Status:
COMPLETED
CONTROL Walking Study
Lead Sponsor:
VA Office of Research and Development
Conditions:
Aging
Eligibility:
All Genders
65+ years
Phase:
PHASE1
Brief Summary
Older adults often experience substantial deficits in walking ability, especially for walking tasks that are more complex such as obstacle crossing. This is due in part to changes in the brain that ma...
Detailed Description
Aging often leads to substantial declines in walking function, especially for walking tasks that are more complex such as obstacle crossing. This is due in part to a lack of continued practice of comp...
Eligibility Criteria
Inclusion
- age 65 years or older
- preferred 10m walking speed \< 1.1 m/s
- self-report of "some difficulty with walking tasks, such as becoming tired when walking a quarter mile, or when climbing two flights of stairs, or when performing household chores."
- Willingness to be randomized to either study group and to participate in all aspects of study assessment and intervention
Exclusion
- Diagnosed neurological disorder or injury of the central nervous system, or observation of symptoms consistent with such a condition (Alzheimer's, Parkinson's, stroke, etc.)
- Contraindications to non-invasive brain stimulation (e.g., metal in head, wound on scalp)
- Contraindications to magnetic resonance imaging (e.g., metal in body, claustrophobia, etc).
- Use of medications affecting the central nervous system
- severe arthritis, such as awaiting joint replacement
- severe obesity (body mass index \> 35)
- current cardiovascular, lung or renal disease; diabetes; terminal illness
- myocardial infarction or major heart surgery in the previous year
- cancer treatment in the past year, except for nonmelanoma skin cancers and cancers having an excellent prognosis (e.g., early stage breast or prostate cancer)
- current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
- uncontrolled hypertension at rest (systolic \> 180 mmHg and/or diastolic \> 100 mmHg)
- bone fracture or joint replacement in the previous six months
- current participation in physical therapy for lower extremity function or cardiopulmonary rehabilitation
- current enrollment in any clinical trial
- difficulty communicating with study personnel, and/or non-English speaking
- planning to relocate out of the area during the study period
- clinical judgment of investigative team regarding safety or non-compliance
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03790657
Start Date
August 1 2019
End Date
August 1 2024
Last Update
September 22 2025
Active Locations (1)
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1
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608-1135