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| Name | Class |
|---|---|
| Trondheim Kommune | OTHER |
| Norwegian University of Science and Technology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise therapy | Experimental | 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. |
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| Follow-up care as usual | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise therapy | Behavioral |
| ||
| Follow-up care as usual |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peak oxygen uptake. | Peak oxygen uptake after the training period subtracted Peak oxygen uptake at baseline. | Baseline, 12 weeks, 1 year, 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity. | Activity counts measured by Actigraph after the training period subtracted Actigraph measurements at baseline. | Baseline, 12 weeks, 1 year, 2 years. |
| Changes in walking economy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunnar Morken, PhD | St. Olavs Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Olavs University Hospital, Division of Psychiatry, Department of Østmarka | Trondheim | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31565796 | Result | 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. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D000359 | Aftercare |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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Walking economy (oxygen uptake at a standard workload) after the training period subtracted walking economy at baseline.
| Baseline, 12 weeks, 1 year, 2 years. |
| Real world functional behavior | Specific levels of functioning scale (SLOF). | Baseline, 1 year, 2 years. |
| Functional competence | University of California San Diego Performance-Based Skills Assessments (UPSA-Brief). | Baseline,1 year, 2 years. |
| Hospital stays and contact with health care providers. | Registrations from patient journals | Baseline, 1 year, 2 years. |
| Balance | Single leg stance. Measured in seconds. | Baseline, 12 weeks, 1 year, 2 years. |
| Sit-to-stand test | 30-second sit-to-stand test. Number of full stands in 30 seconds. | Baseline, 12 weeks, 1 year, 2 years. |
| Walking performance | 6-minute walk test. Performance measured in meters. | 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. | Baseline, 12 weeks, 1 year, 2 years. |
| Clinical symptoms. | Positive and Negative Syndrome Scale (PANSS). | Baseline, 1 year, 2 years. |
| Global functioning | Global Assessment of Functioning Scale (GAFs and GAFf) | Baseline, 1 year, 2 years. |
| Quality of life. | SF-36® Health Survey (SF-36) | Baseline, 12 weeks, 1 year, 2 years. |
| Quality-adjusted life year | EuroQol five dimensions questionnaire (EQ-5D) | Baseline, 12 weeks, 1 year, 2 years. |
| Morning fasting blood levels. | Baseline, 12 weeks, 1 year, 2 years. |
| Tobacco | Tobacco use measured by Fagerströms. | 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). | Baseline, 12 weeks, 1 year, 2 years. |
| Motivation | Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2). | Baseline, 12 weeks, 1 year, 2 years. |
| Readiness/confidence to change | Rulers (0-10 scale: readiness, importance, confidence). | Baseline, 12 weeks, 1 year, 2 years. |
| Client Satisfaction | Client Satisfaction Questionnaire (CSQ-8). | 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. | Baseline, 12 weeks, 1 year, 2 years. |
| Patient activation | Patient Activation Measure (PAM-13 GH) | Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years |
| Patient activation | Patient Activation Measure (PAM-13 MH) | Baseline, 1 week, 12 weeks, 6 months, 1 year, 2 years |
| D026741 |
| Physical Therapy Modalities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |