Improving exercise adherence in older veterans using brain stimulation
Neuromodulation for Exercise Adherence in Older Veterans
PHASE4 · VA Office of Research and Development · NCT03733041
This study is testing if brain stimulation can help older veterans stick to a regular exercise routine using the Nintendo Wii-Fit to stay active and reduce their risk of falls.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 1 site (Little Rock, Arkansas) |
| Trial ID | NCT03733041 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance exercise adherence among sedentary older veterans by utilizing repetitive transcranial magnetic stimulation (rTMS) to improve executive function. Participants will engage in home-based exercise using the Nintendo Wii-Fit for 45 minutes daily, five days a week, over a 12-week period. Those who struggle with adherence will receive either real or sham rTMS treatments alongside their exercise regimen. The study will assess the effectiveness of this combined approach in promoting consistent exercise habits and reducing fall risks.
Who should consider this trial
Good fit: Ideal candidates for this study are sedentary community-dwelling veterans aged 60 years or older who spend long periods in sedentary behavior.
Not a fit: Patients who regularly engage in physical activity or have cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve exercise adherence in older veterans, leading to better health outcomes and reduced fall-related injuries.
How similar studies have performed: While studies on rTMS have shown promise in improving cognitive functions, this specific approach to enhance exercise adherence in older adults is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Sedentary Community Dwelling Veterans age 60 years * Have 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 * History of bipolar disorder * History of abnormal electroencephalogram (EEG)
Where this trial is running
Little Rock, Arkansas
- Central Arkansas Veterans Healthcare System , Little Rock, AR — Little Rock, Arkansas, United States (RECRUITING)
Study contacts
- Principal investigator: Kalpana P Padala, MD MS — Central Arkansas Veterans Healthcare System , Little Rock, AR
- Study coordinator: Kalpana P Padala, MD MS
- Email: kalpana.padala@va.gov
- Phone: (501) 257-2044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Executive Dysfunction, Poor Exercise Adherence, exercise adherence, Older veterans, home based exercise