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Clinical Trials/NCT02743143
NCT02743143
Completed
Not Applicable

Effectiveness of 1 Year Supervised Exercise Training Versus Usual Care on Cardiovascular Health, Functional Skills and Physical Fitness in Patients With Schizophrenia

St. Olavs Hospital1 site in 1 country48 target enrollmentDecember 2015
ConditionsSchizophrenia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
St. Olavs Hospital
Enrollment
48
Locations
1
Primary Endpoint
Change in peak oxygen uptake.
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
June 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Change in peak oxygen uptake.

Time Frame: Baseline, 12 weeks, 1 year, 2 years.

Peak oxygen uptake after the training period subtracted Peak oxygen uptake at baseline.

Secondary Outcomes

  • Quality-adjusted life year(Baseline, 12 weeks, 1 year, 2 years.)
  • Hospital stays and contact with health care providers.(Baseline, 1 year, 2 years.)
  • Balance(Baseline, 12 weeks, 1 year, 2 years.)
  • Stair performance(Baseline, 12 weeks, 1 year, 2 years.)
  • Alcohol and substance abuse(Baseline, 12 weeks, 1 year, 2 years.)
  • Real world functional behavior(Baseline, 1 year, 2 years.)
  • Change in physical activity.(Baseline, 12 weeks, 1 year, 2 years.)
  • Clinical symptoms.(Baseline, 1 year, 2 years.)
  • Client Satisfaction(Baseline, 12 weeks, 1 year, 2 years.)
  • Sit-to-stand test(Baseline, 12 weeks, 1 year, 2 years.)
  • Walking performance(Baseline, 12 weeks, 1 year, 2 years.)
  • Morning fasting blood levels.(Baseline, 12 weeks, 1 year, 2 years.)
  • Tobacco(Baseline, 12 weeks, 1 year, 2 years.)
  • Motivation(Baseline, 12 weeks, 1 year, 2 years.)
  • Patient activation(Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years)
  • Changes in walking economy.(Baseline, 12 weeks, 1 year, 2 years.)
  • Functional competence(Baseline,1 year, 2 years.)
  • Global functioning(Baseline, 1 year, 2 years.)
  • Quality of life.(Baseline, 12 weeks, 1 year, 2 years.)
  • Changes in maximal strength.(Baseline, 12 weeks, 1 year, 2 years.)
  • Readiness/confidence to change(Baseline, 12 weeks, 1 year, 2 years.)

Study Sites (1)

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