NCT03733041

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

5.8 years

First QC Date

November 5, 2018

Last Update Submit

January 28, 2026

Conditions

Executive DysfunctionPoor Exercise Adherence

Keywords

exercise adherenceOlder veteranshome based exercise

Outcome Measures

Primary Outcomes (3)

  • Change in Adherence as measured by number of minutes

    Total number of minutes exercised

    14 weeks, 40 weeks

  • Change in Conner's Continuous Performance Test

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

    14 weeks, 16 weeks, 40 weeks

  • Change in Adherence as measured by number of sessions

    Total number of sessions exercised

    14 weeks, 40 weeks

Secondary Outcomes (2)

  • Change in Gait speed

    14 weeks, 16 weeks, 40 weeks

  • Change in Timed Up and Go

    14 weeks, 16 weeks, 40 weeks

Study Arms (3)

Repetitive Transcranial Magnetic Stimulator (rTMS) treatment and Nintendo Wii-Fit exercises arm

ACTIVE COMPARATOR

This group will be randomized to receive Repetitive Transcranial Magnetic Stimulator (rTMS) and Nintendo Wii-Fit exercises

Device: Repetitive Transcranial Magnetic StimulatorDevice: Nintendo Wii-Fit exercises

Sham treatment and Nintendo Wii-Fit exercises arm

SHAM COMPARATOR

This group will be randomized to receive sham treatment and Nintendo Wii-Fit exercises

Device: Sham treatmentDevice: Nintendo Wii-Fit exercises

Nintendo Wii-Fit exercises only arm

OTHER

This group will not be randomized and receive only Nintendo Wii-Fit exercises

Device: Nintendo Wii-Fit exercises

Interventions

Repetitive Transcranial Magnetic StimulatorDEVICE

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

Also known as: Nintendo Wii-Fit exercises
Repetitive Transcranial Magnetic Stimulator (rTMS) treatment and Nintendo Wii-Fit exercises arm
Sham treatmentDEVICE

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

Also known as: Nintendo Wii-Fit exercises
Sham treatment and Nintendo Wii-Fit exercises arm
Nintendo Wii-Fit exercisesDEVICE

Participants will do Nintendo Wii-Fit exercises

Nintendo Wii-Fit exercises only armRepetitive Transcranial Magnetic Stimulator (rTMS) treatment and Nintendo Wii-Fit exercises armSham treatment and Nintendo Wii-Fit exercises arm

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Those that participate in regular physical activity for at least 30 minutes five or more days of the week
  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Arkansas Veterans Healthcare System , Little Rock, AR

Little Rock, Arkansas, 72205, United States

Location

Study Officials

  • Kalpana P Padala, MD MS

    Central Arkansas Veterans Healthcare System , Little Rock, AR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Subjects and the study team (staff responsible for administering treatment or rating outcomes and study physicians) will not know the coil assignment since coils are labeled 'X' or 'Y' and are identical.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 7, 2018

Study Start

April 1, 2019

Primary Completion

January 31, 2025

Study Completion

May 31, 2025

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)