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

ConditionPsychosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity College Dublin

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Resistance training programme

    Other intervention

    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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Resistance training programme + Treatment as usualExperimental treatment 1 intervention
Group B: Treatment as UsualNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, 12 weeks
2

Number of participants recruited

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

Time frame
Baseline, 12 weeks, 24 weeks
3

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.

Time frame
Baseline, 12 weeks, 24 weeks

Secondary outcomes

1

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.

Time frame
Baseline, 12 weeks, 24 weeks
2

Weight

Measured with Tanita mc-780MA body composition analyser. Will be used in conjunction with height to estimate Body Mass Index

Time frame
Baseline, 12 weeks, 24 weeks
3

Change in HDL

Assessment of fasting blood samples to evaluate High-Density Lipoprotein (HDL) cholesterol

Time frame
Baseline, 12 weeks, 24 weeks
4

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.

Time frame
Baseline, 12 weeks, 24 weeks

Other outcomes

Sponsors and contacts

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University College Dublin

Lead sponsor

St Vincent's University Hospital, Ireland

Collaborator

This trial is not recruiting at the moment. You can still explore other options: