An interventional study of Exercise therapy and Follow-up care as usual in Schizophrenia, sponsored by St. Olavs Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-03.
Sponsored by St. Olavs Hospital · Not applicable, Interventional, and Prevention
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 48 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →St. Olavs Hospital is the lead sponsor of 165 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Exercise therapy
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.
Other: Follow-up care as usual
Change in peak oxygen uptake.
Peak oxygen uptake after the training period subtracted Peak oxygen uptake at baseline.
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Change in physical activity.
Activity counts measured by Actigraph after the training period subtracted Actigraph measurements at baseline.
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Changes in walking economy.
Walking economy (oxygen uptake at a standard workload) after the training period subtracted walking economy at baseline.
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Real world functional behavior
Specific levels of functioning scale (SLOF).
Time frame: Baseline, 1 year, 2 years.
Functional competence
University of California San Diego Performance-Based Skills Assessments (UPSA-Brief).
Time frame: Baseline,1 year, 2 years.
Hospital stays and contact with health care providers.
Registrations from patient journals
Time frame: Baseline, 1 year, 2 years.
Balance
Single leg stance. Measured in seconds.
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Sit-to-stand test
30-second sit-to-stand test. Number of full stands in 30 seconds.
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Walking performance
6-minute walk test. Performance measured in meters.
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Stair performance
Stair test. Participants are instructed to ascend and descend 18 steps 3 consecutive times. Performance measured in seconds.
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Clinical symptoms.
Positive and Negative Syndrome Scale (PANSS).
Time frame: Baseline, 1 year, 2 years.
Global functioning
Global Assessment of Functioning Scale (GAFs and GAFf)
Time frame: Baseline, 1 year, 2 years.
Quality of life.
SF-36® Health Survey (SF-36)
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Quality-adjusted life year
EuroQol five dimensions questionnaire (EQ-5D)
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Morning fasting blood levels.
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Tobacco
Tobacco use measured by Fagerströms.
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Alcohol and substance abuse
Substance abuse are measured by the Alcohol and Drug Use Disorder Identification test (AUDIT and DUDIT).
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Motivation
Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2).
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Readiness/confidence to change
Rulers (0-10 scale: readiness, importance, confidence).
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Client Satisfaction
Client Satisfaction Questionnaire (CSQ-8).
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Changes in maximal strength.
Maximal strength (measures as 1 repetition maximum (1RM)) after the training period subtracted 1RM at baseline.
Time frame: Baseline, 12 weeks, 1 year, 2 years.
Patient activation
Patient Activation Measure (PAM-13 GH)
Time frame: Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years
Patient activation
Patient Activation Measure (PAM-13 MH)
Time frame: Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
St. Olavs Hospital