PsychosisSTART GAAIMSNCT07386483
Strategic Timing of Resistance Training to Guard Against Antipsychotic-Induced Metabolic Syndrome
A study testing Resistance training programme in people with Psychosis, run by University College Dublin at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Resistance training programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- 1 Feb 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for inclusion, a participant must meet the following 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.
Who cannot join
- A participant will be excluded from the study if they meet any of the following criteria:
- 1a. A medical condition that, in the investigator's opinion, would prevent them from giving informed consent.
- 1b. 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).
- 2. 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.
- 3. Currently participating in another clinical trial of an investigational medicinal product or device.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site
St Vincent's University Hospital / University College Dublin
Dublin
About this study
Official title: Strategic Timing of Resistance Training to Guard Against Antipsychotic-Induced Metabolic Syndrome (START GAAIMS): A Feasibility Study for a Prospective, Two-Arm, Randomised Controlled Trial to Evaluate the Effects of a Resistance Training Intervention on Body Composition and Metabolic Health in People With First-Episode Psychosis
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.
Read more
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
- Being tested
- Resistance training programme
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance training programmeOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 12 weeks
Number of participants recruited
Feasibility will be determined by achieving the target of 40 participants over the 24-month recruitment period.
Measured: 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.
Measured: Baseline, 12 weeks, 24 weeks
Secondary outcomes (12)
Body Mass Index
Assessment of Body Mass Index (BMI, kg/m²) will be calculated by combining weight, measured with Tanita mc-780MA body composition analyser, and height, measured with a wall mounted height measurer.
Measured: Baseline, 12 weeks, 24 weeks
Weight
Measured with Tanita mc-780MA body composition analyser. Will be used in conjunction with height to estimate Body Mass Index
Measured: Baseline, 12 weeks, 24 weeks
Change in HDL
Assessment of fasting blood samples to evaluate High-Density Lipoprotein (HDL) cholesterol
Measured: Baseline, 12 weeks, 24 weeks
Change in Muscular Strength (Upper and Lower Body)
Maximal strength will be assessed using the One Repetition Maximum or Three Repitition Maximum test for the Chest Press, Row, and Leg Press exercises.
Measured: Baseline, 12 weeks, 24 weeks
Change in LDL
Assessment of fasting blood samples to evaluate Low-Density Lipoprotein (LDL) cholesterol
Measured: Baseline, 12 weeks, 24 weeks
Changes in fasting glucose
Assessment of fasting blood samples to evaluate Glucose
Measured: Baseline, 12 weeks, 24 weeks
Change in HbA1c
Assessment of blood samples to evaluate Glycated Haemoglobin (HbA1c), which measures average blood glucose levels over the past 2-3 months by checking sugar attached to red blood cells. It is used to diagnose prediabetes (42-47) mmol/mol and diabetes (48) mmol/mol.
Measured: Baseline, 12 weeks, 24 weeks
Change in functioning
Change in clinician-rated Global Assessment of Functioning (GAF) scale. On a scale of 1-100, where 100 represents superior functioning with no symptoms, and 1 represents persistent danger of severely hurting self/others or, inability to maintain minimal personal hygiene.
Measured: Baseline, 12 weeks, 24 weeks
Change in self-rated function
Change in scores of the patient-rated 5-level EQ-5D version (EQ-5D-5L). This assesses five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) across five levels of severity, providing a sensitive, validated tool for clinical and economic research.
Consists of the EQ-5D descriptive system (5-digit health state) and the EQ VAS (Visual Analogue Scale), which records self-rated health on a 0-100 scale.
Scoring: Results are used to create utility values (index scores) anchored at 0 (dead) and 1 (full health)
Measured: Baseline, 12 weeks, 24 weeks
Change in recovery scale scores
Change in score of the Questionnaire about the Process of Recovery, a 15-item self-administered tool used to measure personal recovery in individuals with mental health conditions, particularly psychosis. Items are rated on a 5-point Likert scale, ranging from 0 (strongly disagree) to 4 (strongly agree).
