跳至主要内容
临床试验/NCT07113119
NCT07113119招募中不适用

Effects of a Long-term Exercise Training Program on the Functional Capacity and Health-related Quality of Life in Inpatients With Psychotic Disorders

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年8月4日最近更新:

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Evangelia Kouidi

Professor of Sports Medicine

Aristotle University Of Thessaloniki

研究点 (1)

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