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Completed

NCT Number: NCT05956730

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituti Clinici Scientifici Maugeri

Pavia, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.-

Treatment and study plan

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Sit to stand test (1-MSTS)

    Time frame: 3 months

    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.

  2. Sit and reach test (SR)

    Time frame: 3 months

    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. 3 minutes step test (3MST)

    Time frame: 3 months

    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.

  4. hand-grip test

    Time frame: 3 months

    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.

  5. Berg Balance Scale

    Time frame: 3 months

    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

  6. Satisfaction Profile (SAT-P) questionnaire

    Time frame: 3 months

    level of personal satisfaction and quality of life.

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 21, 2023
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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