Effects of Therapeutic Exercise on Health-related Quality of Life and Disability in Students: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 主要终点
- SF-36v2 Health Survey
研究概览
简要总结
The main objective was to determine the efficacy and safety of a therapeutic exercise program for students. Secondary objectives, determine the prevalence and intensity of musculoskeletal pain (MSP), disability, Health-Related Quality of Life (HRQOL), and satisfaction and perceived improvement with program.
详细描述
Methodology: randomized, controlled, open clinical trial. Subjects were recruited from students of Degree of Physiotherapy. Inclusion and exclusion criteria were established. Physical Component Summary (PCS) of SF36, as primary outcomes, was taken to the sample size. Randomization was single-blind. Secondary response variables were measured through the Nordic Musculoskeletal Questionnaire, Visual Analogue Scale, Oswestry Disability Index, Neck Disability Index, trunk flexor endurance test and finger-floor distance test. An assessment pre and post intervention was performed. This consisted of a therapeutic exercise program based on the stabilization, 9 sessions of 1 hour. For statistical analysis, the Shapiro-Wilk test, Student's t test or test MannWitney, the statistic (X2) chi-square or Fisher's exact test were applied. The level of significance was taken as p <0.05. Information sheet and informed consent model was delivered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
盲法说明
This study was single-blind, parallel-group, and participants were randomly assigned to either the experimental (EG) or the control group (CG). Randomization was designed after initially evaluating the participants. The EG participated in the progressive exercise therapy program. In contrast, the CG did not receive any type of information or instructions apart from the general information sheet on the progress of the study, attached to the informed consent form.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •students taking a course of the Physiotherapy Degree
- •having enrolled in October 2014
- •having given their informed consent.
排除标准
- •not accepting to take part in the study,
- •not attending the initial evaluation sessions,
- •having any type of cardiovascular, neuromusculoskeletal or systemic diseases that restricted exercise participation.
结局指标
主要结局
SF-36v2 Health Survey
时间窗: 7 min
This is self-administered and consists of 36 items that assess the state of health in 8 dimensions: physical function (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social function (SF), role-emotional (RE) and mental health (MH). These dimensions may be reduced to 2 scores: Physical Component Summary (PCS) and Mental Component Summary (MCS). In order to interpret the results, standardized scores are obtained with the values for the reference population standards, whereby a score of 50 (SD = 10) represented the mean for the general population, and a score of 10 was one standard deviation. Values over or below 50 have to be respectively interpreted as better or worse than those of the reference population.
次要结局
- Visual Analogy Scale (VAS)(2 min)
- Oswestry Disability Index (ODI)(4 min)
- Neck Disability Index (NDI)(4 min)
- Flexor trunk endurance test(10 min)
- Nordic Musculoskeletal Questionnaire (NMQ-E)(4 min)
研究者
Beatriz Rodríguez-Romero
University Lecturer in the Department of Biomedical Sciences, Medicine and Physiotherapy. University of A Coruña
Universidade da Coruña