NCT04278560

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Hebrew SeniorLife · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Aging

Interventions

Type	Name	Description
DEVICE	Transcranial direct current stimulation (tDCS)	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.
DEVICE	Sham stimulation	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	Behavioral intervention to increase physical activity	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.

Timeline

• Start date: 2020-02-12
• Primary completion: 2022-11-03
• Completion: 2022-11-03
• First posted: 2020-02-20
• Last updated: 2024-05-16
• Results posted: 2024-01-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study