Effects of a Long-term Exercise Training Program on the Functional Capacity and Health-related Quality of Life in Inpatients With Psychotic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- 30 -second Sit-to-stand test (STS)
研究概览
简要总结
Mental health represents a fundamental dimension of overall well-being, exerting a significant influence on mortality rates, health-related quality of life (HRQoL), levels of disability, and the strain on healthcare systems. As the interest in mental wellness continues to grow, exercise training (ET) has become increasingly recognized as a validated and effective intervention for individuals experiencing mental health challenges. An expanding body of research underscores the adverse effects of physical inactivity, reinforcing the role of exercise as a viable therapeutic strategy.
Well-structured ET interventions have consistently demonstrated benefits across multiple domains, including improvements in physical health, reductions in cardiovascular risk, and enhancements in psychological constructs such as depression, self-esteem, resilience, and self-efficacy. However, the majority of prior studies have been limited to relatively short durations-typically ranging from 4 to 24 weeks, with an average of about 12 weeks. A significant gap in the literature persists regarding the long-term implementation and effectiveness of ET programs, particularly in populations with severe mental illness. Additionally, the small sample sizes commonly seen in previous studies restrict the statistical robustness and generalizability of their outcomes.
The aim of the randomized control trial is to examine whether an 1-year mixed type exercise training program within the hospital setting will improve functional capacity and health-related quality of life. Forty- eight participants will be randomly allocated into two groups: Group A (Exercise group) will receive 3 exercise sessions per week for 1-year and Group B (Control Group) will continue their usual care, without participating in organized exercise programs. Prior to the group random allocation, part of the assessment at the baseline and 1 year follow-up will include lower extremity strength test, muscle power using a dynamometer, aerobic capacity test, balance test, body positioning and health- related quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being an adult
- •inpatient with a diagnosis of psychotic syndrome
- •on stable medication
- •controlled as far as psychosis is concerned
- •consenting to participate
排除标准
- •adolescents
- •with other diagnoses
- •not on stable medication
- •in an unstable condition
- •unwilling to participate in the study
结局指标
主要结局
30 -second Sit-to-stand test (STS)
时间窗: Follow-up assessment, 12 months post- baseline
Evaluation of functional capacity and mobility using 30-second STS
Isometric Lower Extremity Strength Assessment in Semi-Squat Using Baseline Leg Dynamometer
时间窗: Follow-up assessment, 12 months post- baseline
The isometric strength of the lower extremities is evaluated in a semi-squat position using a Baseline Leg Dynamometer, with muscular strength quantified in kilograms (kg).
Handgrip Strength
时间窗: Follow-up assessment, 12 months post- baseline
Evaluation of the isometric handgrip strength using a hand dynamometer
Six- Minute Walking Test
时间窗: Follow-up assessment, 12 months post- baseline
Estimation of aerobic capacity through six minute walking test
Short form Quality of Life (SF-36)
时间窗: Follow-up assessment, 12 months post- baseline
Assessment of Quality of Life using SF-36
Sit-and-Reach Test
时间窗: Follow-up assessment, 12 months post- baseline
Evaluation of flexibility using sit- and- reach test
Berg Balance Scale Test
时间窗: Follow-up assessment, 12 months post- baseline
Evaluation of balance using Berg Balance Scale Test
次要结局
未报告次要终点
研究者
Evangelia Kouidi
Professor of Sports Medicine
Aristotle University Of Thessaloniki
