Neuromodulation for Exercise Adherence (NCT03733041) | Clinical Trial Compass
CompletedNot Applicable
Neuromodulation for Exercise Adherence
United States72 participantsStarted 2019-04-01
Plain-language summary
Lack of adherence to an exercise program is a major problem for older Veterans. Several fall prevention programs fail in the home setting due to lack of adherence. Exercise adherence is dependent on brain function among other factors. Magnetic stimulation of the front part of the brain improves brain function necessary for planning and following-through. The investigators propose a three-phase study in 106 sedentary older Veterans. Everyone will be trained on use of the exergames, Nintendo Wii-Fit, that the investigators' team has found beneficial in improving balance and gait. They will be asked to exercise using Wii-Fit at home for 45 minutes daily five days/week for 12-weeks. Those that exercise less than recommended dose and those that exercise adequately but have low executive function will receive either real or sham magnetic stimulation to the front part of their brain over ten sessions paired with exercise training. All subjects will further complete 24-weeks of Wii-Fit home exercises. Adherence, executive function, balance and gait, self-efficacy, delay discounting, and falls will be measured periodically.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Sedentary Community Dwelling Veterans age 60 years and older
* Have Television (TV) at home
* Subjects reporting spending long periods of time in sedentary behavior by answering affirmatively to the question: 'For most days, do you feel you sit for too long (6-8 hours or more a day)?
* Some examples might include when watching TV, working at the computer / laptop or when doing sitting-based hobbies such as reading and sewing' will be included
Exclusion Criteria:
GENERAL EXCLUSION CRITERIA
* Those that participate in regular physical activity for at least 30 minutes five or more days of the week
EXCLUSIONARY DUE TO Wii-Fit Exercises
* Use of wheel chair for mobility
* Cognitive impairment \[Montreal Cognitive Assessment (MoCA \< 26)\]
* Weight 325 lbs. (weight restriction of the Wii-Board)
* Absolute contraindications to exercise per The American College of Sports Medicine guidelines
* Those with medical conditions that in the opinion of the study physician are likely to compromise safe participation
EXCLUSIONARY DUE TO rTMS
* Taking medications known to increase risk of seizures from 2012 Beers criteria such as bupropion, chlorpromazine, clozapine.
* Taking other medications known to increase risk of seizures such as tricyclic antidepressants.
* Taking ototoxic medications: Aminoglycosides, CisplatinHistory of seizures/ seizures in first degree relatives
* Those with implanted device
* History of stroke, aneurysm, or cranial neurosurgery
* His…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Adherence as measured by number of minutes
Timeframe: 14 weeks, 40 weeks
2
Change in Conner's Continuous Performance Test
Timeframe: 14 weeks, 16 weeks, 40 weeks
3
Change in Adherence as measured by number of sessions