Higher total scores indicate a greater degree of personal recovery
Measured: Baseline, 12 weeks, 24 weeks
Change in psychiatric symptoms
Assessment of psychiatric symptoms using Brief Psychiatric Rating Scale (BPRS). Clinicians rate each symptom construct on a scale usually ranging from 1 (not present) to 7 (extremely severe), meaning a higher total score indicates greater psychopathology
Measured: Baseline, 12 weeks, 24 weeks
Height
Measured with a wall mounted height measurer. Note, height is not expected to change, but will be used in order to calculate Body Mass Index
Measured: Baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- St Vincent's University Hospital, Ireland
- Responsible party
- Sponsor
- Investigators
- Brian O'Donoghue, MD, PhD, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386483
- Sponsor's protocol ID
- START GAAIMS
- Other IDs
- ICAT-2022-001
- Acronym
- START GAAIMS
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised individual participant data (IPD) will be made available to researchers upon reasonable request following the publication of the main trial results. In accordance with FAIR data principles, the study data will be stored securely, and all data analysis will be performed in R, with the analysis code also made available to ensure reproducibility.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic Timing of Resistance Training to Guard Against Antipsychotic-Induced Metabolic Syndrome (START GAAIMS): A Feasibility Study for a Prospective, Two-Arm, Randomised Controlled Trial to Evaluate the Effects of a Resistance Training Intervention on Body Composition and Metabolic Health in People With First-Episode Psychosis
- ClinicalTrials.gov ID
- NCT07386483
- Acronym / sponsor ID
- START GAAIMS / START GAAIMS
- Conditions
- Psychosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- St Vincent's University Hospital, Ireland
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training programme + Treatment as usual | Experimental | Other: Resistance training programmeParticipants 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. |
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 1a. A medical condition that, in the investigator's opinion, would prevent them from giving informed consent.
- 1b. 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).
- 2. 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.
- 3. Currently participating in another clinical trial of an investigational medicinal product or device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance training programmeParticipants 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 | Other | Resistance training programme + Treatment as usual |
Primary outcome
Change in body fat percentage
Time frame: Baseline, 12 weeks
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
Number of participants recruited
Time frame: Baseline, 12 weeks, 24 weeks
Feasibility will be determined by achieving the target of 40 participants over the 24-month recruitment period.
Attendance by participants to intervention
Time frame: Baseline, 12 weeks, 24 weeks
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.
12 secondary outcomes
Body Mass Index
Time frame: Baseline, 12 weeks, 24 weeks
Weight
Time frame: Baseline, 12 weeks, 24 weeks
Change in HDL
Time frame: Baseline, 12 weeks, 24 weeks
Change in Muscular Strength (Upper and Lower Body)
Time frame: Baseline, 12 weeks, 24 weeks
Change in LDL
Time frame: Baseline, 12 weeks, 24 weeks
Changes in fasting glucose
Time frame: Baseline, 12 weeks, 24 weeks
Change in HbA1c
Time frame: Baseline, 12 weeks, 24 weeks
Change in functioning
Time frame: Baseline, 12 weeks, 24 weeks
Change in self-rated function
Time frame: Baseline, 12 weeks, 24 weeks
Change in recovery scale scores
Time frame: Baseline, 12 weeks, 24 weeks
Change in psychiatric symptoms
Time frame: Baseline, 12 weeks, 24 weeks
Height
Time frame: Baseline, 12 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Yes. Anonymised individual participant data (IPD) will be made available to researchers upon reasonable request following the publication of the main trial results. In accordance with FAIR data principles, the study data will be stored securely, and all data analysis will be performed in R, with the analysis code also made available to ensure reproducibility.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian O'Donoghue, MD, PhD principal investigator
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training programme in people with Psychosis, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian W O'Mahony, MD (+353868820849, brian.omahony3@ucdconnect.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body fat percentage (time frame: Baseline, 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.