Clinical trial NCT02743143: Long-Term Exercise Training Therapy Versus Usual Care in Patients With Schizophrenia
Official title: Effectiveness of 1 Year Supervised Exercise Training Versus Usual Care on Cardiovascular Health, Functional Skills and Physical Fitness in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Exercise therapy
Cardiovascular disease
Risk
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Trondheim Kommune
name: Norwegian University of Science and Technology
First posted: 2016-04-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in peak oxygen uptake.
timeFrame: Baseline, 12 weeks, 1 year, 2 years.
Secondary outcomes:
measure: Change in physical activity.
timeFrame: Baseline, 12 weeks, 1 year, 2 years.
measure: Changes in walking economy.
timeFrame: Baseline, 12 weeks, 1 year, 2 years.
measure: Real world functional behavior
timeFrame: Baseline, 1 year, 2 years.
measure: Functional competence
timeFrame: Baseline,1 year, 2 years.
measure: Hospital stays and contact with health care providers.
timeFrame: Baseline, 1 year, 2 years.
measure: Balance
timeFrame: Baseline, 12 weeks, 1 year, 2 years.
measure: Sit-to-stand test
timeFrame: Baseline, 12 weeks, 1 year, 2 years.
measure: Walking performance
timeFrame: Baseline, 12 weeks, 1 year, 2 years.
measure: Stair performance
timeFrame: Baseline, 12 weeks, 1 year, 2 years.
measure: Clinical symptoms.
timeFrame: Baseline, 1 year, 2 years.
measure: Global functioning
timeFrame: Baseline, 1 year, 2 years.
measure: Quality of life.
timeFrame: Baseline, 12 weeks, 1 year, 2 years.
measure: Quality-adjusted life year
timeFrame: Baseline, 12 weeks, 1 year, 2 years.
measure: Morning fasting blood levels.
timeFrame: Baseline, 12 weeks, 1 year, 2 years.
measure: Tobacco
timeFrame: Baseline, 12 weeks, 1 year, 2 years.
measure: Alcohol and substance abuse
timeFrame: Baseline, 12 weeks, 1 year, 2 years.
measure: Motivation
timeFrame: Baseline, 12 weeks, 1 year, 2 years.
measure: Readiness/confidence to change
timeFrame: Baseline, 12 weeks, 1 year, 2 years.
measure: Client Satisfaction
timeFrame: Baseline, 12 weeks, 1 year, 2 years.
measure: Changes in maximal strength.
timeFrame: Baseline, 12 weeks, 1 year, 2 years.
measure: Patient activation
timeFrame: Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years
measure: Patient activation
timeFrame: Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital, Division of Psychiatry, Department of Østmarka
Study officials:
affiliation: St. Olavs University Hospital
name: Gunnar Morken, PhD
role: STUDY_DIRECTOR
References:
citation: 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.