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Completed

NCT Number: NCT04278560

Modulating Brain Activity to Improve Goal-directed Physical Activity in Older Adults

Although the majority of older adults are aware of the compelling evidence that regular exercise is critical to the maintenance of health into old age, most do not meet recommendations for daily exercise. This lack of engagement in 'goal-directed' physical activity stems from numerous interrelated factors including lack of motivation, depressed mood, and cognitive "executive" impairments that diminish one's ability to regulate behavior over time. Intriguingly, each of these factors has been linked to the function of brain networks that include the left dorsolateral prefrontal cortex (dlPFC). Transcranial direct current stimulation (tDCS) is a noninvasive and safe means of modulating the excitability of specific brain regions and their connected neural networks. tDCS designed to facilitate the excitability of the left dlPFC has been shown to improve motivation, mood, and multiple aspects of executive function in healthy adults. The investigators thus hypothesize that tDCS holds promise to increase goal-directed physical activity in older adults. This project aims to conduct a pilot randomized controlled trial on the feasibility and effects of a 2-week, 10-session tDCS intervention targeting the left dlPFC, combined with behavioral intervention aimed at increases daily physical activity, on physical activity over a two-month follow-up period, in relatively sedentary older adults without overt illness or disease.

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Key information

Conditions

Aging

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hebrew Rehabilitation Center

Roslindale, Massachusetts, 02131, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must live within subsidized housing in the Boston area
  • Self-report of exercising, on average, less than 150 minutes of at least moderate-intensity exercise per week, as determined by phone-screen completion of the International Physical Activity Questionnaire-Short Form (IPAQ short)

Exclusion criteria

  • An inability to ambulate without the assistance of another person (canes or walkers allowed)
  • Self-report of physician-diagnosed dementia, more than moderate cognitive impairment defined as a Montreal Cognitive Assessment (MoCA) score <21, or an inability to understand the study protocol as determined by study staff
  • A clinical history of stroke, Parkinson's disease or parkinsonian syndromes, multiple sclerosis, normal pressure hydrocephalus or other movement disorder affecting gait
  • Any report of severe lower-extremity arthritis or physician-diagnosis of peripheral neuropathy
  • Use of antipsychotics, anti-seizure, benzodiazepines, or other neuroactive medications
  • Severe depression defined by a Geriatric Depression Scale score greater than 11
  • Any report or physician-diagnosis of schizophrenia, bipolar disorder or other psychiatric illness
  • Any unstable medical condition
  • Resting systolic blood pressure is higher than 180 mmHg
  • Contraindications tor tDCS, including reported seizure within the past two years, use of neuro-active drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.

Sham stimulation

Device

An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue.

Behavioral Intervention to Increase Physical Activity

Behavioral

Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity.

Primary outcomes

  1. Change of Daily Step Counts From Baseline

    Time frame: Week 3-4, Week 5-6, Week 7-8, and Week 9-10.

    Absolute change in averaged daily step counts from two-week baseline (first two weeks, week 1-2). The specific periods are 1) absolute change in averaged daily step counts in week 3 and 4 from baseline, 2) absolute change in averaged daily step counts at week 5 and 6, from baseline, 3) absolute change in averaged daily step counts in week 7 and 8 from baseline, and 4) absolute change in averaged daily step counts in week 9 and 10 from baseline.

Secondary outcomes

  1. Motivation - External Regulation Score

    Time frame: Baseline; Week 4; Week 10

    External Regulation Score was calculated from the Exercise Self-Regulation Questionnaire (SQR-E). External regulation refers to motivation based on external sources such as incentives or coercion. Introjected regulation refers to motivation from an internalized, pressuring voice that was not accepting it as one's own. The External Regulation Score ranges from 4 to 28. The higher scores mean a better outcome.

  2. Timed Up-and-Go (TUG)

    Time frame: Baseline; Week 4; Week 10

    A common field test of mobility

  3. Trail Making Test (TMT) - A

    Time frame: Baseline; Week 4; Week 10

    Trail making test (TMT) A is a neuropsychological test of visual attention. The test requires the patient to connect randomly positioned numbered circles in numeric order as quickly as possible. It provides information about visual search speed and speed of processing. The test reliability for TMT A is 0.82. Time is measured in seconds.

  4. Trail Making Test (TMT) - B

    Time frame: Baseline; Week 4; Week 10

    Trail Making Test (TMT) - B is a neuropsychological test of task switching. The test requires the participants to connect the circles in numeric and alphabetic order as quickly as possible, alternating between numbers and letters. It provides information about executive function. The test reliability for TMT-B is 0.93. Time is measured in seconds.

  5. Montreal Cognitive Assessment (MoCA) Total Score

    Time frame: Baseline; Week 4; Week 10

    Global cognitive function. The range for this test is 0-30, with higher score representing better outcome.

  6. Geriatric Depression Scale (15-item)

    Time frame: Baseline; Week 4; Week 10

    Number of depressive symptoms. The range for this test is 0-15, with lower score representing better outcome.

  7. Completion Rate for Brain Stimulation Sessions

    Time frame: Week 4

    Ten stimulation sessions were planned for each participant over two weeks. This outcome presents the percentage of the completed brain stimulation sessions.

  8. Completion Rate for Behavior Sessions

    Time frame: Week 10

    Four bi-weekly behaviors sessions were planned for each participant over two months. This outcome presents the percentage of the completed behavior sessions.

Sponsors and collaborators

Lead sponsor

Hebrew SeniorLife

Other

Registry information

Official study title

Modulating Brain Activity to Improve Goal-directed Physical Activity in Older Adult

Acronym: Stim-Fit

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 20, 2020
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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