Mind in Motion: Multimodal Imaging of Brain Activity to Investigate Walking and Mobility Decline in Older Adults

Active, not recruiting

• Conditions: Effect of Age-related Changes in the Brain on Walking Ability

• Registration Number: NCT03737760
• Lead Sponsor: University of Florida

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-8
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Inclusion Criteria for Older Adults:<br><br> - Community dwelling men and women 65+ years old, or 60+ for individuals who belong to<br> underrepresented racial or ethnic groups;<br><br> - Short Physical Performance Battery (SPPB) <10 (45% of the sample will have an SPPB <<br> 8) for moderate to low functioning older adults; SPPB>=10 for high functioning older<br> adults<br><br> - Able to complete the 400 m walk test within 15 minutes without sitting or the help<br> of another person and without a walker, a cane is allowed<br><br> - Willingness to undergo all testing procedures<br><br> - English speaking<br><br> - Willingness to be enrolled for 1.25 to 3.5 years, depending on enrollment date.<br><br>Inclusion Criteria for Young Adults:<br><br> - Healthy men and women aged 20-40 years old<br><br> - Willingness to undergo all testing procedures<br><br> - English speaking<br><br>Exclusion Criteria for all participants:<br><br> - Significant medical event requiring hospitalization in the past 6 months that has<br> the potential to contaminate data being collected (fracture, hospitalization etc.);<br><br> - Severe visual impairment or corrected visual acuity less than 20/40, which would<br> preclude completion of the assessments;<br><br> - Not meeting MRI eligibility (e.g. metal implants, pacemaker, etc.)<br><br> - Clinically diagnosed vestibular dysfunction;<br><br> - Unwilling or unable to do an over-ground version of the uneven terrain task without<br> assistive device;<br><br> - Develops chest pain or severe shortness of breath during physical stress;<br><br> - Stroke or other brain injury within the past three years;<br><br> - Current presence of motor deficits caused by a stroke or other brain injury;<br><br> - Diagnosis of dementia or taking cholinesterase inhibitors (Aricept, Exelon,<br> Razadyne, Namenda, or Namzaric);<br><br> - Any major ADL disability (unable to feed, dress, bath, use the toilet, or transfer);<br><br> - Report of severe lower extremity pain that significantly limits mobility;<br><br> - Diagnosis or treatment for rheumatoid arthritis;<br><br> - Lives in a nursing home; persons living in assisted or independent housing will not<br> be excluded;<br><br> - Receiving physical therapy for gait, balance, or other lower extremity training;<br><br> - Known neuromuscular disorder or overt neurological disease (e.g. Multiple Sclerosis,<br> Rhabdomyolysis, Myasthenia Gravis, Ataxia, Apraxia, post-polio syndrome,<br> mitochondrial myopathy, Parkinson's Disease, ALS etc.)<br><br> - Unable to communicate because of severe hearing loss or speech disorder;<br><br> - Planned surgical procedure or hospitalization in the next 12 months (e.g., joint<br> replacement, CABG);<br><br> - Severe pulmonary disease, requiring the use of supplemental oxygen;<br><br> - Terminal illness, as determined by a physician;<br><br> - Severe cardiac disease, including NYHA Class III or IV congestive heart failure,<br> clinically significant aortic stenosis, recent history of cardiac arrest, use of a<br> cardiac defibrillator, or uncontrolled angina;<br><br> - Is planning to move out of the area in next year or leave the area for >6 mos during<br> follow-up;<br><br> - Other significant conditions that would impact safety and/or compliance to the<br> protocol (e.g. renal failure on hemodialysis, psychiatric disorder-bipolar,<br> schizophrenia, excessive alcohol intake etc.);<br><br> -Actively enrolled in an intervention study<br><br> - Use of walker or wheel chair;<br><br> - Artificial hair covering the scalp such as a wig or toupee<br><br> - Failure to provide informed consent;<br><br> - Transaminases >twice upper limit of normal;<br><br> - Hemoglobin <10 g/dL;<br><br> - Investigator discretion based on safety or compliance concerns<br><br> -Temporary exclusion criteria (participant may be eligible if these issues are<br> resolved in the future):<br><br> - Abnormalities in blood chemistry parameters as defined above;<br><br> - Severe hypertension, e.g., SBP > 200, DBP > 110 mmHg;<br><br> - Uncontrolled diabetes or hyperglycemia (fasting blood glucose > 126 mg/dl or<br> hemoglobin A1C > 6.5%)<br><br> - Other temporary events that would influence participation (e.g. episodic health<br> event, sick spouse, bereavement, or recent move);<br><br> - Other conditions identified with medical history at enrollment that places the<br> participant at risk for participation.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain activity during walking