Value of Gym-based Exercise Training for Young Adults Receiving Antipsychotic Medication: The Vega Trial

Psychosis Clinical Trial

— Vega  

Official title:

Value of Gym-based Exercise Training for Young Adults Receiving Antipsychotic Medication: A Pragmatic, Single-blinded, Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05461885
• Other study ID #: Vega Trial
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2022
• Est. completion date: October 2025

Study information

• Verified date: January 2024
• Source: Rigshospitalet, Denmark
• Contact: Bolette Skjødt Rafn, PhD
• Phone: 22913873
• Email: bolette.skjoedt.rafn[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Secondary objectives are to examine if the gym-based exercise program compared to usual care improves the following:

1. Mental health

2. Health-related quality of life

3. Behavioral and functional symptoms

4. Metabolic health

As tertiary objectives, we will investigate if:

1. Prolongation of subsidized gym membership in addition to motivational text messages (extended support) will be superior to subsidized gym membership alone (minimal support), and to treatment as usual in relation to post-intervention adoption of physical activity.

2. The exercise program impacts the quality of life and physical and mental health of the participants' primary relative.

3. Participation in the gym-based program is associated with a reduction in the participants' use of mental health care services.

4. The exercise program is cost-effective.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Affective Disorder
• Mood Disorders
• Psychosis

Intervention

Behavioral:
• Supervised exercise
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.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Mental Health Centre Copenhagen	Copenhagen
Denmark	Mental Health Centre Glostrup	Glostrup

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aalborg University Hospital, Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Use of the subsidized membership	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)	four to six months
Other	Extended vs. minimal support for physical activity	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).	four to six months
Other	Quality of life of primary relatives to participants	To explore the impact of the Vega Exercise Community on the quality of life measured by SF-12 of the participants' primary relative	Baseline to four, six and 12 months
Other	Sleep of primary relatives to participants	To explore the impact of the Vega Exercise Community on sleep (measured by B-PSQI) of the participants' primary relative	Baseline to four, six and 12 months
Other	Mental health of primary relatives to participants	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	Baseline to four, six and 12 months
Other	Physical activity of primary relatives to participants	To explore the impact of the Vega Exercise Community on physical activity (measured by IPAQ-SF) of the participants' primary relative	Baseline to four, six and 12 months
Other	Utilization of mental health care services	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	24 months and 60 months
Other	Cost of the Vega Exercise Community	To explore the intervention cost i.e., education of instructors and delivery of exercise classes	Baseline to four, six and 12 months
Other	Cost-effectiveness of the Vega Exercise Community	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)	Baseline to four, six and 12 months
Primary	Personal recovery	15-item Questionnaire about the Process of Recovery	Baseline to four months
Secondary	Personal recovery	15-item Questionnaire about the Process of Recovery	Baseline to six months and 12 months
Secondary	Mental health	Mental Component Summary from the Short-Form 12 (SF-12) Health survey	Baseline to four months
Secondary	Health-related quality of life	Short-Form 12 (SF-12) Health survey	Baseline to four, six and 12 months
Secondary	Affective symptoms	Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional distress	Baseline to four, six and 12 months
Secondary	Physical Activity	International Physical Activity Questionnaire short form (IPAQ-SF)	Baseline to four, six and 12 months
Secondary	Internalized Stigma	Internalized Stigma of Mental Illness Inventory (ISMI-9) short form	Baseline to four, six and 12 months
Secondary	Use of substance (alcohol, cannabis, drugs)	Measured by self-developed items with responses for each substance: "never used", "use less than once a month", "regular use", "harmful use"	Baseline to four, six and 12 months
Secondary	Sleep	Brief Pittsburgh Sleep Quality Index (B-PSQI)	Baseline to four, six and 12 months
Secondary	Positive and negative symptoms	Colorado Symptom Index (MCSI)	Baseline to four, six and 12 months
Secondary	Loneliness	Measured by a single item on a Likert scale of 4 levels: "During the past 12 months, have you felt lonely?"	Baseline to four, six and 12 months
Secondary	Abdominal circumference	Measured with tape measure	Baseline to four, six and 12 months
Secondary	Body weight	Measured on a scale	Baseline to four, six and 12 months
Secondary	Skeletal muscle mass	Measured by bioimpedance	Baseline to four, six and 12 months
Secondary	Total body fat	Measured by bioimpedance	Baseline to four, six and 12 months
Secondary	Cardiorespiratory fitness	measured with the modified Ekblom-Bak submaximal cycle ergometer test	Baseline to four, six and 12 months
Secondary	Blood pressure	measured by a digital blood pressure monitor	Baseline to four, six and 12 months
Secondary	Resting heart rate	measured by a heart rate monitor	Baseline to four, six and 12 months
Secondary	High density lipoproteins (HDL)	Taken from routine blood tests (mmol/l)	Baseline to four, six and 12 months
Secondary	Low density lipoproteins (LDL)	Taken from routine blood tests (mmol/l)	Baseline to four, six and 12 months
Secondary	Triglycerides	Taken from routine blood tests (mmol/l)	Baseline to four, six and 12 months
Secondary	Glycosylated haemoglobin (HbA1c)	Taken from routine blood tests (mmol/l)	Baseline to four, six and 12 months
Secondary	C-reactive protein (CRP)	Taken from routine blood tests (mg/L)	Baseline to four, six and 12 months