Not Yet RecruitingNot Applicable

Strategic Timing of Resistance Training to Guard Against Antipsychotic-Induced Metabolic Syndrome

Ireland40 participantsStarted 2026-02-01

Plain-language summary

This study is evaluating whether a supervised resistance training (strength training) programme is feasible to perform in a first-episode psychosis service. It is also evaluating if resistance training can prevent harmful weight gain and improve physical health in people who have recently been diagnosed with First-Episode Psychosis and are starting antipsychotic medication. Antipsychotic medications are essential for treating psychosis, but they frequently cause rapid weight gain and metabolic side effects (such as changes in blood sugar and cholesterol) within the first few months of treatment. Resistance training is a form of exercise that builds muscle and improves how the body uses energy. An excess of calories, which would otherwise lead to accumulation of fat (adipose tissue), can help build strength and increase muscle size when paired with resistance training. Participants in this study will be randomly assigned to one of two groups: Intervention Group: Participants will receive their standard medical care plus a 12-week resistance training programme. This involves attending two 60-minute exercise sessions per week, supervised by a qualified instructor. The sessions will include exercises using resistance bands, machine weights, and free weights tailored to the individual's ability. Control Group: Participants will receive standard medical care only for the first 12 weeks. The study uses a "crossover" design, which means that after the initial 12 weeks, the Control Group will be offered the same 12-week resistance training programme. The main goals of this study are to determine if it is feasible to run this type of exercise programme for this group of patients and to measure the effects of the training on body fat levels, muscle strength, and overall physical and mental health

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Aged between 18 and 65 years.
. Has the capacity to provide written informed consent.
. Has a clinical diagnosis of a First-Episode Psychosis (affective or non-affective) made within the past three months.
. Has had a cumulative lifetime exposure to antipsychotic medication for less than four weeks at the time of enrolment.
. Be prescribed an antipsychotic medication at the time of enrolment.
. Every effort will be made to include the migrant population, who have double the risk of developing psychosis compared to the general population. An interpreter service will be used during the consent stage to ensure fully informed consent is established.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in body fat percentage

Timeframe: Baseline, 12 weeks

Number of participants recruited

Timeframe: Baseline, 12 weeks, 24 weeks

Attendance by participants to intervention

Timeframe: Baseline, 12 weeks, 24 weeks

Trial details

NCT IDNCT07386483

SponsorUniversity College Dublin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-31

Contact for this trial

Brian W O'Mahony, MD

+353868820849 brian.omahony3@ucdconnect.ie

View on ClinicalTrials.gov More Psychosis trials