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

NCT07386483 | Not Yet Recruiting DMC

• 2 other identifiers: START GAAIMSICAT-2022-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Psychosis

Outcome Measures

Primary Outcomes (3)

• Change in body fat percentage

  Body composition will be assessed using a Tanita mc-780MA body composition analyser. The outcome measure is the difference in the change in body fat percentage between the intervention and control groups

  Baseline, 12 weeks

• Number of participants recruited

  Feasibility will be determined by achieving the target of 40 participants over the 24-month recruitment period.

  Baseline, 12 weeks, 24 weeks

• Attendance by participants to intervention

  Feasibility will be measured by adherence to the intervention: Determined by the percentage of participants randomised to the intervention arm who complete at least 16 of the 24 supervised sessions (≥66% adherence). The intervention is considered deliverable if ≥66% of participants meet this threshold.

  Baseline, 12 weeks, 24 weeks

Secondary Outcomes (12)

• Body Mass Index

  Baseline, 12 weeks, 24 weeks

• Weight

  Baseline, 12 weeks, 24 weeks

• Change in HDL

  Baseline, 12 weeks, 24 weeks

• Change in Muscular Strength (Upper and Lower Body)

  Baseline, 12 weeks, 24 weeks

• Change in LDL

  Baseline, 12 weeks, 24 weeks

Study Arms (2)

Resistance training programme + Treatment as usual

EXPERIMENTAL

Participants will receive a 12-week, twice-weekly supervised resistance training programme, as well as their usual care from their community early intervention in psychosis team.

Other: Resistance training programme

Treatment as Usual

NO INTERVENTION

This arm will receive the standard care from their community early intervention in psychosis team. After 12 weeks, they will be offered the 12-week, twice weekly resistance training programme

Interventions

Resistance training programme OTHER

Participants will attend a 12-week supervised resistance training programme consisting of two 60-minute sessions per week. Each session includes a 5-10 minute aerobic warm-up, 45-50 minutes of resistance exercises, and a 5-minute cool-down. The programme is individualised and supervised by a qualified exercise practitioner. The intervention targets major muscle groups using 6-8 core exercises (e.g., chest press, lat pulldown, leg press, seated row, overhead press) performed in 3 sets of 6-12 repetitions. Training begins with resistance bands to establish technique (weeks 1-2) before progressing to machine and free weights. The principle of progressive overload is applied by increasing the weight once a participant can comfortably complete 3 sets of 10 repetitions in two consecutive sessions. Sessions are conducted in small groups to foster social support

Resistance training programme + Treatment as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• A participant will be excluded from the study if they meet any of the following criteria:
• a. A medical condition that, in the investigator's opinion, would prevent them from giving informed consent.
• b. A medical condition that, in the investigator's opinion, would prevent them from safely participating in an exercise programme (e.g., severe, unstable cardiovascular disease, significant musculoskeletal injury).
• \. Pregnant women will not be included, as hormonal changes would increase the risk of musculoskeletal injury (due to relaxin increasing laxity in ligaments and joints), maternal and foetal cardiovascular strain during the Valsalva manouevre, and additional confounders (due to pregnancy's effects on metabolism, energy levels, and physical capacity). Pregnancy is also associated with changes in body composition which affect the measurement of the primary outcome.
• \. Currently participating in another clinical trial of an investigational medicinal product or device.

Sponsors & Collaborators

• University College Dublin: lead
• St Vincent's University Hospital, Ireland: collaborator

Study Sites (1)

St Vincent's University Hospital / University College Dublin

Dublin, Ireland

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Brian O'Donoghue, MD, PhD

  University College Dublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian W O'Mahony, MD

CONTACT

+353868820849; brian.omahony3@ucdconnect.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: February 4, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: Protocol - Immediately Analytic code and CSR - Upon completion of study - anticipated April 2028
• Access Criteria: Principal Investigators of separate studies will be allowed to access the IPD upon reasonable request

Locations

IE (1)