NCT Number: NCT05461885
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.
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Notify Me18 year–35 year
All sexes
Interventional
Not applicable
Aalborg University Hospital, Aalborg, Denmark
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).
Secondary objectives are to examine if the gym-based exercise program compared to usual care improves the following:
As tertiary objectives, we will investigate if:
Design:
This is a multi-center, pragmatic, randomized (1:2) superiority trial to compare a 4-month, supervised, gym-based exercise training program to usual care. The pragmatic nature of the trial entails that it is designed to evaluate the effectiveness of interventions in real-life routine practice conditions.
In order to explore different ways to support sustainment (i.e., post-intervention adherence/adoption of physical activity), and to guide strategies to facilitate adherence, we will do "a study within a trial" (SWAT). Hence participants randomized to the intervention at baseline, will be randomized (allocation ratio 1:1) after four months to minimal vs. extended support with regards to sustainment of physical activity.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The exercise sessions start with warm-up exercises, followed by 10-20 minutes resistance training (Part A), 10-20 minutes High Intensity Functional Training (HIFT) (Part B) and cool down. Instructors are allowed to make local adjustments as the delivery of the intervention is considered pragmatic. The participants can either perform the exercise together as one group, in pairs or one-by-one depending on individual needs and requests.
Time frame: Baseline to four months
15-item Questionnaire about the Process of Recovery
Time frame: Baseline to six months and 12 months
15-item Questionnaire about the Process of Recovery
Time frame: Baseline to four months
Mental Component Summary from the Short-Form 12 (SF-12) Health survey
Time frame: Baseline to four, six and 12 months
Short-Form 12 (SF-12) Health survey
Time frame: Baseline to four, six and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional distress
Time frame: Baseline to four, six and 12 months
International Physical Activity Questionnaire short form (IPAQ-SF)
Time frame: Baseline to four, six and 12 months
Internalized Stigma of Mental Illness Inventory (ISMI-9) short form
Time frame: Baseline to four, six and 12 months
Measured by self-developed items with responses for each substance: "never used", "use less than once a month", "regular use", "harmful use"
Time frame: Baseline to four, six and 12 months
Brief Pittsburgh Sleep Quality Index (B-PSQI)
Time frame: Baseline to four, six and 12 months
Colorado Symptom Index (MCSI)
Time frame: Baseline to four, six and 12 months
Measured by a single item on a Likert scale of 4 levels: "During the past 12 months, have you felt lonely?"
Time frame: Baseline to four, six and 12 months
Measured with tape measure
Time frame: Baseline to four, six and 12 months
Measured on a scale
Time frame: Baseline to four, six and 12 months
Measured by bioimpedance
Time frame: Baseline to four, six and 12 months
Measured by bioimpedance
Time frame: Baseline to four, six and 12 months
measured with the modified Ekblom-Bak submaximal cycle ergometer test
Time frame: Baseline to four, six and 12 months
measured by a digital blood pressure monitor
Time frame: Baseline to four, six and 12 months
measured by a heart rate monitor
Time frame: Baseline to four, six and 12 months
Taken from routine blood tests (mmol/l)
Time frame: Baseline to four, six and 12 months
Taken from routine blood tests (mmol/l)
Time frame: Baseline to four, six and 12 months
Taken from routine blood tests (mmol/l)
Time frame: Baseline to four, six and 12 months
Taken from routine blood tests (mmol/l)
Time frame: Baseline to four, six and 12 months
Taken from routine blood tests (mg/L)
Time frame: four to six months
To explore if prolongation of subsidized gym membership in addition to motivational text messages (extended support) is superior to subsidized gym membership alone (minimal support), and to treatment as usual in relation to post-intervention adoption of physical activity measured by use of the subsidized membership (intervention group only)
Time frame: four to six months
To explore if prolongation of subsidized gym membership in addition to motivational text messages (extended support) is superior to subsidized gym membership alone (minimal support), and to treatment as usual in relation to post-intervention adoption of physical activity measured by the IPAQ-SF (both groups).
Time frame: Baseline to four, six and 12 months
To explore the impact of the Vega Exercise Community on the quality of life measured by SF-12 of the participants' primary relative
Time frame: Baseline to four, six and 12 months
To explore the impact of the Vega Exercise Community on sleep (measured by B-PSQI) of the participants' primary relative
Time frame: Baseline to four, six and 12 months
To explore the impact of the Vega Exercise Community on mental health (measured by PROMIS Emotional Distress-Depression - Short Form 4a) of the participants' primary relative
Time frame: Baseline to four, six and 12 months
To explore the impact of the Vega Exercise Community on physical activity (measured by IPAQ-SF) of the participants' primary relative
Time frame: 24 months and 60 months
To explore differences between groups of participants' long-term use of mental health care services, specifically number of inpatient and outpatient mental health contacts, including mental health emergency departments obtained from medical records
Time frame: Baseline to four, six and 12 months
To explore the intervention cost i.e., education of instructors and delivery of exercise classes
Time frame: Baseline to four, six and 12 months
To explore the cost-effectiveness by comparing the cost and health-related quality of life, which will be measured by the EuroQol-5 Domain (EQ-5D)
Rigshospitalet, Denmark
Other
Value of Gym-based Exercise Training for Young Adults Receiving Antipsychotic Medication: A Pragmatic, Single-blinded, Multicenter Randomized Controlled Trial
Acronym: Vega
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