Low Vision BlindnessNCT05956730
Audio-guided Home Physical Activity to Support People With Low Vision: Physical Performance and Quality of Life
A study testing Physical Activity (AUD) and Physical Activity (SUP) in people with Low Vision Blindness, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Low Vision Blindness
- What is being tested?
- Physical Activity (AUD) and Physical Activity (SUP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 4 Nov 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.-
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Low Vision Blindness
- Being tested
- Physical Activity (AUD), Physical Activity (SUP)
- Keywords
- Physical Activity, Physical Performance, Quality of Life
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity (AUD)Other
Home training of patients with severe low vision managed through audio-guides (AUD).
Physical Activity (SUP)Other
Training of patients with severe low vision in a gym supervised by a personal trainer (SUP).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Other: Physical Activity (AUD) |
| Group 2 | Active comparator | 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. Receives: Other: Physical Activity (SUP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (6)
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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
Measured: 3 months
Satisfaction Profile (SAT-P) questionnaire
level of personal satisfaction and quality of life.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start4 Nov 2020
- Primary completion15 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Vision BlindnessStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956730
- Sponsor's protocol ID
- 2422
- Status last verified
- Jul 2024
- First submitted
- 23 Mar 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Correale L, Schmid M, Decortes F, Martinis L, Liberali G, Bandirali L, Cusella G, Montomoli C. Audio-guided exercise at home: Preliminary findings from a pilot study on physical activity for people with low vision. PM R. 2026 Jan 10. doi: 10.1002/pmrj.70081. Online ahead of print.
PubMed 41518011
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audio-guided Home Physical Activity to Support People With Low Vision: Physical Performance and Quality of Life
- ClinicalTrials.gov ID
- NCT05956730
- Acronym / sponsor ID
- 2422
- Conditions
- Low Vision Blindness
- Keywords
- Physical Activity, Physical Performance, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Physical Activity (AUD)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. |
| Group 2 | Active comparator | Other: Physical Activity (SUP)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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity (AUD)Home training of patients with severe low vision managed through audio-guides (AUD). | Other | Group 1 |
| Physical Activity (SUP)Training of patients with severe low vision in a gym supervised by a personal trainer (SUP). | Other | Group 2 |
Primary outcome
Timed up and go - version for the visually impaired (TUG-LV)
Time frame: 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.
6 secondary outcomes
Sit to stand test (1-MSTS)
Time frame: 3 months
Sit and reach test (SR)
Time frame: 3 months
3 minutes step test (3MST)
Time frame: 3 months
hand-grip test
Time frame: 3 months
Berg Balance Scale
Time frame: 3 months
Satisfaction Profile (SAT-P) questionnaire
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Derived from this study: PubMed 41518011Correale L, Schmid M, Decortes F, Martinis L, Liberali G, Bandirali L, Cusella G, Montomoli C. Audio-guided exercise at home: Preliminary findings from a pilot study on physical activity for people with low vision. PM R. 2026 Jan 10. doi: 10.1002/pmrj.70081. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity (AUD) and Physical Activity (SUP) in people with Low Vision Blindness, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed up and go - version for the visually impaired (TUG-LV) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05956730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.