Value of Gym-based Exercise Training for Young Adults Receiving Antipsychotic Medication: A Pragmatic, Single-blinded, Multicenter Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 226
- Locations
- 4
- Primary Endpoint
- Personal recovery
Study Overview
Brief Summary
This is a multicentre, pragmatic, randomised controlled trial to estimate the effect of a 4-month gym-based exercise training program on 1) patient-rated personal recovery (primary outcome), 2) Health-related quality of life, behavioral and functional symptoms, and cardiometabolic risk factors (secondary outcomes) in young adults with psychotic disorders.
Four-hundred antipsychotic-treated young adults (between the age of 18 and 35), who are capable to undertake an exercise program (potentially with a friend or family member where possible) will be recruited from outpatient treatment units and mental health services. Participants will be randomised to treatment as usual or exercise at a 2:1 ratio in favor of exercise. Outcomes will be measured at baseline and at 4, 6 and 12 months after randomisation, by researchers masked to participant allocation.
Detailed Description
Background:
Antipsychotic medications are associated with development of metabolic side-effects. Patients with schizophrenia have a four-fold higher prevalence of metabolic syndrome, and a two-to-three-fold higher risk of cardiovascular diseases compared to the general population. These factors may contribute to the premature mortality of 15-20 years observed in people with schizophrenia. The increased morbidity and mortality in people with mental illness can be explained by several risk factors, including physical inactivity.
Evidence suggests that exercise can have beneficial effects on multiple cardiometabolic outcomes, and improve clinical symptoms, quality of life, global functioning, and reduce negative and depressive symptoms in people with schizophrenia. In general, greater effects are seen for higher doses of aerobic exercise and motivational theory-based interventions supervised by exercise professionals. However, because of strict inclusion criteria, the external validity of existing studies is limited, and effectiveness studies are urgently needed
Objectives:
The primary objective is to determine the effectiveness of participation in a four-month supervised, gym-based exercise program among people treated with antipsychotic medication compared to usual care on patient-rated recovery (primary outcome).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosed with a psychotic disorder (F20-F29 Schizophrenia, schizotypal and delusional disorders) or an affective disorder (F30-F39 Mood [affective] disorders)
- •able to read and speak Danish or English
Exclusion Criteria
- •advised from participating in exercise training by their treating doctor
Arms & Interventions
Vega Exercise Community
Participants will be offered one hour of tailored supervised, gym-based exercise training three times per week for a period of four months. In addition, participants are offered free-of-charge membership to the gym for six months and are invited to take part in training classes and use fitness equipment provided by the gym to regular members. The supervised program is tailored to meet the needs and requirements of this particular group of young adults and will include three weekly sessions of moderate-to-high intensity and mobility exercises.
Intervention: Supervised exercise (Behavioral)
Usual care
Participants will receive treatment as usual and be informed of the official physical activity guidelines as part of the information on group allocation. Moreover, they will be advised to continue their daily living, as they normally would do, not guiding them to other interventions neither preventing them to do so. In addition, participants in the usual care group will be given a subsidized membership including access to the exercise classes for four months after the 12 months follow up.
Outcomes
Primary Outcomes
Personal recovery
Time Frame: Baseline to four months
15-item Questionnaire about the Process of Recovery
Secondary Outcomes
- Cardiorespiratory fitness(Baseline to four, six and 12 months)
- Mental health(Baseline to four months)
- Positive and negative symptoms(Baseline to four, six and 12 months)
- Personal recovery(Baseline to six months and 12 months)
- Health-related quality of life(Baseline to four, six and 12 months)
- Affective symptoms(Baseline to four, six and 12 months)
- Physical Activity(Baseline to four, six and 12 months)
- Internalized Stigma(Baseline to four, six and 12 months)
- Use of substance (alcohol, cannabis, drugs)(Baseline to four, six and 12 months)
- Sleep(Baseline to four, six and 12 months)
- Loneliness(Baseline to four, six and 12 months)
- Abdominal circumference(Baseline to four, six and 12 months)
- Body weight(Baseline to four, six and 12 months)
- Total body fat(Baseline to four, six and 12 months)
- Blood pressure(Baseline to four, six and 12 months)
- Resting heart rate(Baseline to four, six and 12 months)
- High density lipoproteins (HDL)(Baseline to four, six and 12 months)
- Triglycerides(Baseline to four, six and 12 months)
- Glycosylated haemoglobin (HbA1c)(Baseline to four, six and 12 months)
- C-reactive protein (CRP)(Baseline to four, six and 12 months)
- Low density lipoproteins (LDL)(Baseline to four, six and 12 months)
- Skeletal muscle mass(Baseline to four, six and 12 months)
Investigators
Bolette Rafn
Postdoc
Rigshospitalet, Denmark