Exercise for Vision Impairment

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Severe diabetes, Cognitive deficit, others

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

14 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will determine whether blood biomarker changes predict sight-saving benefits of exercise.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for vision impairment?

Research shows that aerobic exercise can improve balance, walking ability, and quality of life in people with multiple sclerosis, which suggests it might also help with similar issues in vision impairment. ^{1 2 3 4 5}

Is exercise safe for people with vision impairment?

Exercise is generally safe for most people, including those with vision impairment. It offers many health benefits, such as improving heart health and reducing anxiety, with minimal risks compared to its benefits. ^{6 7 8 9 10}

How does the treatment of aerobic and balance exercise for vision impairment differ from other treatments?

This treatment is unique because it uses aerobic and balance exercises to potentially improve vision impairment, which is not a standard approach for this condition. While typically used to enhance cognitive function and physical fitness in conditions like traumatic brain injury and mild cognitive impairment, its application for vision impairment is novel and may offer benefits through improved blood flow and overall physical health. ^{2 4 11 12 13}

Research Team

Jeffrey H. Boatright, PhD

Principal Investigator

Atlanta VA Medical and Rehab Center, Decatur, GA

Eligibility Criteria

This trial is for English-speaking adults aged 18 to 89 who are mostly inactive, doing less than 120 minutes of aerobic exercise per week over the last three months. Participants should not have dementia (with an MMSE score of at least 24) and cannot join if they have severe diabetes requiring insulin or cognitive-executive function deficits (MoCA score below 26).

Inclusion Criteria

I am between 18 and 89 years old.

English speaking

You haven't been doing much aerobic exercise in the past 3 months, less than 2 hours per week.

Exclusion Criteria

You have trouble with thinking and problem-solving tests (MoCA score less than 26).

I have severe diabetes and need insulin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week aerobic exercise regimen to assess visual outcomes and serum biomarkers

12 weeks

3 times a week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Aerobic exercise
• Balance exercise

Trial Overview The study is testing whether regular aerobic and balance exercises can improve vision in people with visual impairments. It will also look at changes in blood biomarkers to see if they can predict the benefits of exercise on vision.

Participant Groups

Group I: Aerobic Exercise Active Control 1 Intervention

Exercise 3 times a week

Group II: Balance Training Placebo Group 1 Intervention

Group balance training 3 times a week

Aerobic exercise is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function
• Reduction of depression

Approved in European Union as Aerobic Exercise for:

• Cardiovascular rehabilitation
• Improvement of physical function
• Enhancement of cognitive function

Approved in Canada as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

An 8-week progressive aerobic exercise program was found to be feasible and well tolerated by five individuals recovering from moderate to severe traumatic brain injury (TBI), indicating that aerobic exercise can be safely integrated into their rehabilitation.

Participants successfully adhered to both the aerobic exercise and cognitive training, although measuring exercise intensity was challenging due to poor correlations between heart rate reserve and perceived effort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Aerobic Exercise in the Subacute Phase of Recovery From Traumatic Brain Injury: A Case Series. Morris, TP., Costa-Miserachs, D., Rodriguez-Rajo, P., et al.[2021]

Regular aerobic exercise significantly reduces the risk and mortality associated with coronary artery disease, likely due to its positive effects on blood lipid levels and blood pressure.

In addition to cardiovascular benefits, aerobic exercise also provides mental health advantages, such as reducing anxiety and depression, making it a valuable component in weight-loss programs and the management of conditions like diabetes and aging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health benefits of aerobic exercise. Mersy, DJ.[2019]

A 3-month community-based aerobic exercise training program showed a trend toward improved cardiorespiratory fitness (CRF) in individuals with traumatic brain injury (TBI), with an 8% increase in VO2peak compared to a 4% decrease in a stretching and toning group, indicating potential efficacy of aerobic exercise for this population.

The study demonstrated that while it is feasible to conduct exercise training in community settings for TBI patients, only 50% of participants adhered to the program, highlighting the need for strategies to improve adherence in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A proof-of-concept trial of a community-based aerobic exercise program for individuals with traumatic brain injury. Ding, K., Tarumi, T., Tomoto, T., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Effects of Concurrent Resistance and Aerobic Exercise Training on Functional Status in Patients with Multiple Sclerosis. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Aerobic Exercise in the Subacute Phase of Recovery From Traumatic Brain Injury: A Case Series. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Multiple sclerosis and brief moderate exercise. A randomised study. [2007]

4. England pubmed.ncbi.nlm.nih.gov

A pilot study of the effect of aerobic exercise on people with moderate disability multiple sclerosis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Dosage and Effectiveness of Aerobic Training on Cardiorespiratory Fitness, Functional Capacity, Balance, and Fatigue in People With Multiple Sclerosis: A Systematic Review and Meta-Analysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Effects of aerobic exercise on balance and mobility in individuals with visual impairment: a systematic review. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of exercise on ocular physiology and disease. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Health benefits of aerobic exercise. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of aerobic exercise on blood lipid and glucose in obese or overweight adults: A meta-analysis of randomised controlled trials. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Physical activity and risk of diabetic retinopathy: a systematic review and meta-analysis. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Effect of Exercise on Cognition, Conditioning, Muscle Endurance, and Balance in Older Adults With Mild Cognitive Impairment: A Randomized Controlled Trial. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Design of the ExCersion-VCI study: The effect of aerobic exercise on cerebral perfusion in patients with vascular cognitive impairment. [2023]

13. England pubmed.ncbi.nlm.nih.gov

A proof-of-concept trial of a community-based aerobic exercise program for individuals with traumatic brain injury. [2021]