Effects of a 12-Week Supervised Multicomponent Exercise Intervention Combining Interval Aerobic Training, Resistance Training and Inspiratory Muscle Training on Cardiorespiratory Fitness, Muscular Strength, Respiratory Function, Body Composition, Adherence and Acceptability in Adults With Severe Mental Disorder: A Single-Arm Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Maximal inspiratory pressure (MIP)
研究概览
简要总结
People with severe mental disorder, such as schizophrenia, bipolar disorder or major depression, tend to have poorer physical health and a shorter life expectancy than the general population. Exercise can help, but it is often difficult to keep up over time.
In this study, adults with severe mental disorder took part in a 12-week supervised exercise programme, with two sessions per week. Each session combined stationary cycling, strength exercises on machines, and training of the muscles used for breathing. The programme also included ongoing support and follow-up to help participants keep attending.
Fitness, strength, breathing function and body composition were measured before and after the programme. The researchers also recorded how many participants stayed until the end and how often they attended, and interviewed participants about their experience: what motivated them to join, what helped them continue, and what made it difficult.
The aim is to find out whether this kind of programme is feasible, safe and acceptable for people with severe mental illness, and what changes it produces in their physical health.
详细描述
Study design and setting
This is a single-arm, 12-week supervised exercise intervention conducted at the Centre for Sport and Physical Performance Research (CIRFD) of Universidad Pablo de Olavide, Seville, Spain. The setting is a university research facility rather than a clinical environment. Participants were recruited in collaboration with three mental health services of differing nature: a community social integration programme (Fundación Pública Andaluza para la Integración Social de Personas con Enfermedad Mental, FAISEM), a mental health day hospital (Hospital Universitario Nuestra Señora de Valme), and a residential therapeutic community (Comunidad Terapéutica de Salud Mental El Tomillar). Participants continued their usual psychiatric treatment throughout the intervention and received no financial compensation.
Intervention structure
The programme consists of 24 sessions delivered twice weekly over 12 weeks. Each session lasts 45-60 minutes and combines three consecutive training blocks: interval aerobic training, resistance training, and inspiratory muscle training. Participants train in groups of up to eight. Each session is supervised by an exercise professional with more than two years of experience working with adults with severe mental illness, a research support technician holding a degree in Sport and Exercise Sciences, and two Sport and Exercise Sciences students. Training loads are adapted at every session to the physical and mental state of each participant.
Aerobic training
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Medical diagnosis of severe mental disorder according to ICD-10 criteria
- •Aged between 18 and 65 years
- •Clinical stability confirmed by the participant's mental health professionals
- •Physically able to perform exercise
- •Able to travel to the intervention site
- •Written informed consent
排除标准
- •Acute psychiatric decompensation at the time of enrolment
- •Medical condition contraindicating exercise participation, including uncontrolled cardiovascular disease
- •Inability to complete baseline assessments
- •Currently participating in another structured exercise programme
研究组 & 干预措施
Multicomponent exercise intervention
Participants receive a 12-week supervised multicomponent exercise programme delivered twice weekly (24 sessions, 45-60 minutes each) in groups of up to eight, at a university sport and exercise research facility. Each session combines three consecutive blocks: interval aerobic training on a cycle ergometer individualised to peak power output, resistance training on digitally controlled machines individualised to estimated maximal strength, and inspiratory muscle training with a pressure threshold device individualised to maximal inspiratory pressure. Loads progress throughout the programme and are reassessed at week 6. Behaviour change strategies are applied to support adherence.
干预措施: Supervised multicomponent exercise programme (Other)
结局指标
主要结局
Maximal inspiratory pressure (MIP)
时间窗: Baseline and immediately after the 12-week intervention
Maximal inspiratory pressure, an index of inspiratory muscle strength, measured with a portable mouth pressure meter (MicroRPM; Micro Medical Inc., Chatham, Kent, UK). Participants perform repeated maximal inspiratory efforts from residual volume in standing position, and the highest value obtained is recorded. Values are expressed in cmH2O. Change is calculated as the difference between post-intervention and baseline assessment.
Forced vital capacity (FVC)
时间窗: Baseline and immediately after the 12-week intervention
Forced vital capacity, measured by spirometry (microQuark; COSMED, Rome, Italy) following standard procedures. Participants perform maximal forced expiratory manoeuvres and the highest acceptable value is recorded. Values are expressed in litres. Change is calculated as the difference between post-intervention and baseline assessment.
Peak oxygen uptake (VO2 peak)
时间窗: Baseline and immediately after the 12-week intervention
Peak oxygen uptake, measured during an incremental cardiopulmonary exercise test on a cycle ergometer (Ergoselect 200K; Ergoline, Bitz, Germany) with breath-by-breath gas analysis (K5; COSMED, Rome, Italy). Intensity is increased progressively until the participant cannot maintain a pedalling cadence of 60-70 rpm. Values are expressed in mL/kg/min. Change is calculated as the difference between post-intervention and baseline assessment.
Handgrip strength
时间窗: Baseline and immediately after the 12-week intervention
Maximal isometric handgrip strength, measured with a hand dynamometer (TKK; Takei Scientific Instruments Co. Ltd., Niigata, Japan) in standing position with the arm extended alongside the body. Participants perform repeated maximal attempts and the highest value is recorded. Values are expressed in kilograms. Change is calculated as the difference between post-intervention and baseline assessment.
Body composition assessed by dual-energy X-ray absorptiometry
时间窗: Baseline and immediately after the 12-week intervention
Whole-body composition, measured by dual-energy X-ray absorptiometry (Horizon A; Hologic Inc., Marlborough, MA, USA) following standard positioning and analysis procedures. Outcomes include total and regional fat mass (kg), lean mass (kg), body fat percentage, and bone mineral density (g/cm2). Change is calculated as the difference between post-intervention and baseline assessment.
Peak expiratory flow (PEF)
时间窗: Baseline and immediately after the 12-week intervention
Peak expiratory flow, measured by spirometry (microQuark; COSMED, Rome, Italy) during maximal forced expiratory manoeuvres. The highest acceptable value is recorded. Values are expressed in litres per minute. Change is calculated as the difference between post-intervention and baseline assessment.
次要结局
- Physical activity and sedentary behaviour(Baseline and immediately after the 12-week intervention)
- Retention rate(Through the 12-week intervention period)
- Session attendance rate(Through the 12-week intervention period)
- Adverse events(Through the 12-week intervention period)
- Acceptability of the intervention(At the end of the 12-week intervention)
- Peak power output(Baseline and immediately after the 12-week intervention)
- Walking capacity (Incremental Shuttle Walk Test)(Baseline and immediately after the 12-week intervention)
- Lower-limb functional strength (5-repetition Sit-to-Stand test)(Baseline and immediately after the 12-week intervention)
- Body composition assessed by bioelectrical impedance analysis(Baseline and immediately after the 12-week intervention)
- Isometric strength(Baseline and immediately after the 12-week intervention)
研究者
Camilo López Sánchez
Principal Investigator (designated)
Universidad Pablo de Olavide