* Current pregnancy
* Mothers less than 6 months post-partum.
16 Years
ALL
No
Sponsors
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Haukeland University Hospital
OTHER
Responsible Party
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Locations
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Haukeland University Hospital
Bergen, , Norway
Countries
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Central Contacts
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Facility Contacts
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Erik Johnsen, MD, PhD
Role: primary
Rune A Kroken, MD, PhD
Role: backup
Other Identifiers
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REK nr. 428096
Identifier Type: -
Identifier Source: org_study_id