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

NCT05956730 | Completed

• 1 other identifier: 2422
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Vision Blindness

Keywords

Physical Activity; Physical Performance; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (6)

• Sit to stand test (1-MSTS)

  3 months

• Sit and reach test (SR)

  3 months

• 3 minutes step test (3MST)

  3 months

• hand-grip test

  3 months

• Berg Balance Scale

  3 months

Study Arms (2)

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.

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.

Other: Physical Activity (SUP)

Interventions

Physical Activity (AUD) OTHER

Home training of patients with severe low vision managed through audio-guides (AUD).

Group 1

Physical Activity (SUP) OTHER

Training of patients with severe low vision in a gym supervised by a personal trainer (SUP).

Group 2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.-

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri

Pavia, 27100, Italy

Location

Related Publications (1)

• 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.

  PMID: 41518011 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: July 21, 2023
• Study Start: November 4, 2020
• Primary Completion: December 15, 2023
• Study Completion: December 31, 2023
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

IT (1)