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临床试验/NCT05956730
NCT05956730已完成不适用

Audio-guided Home Physical Activity to Support People With Low Vision: Physical Performance and Quality of Life

Istituti Clinici Scientifici Maugeri SpA2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2020年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Timed up and go - version for the visually impaired (TUG-LV)

研究概览

简要总结

The aim of the project is to investigate the effectiveness of a home training managed through audio-guides in comparison to a classic supervised training on the physical and psychological parameters of patients with severe low vision.

In this study the feasibility and effectiveness of a self-managed physical activity protocol with audio guides on physical performance (strength, mobility and aerobic capacity) will be assessed and compared to the same protocol supervised in a fitness environment.

Secondary aims are the effects of the two types of administration of the protocol on quality of life, autonomy and psychological impact on the caregiver.

详细描述

According to the World Health Organization, low vision is that condition of permanent reduction of the visual function which does not allow an individual to fully develop his relationship activity, conduct a normal work activity, pursue his needs and aspirations of life. The increase in life expectancy on the one hand and the increasingly better ability to prevent and treat serious eye diseases, has led in industrialized countries to extraordinarily high numbers of patients who develop serious hypovision in adulthood or advanced age.

Since regular physical activity is essential for maintaining good health in older adults, even those with limited mobility, to maintain muscle mass and good balance (thus preventing falls) the use of audio devices or workouts carried out through audio guides for management of exercises in autonomy and at home will be tested. The aim of the project is to investigate the effectiveness of a home training protocol managed through audio-guides, in comparison to a classic supervised training, on the physical and psychological parameters of patients with severe low vision.

Participants (people with severe low vision) will be randomized into two groups: "audio" group (AUD), trained through exercises explained through audio files and "supervised" group (SUP), trained in a gym supervised by a personal trainer.

The training protocol will have a total duration of 3 months, with 2 weekly sessions and a monthly re-planning of loads and intensities.

The participants of the SUP group will be trained at the Adapted Motor Activity Laboratory (LAMA) of the University of Pavia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Residual visus up to 1/10 or residual binocular perimeter less than 30% (Severely visually impaired);
  • age greater than or equal to 50 years;
  • sedentary lifestyle, PASIPD questionnaire value less than 13.2 Mets hours/day;
  • sedentary lifestyle, IPAQ-SF questionnaire value less than 700 Mets/week;
  • absence of autonomous mobility with white cane.
  • proprioceptive and balance skills such as to allow the protocol to be managed independently and safely, value of the Berg Balance Scale test greater than 35.

排除标准

  • Subjects who report habitual physical activity or sports;
  • PASIPD questionnaire value greater than 13.2 Mets hours/day.
  • Subjects at high risk of falling, with a Berg Balance Scale test value of less than
  • Subjects with pathologies that are not compatible with carrying out the physical activity protocol in safety and autonomy.-

结局指标

主要结局

Timed up and go - version for the visually impaired (TUG-LV)

时间窗: 3 months

Assessment of functional walking ability. In this version for patients with visual impairments, the subject must get up from the chair and walk 6 meters to a luminous point (light point) and go back to sit down as quickly as possible.

次要结局

  • Sit to stand test (1-MSTS)(3 months)
  • Sit and reach test (SR)(3 months)
  • 3 minutes step test (3MST)(3 months)
  • Berg Balance Scale(3 months)
  • hand-grip test(3 months)
  • Satisfaction Profile (SAT-P) questionnaire(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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