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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in body fat percentage
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Resistance training programme + Treatment as usual
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.
干预措施: Resistance training programme (Other)
Treatment as Usual
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
结局指标
主要结局
Change in body fat percentage
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Changes in fasting glucose(Baseline, 12 weeks, 24 weeks)
- Change in HbA1c(Baseline, 12 weeks, 24 weeks)
- Change in functioning(Baseline, 12 weeks, 24 weeks)
- Change in self-rated function(Baseline, 12 weeks, 24 weeks)
- Change in recovery scale scores(Baseline, 12 weeks, 24 weeks)
- Change in psychiatric symptoms(Baseline, 12 weeks, 24 weeks)
- Height(Baseline, 12 weeks, 24 weeks)