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Executive DysfunctionNCT03733041

Neuromodulation for Exercise Adherence

A study testing Repetitive Transcranial Magnetic Stimulator and Nintendo Wii-Fit exercises in people with Executive Dysfunction and Poor Exercise Adherence, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
Repetitive Transcranial Magnetic Stimulator and Nintendo Wii-Fit exercises
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteUnited States
Study dates
1 Apr 2019to 31 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 16Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Central Arkansas Veterans Healthcare System , Little Rock, AR

    Little Rock, Arkansas, 72205

Other trials in United States

About this study

Official title: Neuromodulation for Exercise Adherence in Older Veterans

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.

Read the detailed description

Background: Fall-related hospitalizations and consequent morbidity and mortality continue to rise despite the availability for over two decades of evidence-based fall-prevention programs. This is a major problem since more than 2.5 million older adults are treated annually for fall-related injuries in the US. Fall-prevention programs focusing on strength and balance exercises have been successful in facility settings but exercise programs are ineffective at home due to lack of adherence. Estimates indicate that only 1 in 5 individuals adhere to home exercise programs for fall prevention. Thus, there is an urgent need to improve adherence to exercise performed at home by older adults seeking to improve balance for the sake of fall prevention. Behavioral interventions have failed to consistently improve adherence to exercise. Biological reasons for poor exercise adherence, such as executive dysfunction, have not been explored. Adherence to long-term exercise is dependent on executive function (EF), which is controlled by the [dorsolateral prefrontal cortex (DLPFC)] of the brain. EF influences choices in scheduling, forgoing competing activities, enduring subtle costs of time and inconvenience, and the ability to delay gratification. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation increasingly used for neural network specific interventions. rTMS of the DLPFC improves EF, memory, motivation, and mental flexibility. rTMS studies to date have stimulated the motor cortex for gait and balance improvements. The role of DLPFC in exercise adherence has not been explored. The proposed study will be the first to test DLPFC stimulation for improving exercise adherence.

Objective: The study objective is to determine the effects of rTMS treatment of the dorsolateral prefrontal cortex compared to sham on: [1. Short-term (2-wk) changes in executive function;] 2. Long-term (24-wk) adherence to a home-based exercise program; 3. Long-term (24-wk) changes in balance and gait; and [4. Short-term (2-wk) changes in self-efficacy and delay discounting.]

Methods: Sedentary community-dwelling older Veterans (age 60 years and older, [N=106]) will participate in a double-blind randomized sham-controlled three-phase study. The proposed study will use Nintendo Wii-Fit exercises. Phase I will include two weeks of facility-based exercise for safety assessment and learning the program, followed by 12 weeks of home-based exercises. [Subjects with poor adherence and those with good adherence with low EF] will then be randomized to rTMS or sham treatments. Phase II will include ten consecutive weekdays of rTMS or sham treatment along with exercise training for subjects with poor adherence [and for those with good adherence and low EF] and continuation of home-based exercises for those with good adherence and EF. Phase III includes 24-weeks of a home-based exercise program. All subjects will exercise for 45 minutes five days/week. [Objective measure of adherence collected from Wii-Fit console and Conner's continuous performance test for EF will be the primary outcome measures.] Balance and gait will be assessed. [Self-efficacy, delay discounting along with fear of falls, and falls incidence will be assessed. Outcome measures will be assessed at baseline, and at 14, 16, and 40 weeks.]

Significance: This project may have a major impact in improving adherence to an exercise program and in turn, improve balance in sedentary community-dwelling older Veterans. Knowledge gained about the adherence to home-based exercises would be applicable to multiple conditions such as diabetes. Since Wii-Fit and rTMS are readily available, translation of the study results to clinical practice would be expeditious.

Being tested
Repetitive Transcranial Magnetic Stimulator, Sham treatment, Nintendo Wii-Fit exercises
Keywords
exercise adherence, Older veterans, home based exercise

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Repetitive Transcranial Magnetic StimulatorDevice

    Also called Nintendo Wii-Fit exercises

    Participants randomized to this group will receive repetitive transcranial magnetic stimulation and will do Nintendo Wii-Fit exercises

  • Sham treatmentDevice

    Also called Nintendo Wii-Fit exercises

    Participants randomized to this group will receive sham treatment and will do Nintendo Wii-Fit exercises

  • Nintendo Wii-Fit exercisesDevice

    Participants will do Nintendo Wii-Fit exercises

Study groups in NCT03733041
Study groupRoleWhat they receive
Repetitive Transcranial Magnetic Stimulator (rTMS) treatment and Nintendo Wii-Fit exercises armActive comparatorThis group will be randomized to receive Repetitive Transcranial Magnetic Stimulator (rTMS) and Nintendo Wii-Fit exercises
Receives: Device: Repetitive Transcranial Magnetic Stimulator; Device: Nintendo Wii-Fit exercises
Sham treatment and Nintendo Wii-Fit exercises armSham comparatorThis group will be randomized to receive sham treatment and Nintendo Wii-Fit exercises
Receives: Device: Sham treatment; Device: Nintendo Wii-Fit exercises
Nintendo Wii-Fit exercises only armOtherThis group will not be randomized and receive only Nintendo Wii-Fit exercises
Receives: Device: Nintendo Wii-Fit exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Adherence as measured by number of minutes

    Total number of minutes exercised

    Measured: 14 weeks, 40 weeks

  2. Change in Conner's Continuous Performance Test

    Commission Error percentage Range 0-100% Higher score is improvement

    Measured: 14 weeks, 16 weeks, 40 weeks

  3. Change in Adherence as measured by number of sessions

    Total number of sessions exercised

    Measured: 14 weeks, 40 weeks

Secondary outcomes (2)
  1. Change in Gait speed

    The test measures habitual walking speed in meters/sec

    Measured: 14 weeks, 16 weeks, 40 weeks

  2. Change in Timed Up and Go

    This is a widely accepted test of pro-active balance and mobility and measured in secs

    Measured: 14 weeks, 16 weeks, 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2018
  2. Study start1 Apr 2019
  3. Primary completion31 Jan 2025
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to parallel groups to receive either the rTMS or sham treatment with allocation ratio of 1:1. The stratified randomization scheme will be generated by a statistician using a random block design with random block sizes, and assignments (X or Y) will be placed in sealed envelopes for sequential opening.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03733041
Sponsor's protocol ID
E2961-R
Status last verified
Jan 2026
First submitted
5 Nov 2018
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Repetitive Transcranial Magnetic Stimulator and Nintendo Wii-Fit exercises in people with Executive Dysfunction and Poor Exercise Adherence, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Adherence as measured by number of minutes (time frame: 14 weeks, 40 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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