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

Официальное название

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

Обзор

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

Вмешательства

• Другое 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

Первичные конечные точки

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

Вторичные конечные точки (12)

• Body Mass Index [Срок оценки: Baseline, 12 weeks, 24 weeks]
• Weight [Срок оценки: Baseline, 12 weeks, 24 weeks]
• Change in HDL [Срок оценки: Baseline, 12 weeks, 24 weeks]
• Change in Muscular Strength (Upper and Lower Body) [Срок оценки: Baseline, 12 weeks, 24 weeks]
• Change in LDL [Срок оценки: Baseline, 12 weeks, 24 weeks]
• Changes in fasting glucose [Срок оценки: Baseline, 12 weeks, 24 weeks]
• Change in HbA1c [Срок оценки: Baseline, 12 weeks, 24 weeks]
• Change in functioning [Срок оценки: Baseline, 12 weeks, 24 weeks]
• Change in self-rated function [Срок оценки: Baseline, 12 weeks, 24 weeks]
• Change in recovery scale scores [Срок оценки: Baseline, 12 weeks, 24 weeks]
• Change in psychiatric symptoms [Срок оценки: Baseline, 12 weeks, 24 weeks]
• Height [Срок оценки: Baseline, 12 weeks, 24 weeks]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Ирландия · 1 центр

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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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