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

Primary Purpose

Low Vision Blindness

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Physical Activity (AUD)
Physical Activity (SUP)
Sponsored by
Istituti Clinici Scientifici Maugeri SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Vision Blindness focused on measuring Physical Activity, Physical Performance, Quality of Life

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.-

Sites / Locations

  • Istituti Clinici Scientifici MaugeriRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

The proposed protocol includes a part of aerobic training and a subsequent part of strengthening exercises for large muscle groups. The total duration of each session will be approximately 30 minutes. There are 2 weekly training sessions for 3 months.

The proposed protocol includes a part of aerobic training and a subsequent part of strengthening exercises for large muscle groups. The total duration of each session will be approximately 30 minutes. There are 2 weekly training sessions for 3 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Sit to stand test (1-MSTS)
Functional evaluation of muscle power. Sitting on a chair without armrests (about 50cm high) and with his hands on his chest, the patient must get up and sit down as quickly as possible, as many times as possible within 1 minute.
Sit and reach test (SR)
Flexibility of the subject's posterior muscle kinetic chain. The subject seated with legs extended on the floor, with bare feet resting on a specific graduated cube, exhales and slowly bends the torso forward (without bending the knees) and tries to reach the farthest point of the cube with his own fingers.
3 minutes step test (3MST)
Assessment of aerobic capacity. Using a 15 cm high step (step), the subject is asked to go up and down the step as many times as possible in 3 minutes. The correct repetitions are recorded, i.e. when in the transition from the ground to the step and vice versa, both feet are on the ground and the knees are extended.
hand-grip test
assessment of generic strength (isometric specification of the hand flexors). The subject seated with his elbow resting on the table (respecting the angles between the bust and forearm according to the guidelines) squeezes a dynamometer with as much force as possible.
Berg Balance Scale
assessment of proprioceptive and balance skills through the execution of dynamic movements and the maintenance of static postures, in order to obtain information on the subject's motor skills, on the possible need for walking aids and on the risk of fall it presents
Satisfaction Profile (SAT-P) questionnaire
level of personal satisfaction and quality of life.

Full Information

First Posted
March 23, 2023
Last Updated
July 20, 2023
Sponsor
Istituti Clinici Scientifici Maugeri SpA
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1. Study Identification

Unique Protocol Identification Number
NCT05956730
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituti Clinici Scientifici Maugeri SpA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Vision Blindness
Keywords
Physical Activity, Physical Performance, Quality of Life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
The proposed protocol includes a part of aerobic training and a subsequent part of strengthening exercises for large muscle groups. The total duration of each session will be approximately 30 minutes. There are 2 weekly training sessions for 3 months.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
The proposed protocol includes a part of aerobic training and a subsequent part of strengthening exercises for large muscle groups. The total duration of each session will be approximately 30 minutes. There are 2 weekly training sessions for 3 months.
Intervention Type
Other
Intervention Name(s)
Physical Activity (AUD)
Intervention Description
Home training of patients with severe low vision managed through audio-guides (AUD).
Intervention Type
Other
Intervention Name(s)
Physical Activity (SUP)
Intervention Description
Training of patients with severe low vision in a gym supervised by a personal trainer (SUP).
Primary Outcome Measure Information:
Title
Timed up and go - version for the visually impaired (TUG-LV)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Sit to stand test (1-MSTS)
Description
Functional evaluation of muscle power. Sitting on a chair without armrests (about 50cm high) and with his hands on his chest, the patient must get up and sit down as quickly as possible, as many times as possible within 1 minute.
Time Frame
3 months
Title
Sit and reach test (SR)
Description
Flexibility of the subject's posterior muscle kinetic chain. The subject seated with legs extended on the floor, with bare feet resting on a specific graduated cube, exhales and slowly bends the torso forward (without bending the knees) and tries to reach the farthest point of the cube with his own fingers.
Time Frame
3 months
Title
3 minutes step test (3MST)
Description
Assessment of aerobic capacity. Using a 15 cm high step (step), the subject is asked to go up and down the step as many times as possible in 3 minutes. The correct repetitions are recorded, i.e. when in the transition from the ground to the step and vice versa, both feet are on the ground and the knees are extended.
Time Frame
3 months
Title
hand-grip test
Description
assessment of generic strength (isometric specification of the hand flexors). The subject seated with his elbow resting on the table (respecting the angles between the bust and forearm according to the guidelines) squeezes a dynamometer with as much force as possible.
Time Frame
3 months
Title
Berg Balance Scale
Description
assessment of proprioceptive and balance skills through the execution of dynamic movements and the maintenance of static postures, in order to obtain information on the subject's motor skills, on the possible need for walking aids and on the risk of fall it presents
Time Frame
3 months
Title
Satisfaction Profile (SAT-P) questionnaire
Description
level of personal satisfaction and quality of life.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Schmid, MD
Phone
+390382592735
Email
monica.schmid@icsmaugeri.it
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Decortes, Technician
Phone
+393477114804
Email
francesco.decortes@icsmaugeri.it
Facility Information:
Facility Name
Istituti Clinici Scientifici Maugeri
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Schmid, MD
Phone
+390382592735
Email
monica.schmid@icsmaugeri.it
First Name & Middle Initial & Last Name & Degree
Francesco Decortes, Technician
Phone
+393477114804
Email
francesco.decortes@icsmaugeri.it

12. IPD Sharing Statement

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

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