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

Not Applicable

Completed

Conditions: Aging

Interventions: Device: Sham stimulation
Device: Transcranial direct current stimulation (tDCS)
Behavioral: Behavioral intervention to increase physical activity

Registration Number: NCT04278560

Lead Sponsor: Hebrew SeniorLife

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 34

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral intervention plus sham stimulation	Behavioral intervention to increase physical activity	This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation.
Behavioral intervention plus sham stimulation	Sham stimulation	This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation.
Behavioral intervention plus tDCS	Behavioral intervention to increase physical activity	This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex.
Behavioral intervention plus tDCS	Transcranial direct current stimulation (tDCS)	This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex.

Primary Outcome Measures

Name	Time	Method
Change of Daily Step Counts From Baseline	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 Outcome Measures

Name	Time	Method
Completion Rate for Brain Stimulation Sessions	Week 4	Ten stimulation sessions were planned for each participant over two weeks. This outcome presents the percentage of the completed brain stimulation sessions.
Montreal Cognitive Assessment (MoCA) Total Score	Baseline; Week 4; Week 10	Global cognitive function. The range for this test is 0-30, with higher score representing better outcome.
Geriatric Depression Scale (15-item)	Baseline; Week 4; Week 10	Number of depressive symptoms. The range for this test is 0-15, with lower score representing better outcome.
Completion Rate for Behavior Sessions	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.
Motivation - External Regulation Score	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.
Timed Up-and-Go (TUG)	Baseline; Week 4; Week 10	A common field test of mobility
Trail Making Test (TMT) - A	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.
Trail Making Test (TMT) - B	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.