Randomized Controlled Trial on the Effects of Traditional Exercise Programs on the Physical and Mental Health of Visually Impaired Individuals
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Single-Leg Stance Test
研究概览
简要总结
This study aims to investigate the benefits and underlying mechanisms of traditional exercise interventions on the physical and mental health of individuals with visual impairments. A randomized controlled trial design will be employed, enrolling 90 visually impaired participants who will be randomly assigned to one of three groups: a Tai Chi intervention group, a Baduanjin intervention group, or a control group. The Tai Chi group will undergo a 12-week simplified 21-form Tai Chi training program, while the Baduanjin group will receive standardized Baduanjin training. The control group will participate in regular school physical education classes. Eligible participants are university students with visual impairments, defined as having visual acuity ≤ 0.05 or a visual field radius ≤ 10 degrees.
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
- Triple (Participant, Care Provider, 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
- •University students with visual impairment, defined as visual acuity ≤ 0.05 or a visual field radius ≤ 10 degrees.
- •Able to ambulate independently without assistance.
- •No severe cardiovascular diseases.
排除标准
- •Presence of severe physical illnesses or comorbid conditions that may affect participation.
- •History of psychiatric disorders.
- •Participation in other structured exercise training programs within the past three months.
结局指标
主要结局
Single-Leg Stance Test
时间窗: Month 3
Assessment of static balance ability by measuring the duration participants can maintain a single-leg stance before and after the intervention.
Timed Up-and-Go (TUG) Test
时间窗: Month 3
Evaluation of dynamic balance and functional mobility using the timed up-and-go test, recorded at baseline and post-intervention.
Berg Balance Scale (BBS)
时间窗: Month 3
Measurement of overall balance performance using the 14-item Berg Balance Scale, administered before and after the intervention.
Six-Minute Walk Test (6MWT)
时间窗: Month 3
Assessment of cardiorespiratory endurance using the six-minute walk test at baseline and following the intervention.
Handgrip Strength Test
时间窗: Month 3
Evaluation of upper-limb muscular strength using a calibrated handgrip dynamometer, performed before and after the intervention.
Flexibility Test
时间窗: Month 3
Measurement of lower-body flexibility using a standardized sit-and-reach test conducted at baseline and post-intervention.
Self-Rated Depression Scale (SDS)
时间窗: Month 3
Assessment of depressive symptoms using the Self-Rated Depression Scale before and after the intervention.
Self-Rated Anxiety Scale (SAS)
时间窗: Month 3
Evaluation of anxiety symptoms using the Self-Rated Anxiety Scale administered at baseline and post-intervention.
General Self-Efficacy Scale (GSES)
时间窗: Month 3
Measurement of perceived self-efficacy using the General Self-Efficacy Scale at baseline and after the intervention.
WHO Quality of Life-BREF (WHOQOL-BREF)
时间窗: Month 3
Assessment of overall quality of life across physical, psychological, social, and environmental domains using the WHOQOL-BREF questionnaire, conducted before and after the intervention.
次要结局
未报告次要终点
研究者
Guang Yang, Prof. Dr.
Prof
Northeast Normal University