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Neuromodulation for Exercise Adherence

NCT03733041 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-02-02

No results posted yet for this study

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.

Conditions

  • Executive Dysfunction
  • Poor Exercise Adherence

Interventions

DEVICE

Repetitive Transcranial Magnetic Stimulator

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

DEVICE

Sham treatment

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

DEVICE

Nintendo Wii-Fit exercises

Participants will do Nintendo Wii-Fit exercises

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Kalpana P Padala, MD MS · Central Arkansas Veterans Healthcare System , Little Rock, AR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2025-01-31
Completion
2025-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03733041 on ClinicalTrials.gov