Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05956730 |
Other study ID # |
2422 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 4, 2020 |
Est. completion date |
June 2024 |
Study information
Verified date |
December 2023 |
Source |
Istituti Clinici Scientifici Maugeri SpA |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
To evaluate the changes induced by exercise, subjects will undergo physical tests and
questionnaires, at the beginning and monthly until the end of the study.
It is expected that combined training should increase aerobic capacity and general strength
of the individual, as well as have a positive effect on quality of life and psychosocial
life, both using audio-guided and supervised training.
Obtaining these benefits with a self-managed training strategy would lead to greater
independence of the subject and would expand the possibility of intervention in the
population with low vision. Ultimately, these benefits could also be reflected in the
management of the person with low vision by the caregiver and close family members.