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

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

Overview

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

Interventions

• Other Resistance training programme
  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 re

Primary outcome measures

• Change in body fat percentage [Time frame: Baseline, 12 weeks]
• Number of participants recruited [Time frame: Baseline, 12 weeks, 24 weeks]
• Attendance by participants to intervention [Time frame: Baseline, 12 weeks, 24 weeks]

Secondary outcome measures (12)

• 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]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Prevention

Study locations

Ireland · 1 center

• St Vincent's University Hospital / University College Dublin — Dublin

Identifiers

NCT: NCT07386483 · START GAAIMS · ICAT-2022-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