Clinical trial NCT05956730: Audio-guided Home Physical Activity to Support People With Low Vision: Physical Performance and Quality of Life
Official title: Audio-guided Home Physical Activity to Support People With Low Vision: Physical Performance and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Vision Blindness
Keywords: Physical Activity
Physical Performance
Quality of Life
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 23
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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 35.
* Subjects with pathologies that are not compatible with carrying out the physical activity protocol in safety and autonomy.-

Primary outcomes:
measure: Timed up and go - version for the visually impaired (TUG-LV)
timeFrame: 3 months
Secondary outcomes:
measure: Sit to stand test (1-MSTS)
timeFrame: 3 months
measure: Sit and reach test (SR)
timeFrame: 3 months
measure: 3 minutes step test (3MST)
timeFrame: 3 months
measure: hand-grip test
timeFrame: 3 months
measure: Berg Balance Scale
timeFrame: 3 months
measure: Satisfaction Profile (SAT-P) questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri
Study officials:
References: