Long-Term Exercise Training Therapy Versus Usual Care in Patients With Schizophrenia

NCT ID: NCT02743143

Last Updated: 2019-10-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-06-30

Brief Summary

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Patients with schizophrenia have disabling symptoms and cognitive deficits that limit motivation, drive, social- and occupational performance, quality of life and self-efficacy. Schizophrenia also leads to a high risk of dying from cardiovascular disease. Explanatory trials suggest that exercise improves cognitive functioning, symptoms, and quality of life, and reduces the risk of cardiovascular disease. However, due to this illness, the participation in regular exercise is challenging. In this study it will be tested if patients with schizophrenia can participate in long-term exercise therapy, and whether long-term supervised exercise therapy is more beneficial than today's usual care.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Exercise therapy

High aerobic intensity training and maximal strength training 2 times per week in 1 year at the Hospital's Exercise Training Clinic. Patients receive comprehensive support from Trondheim municipal administration to facilitate adherence.

Group Type EXPERIMENTAL

Exercise therapy

Intervention Type BEHAVIORAL

Follow-up care as usual

The usual care (UC) group will receive the usual physical activity offered by the primary health care system. UC includes the traditional physical activity advice from the Health Directorate. The UC group are invited to supervised exercise at the exercise training Clinic after 1 year.

Group Type ACTIVE_COMPARATOR

Follow-up care as usual

Intervention Type OTHER

Interventions

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Exercise therapy

Intervention Type BEHAVIORAL

Follow-up care as usual

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* International Classification of Diseases (ICD-10) schizophrenia, schizotypal or delusional disorders (F20 to F29)
* able to carry out long-term exercise.
* capable of giving informed consent.

Exclusion Criteria

* contra-indication for exercise training and testing according to the American College of Sports Medicine (ACSM) specifications (life threatening or terminal medical conditions; not able to carry out intervention or test procedures; current pregnancy; mothers less than 6 months post-partum).
* patients under admittance to an acute psychiatric ward.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trondheim Kommune

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gunnar Morken, PhD

Role: STUDY_DIRECTOR

St. Olavs University Hospital

Locations

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St. Olavs University Hospital, Division of Psychiatry, Department of Østmarka

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Brobakken MF, Nygard M, Guzey IC, Morken G, Reitan SK, Heggelund J, Wang E, Vedul-Kjelsaas E. Aerobic interval training in standard treatment of out-patients with schizophrenia: a randomized controlled trial. Acta Psychiatr Scand. 2019 Dec;140(6):498-507. doi: 10.1111/acps.13105. Epub 2019 Oct 16.

Reference Type RESULT
PMID: 31565796 (View on PubMed)

Other Identifiers

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2015/1611

Identifier Type: -

Identifier Source: org_study_id

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