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

NCT ID: NCT04278560

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-12
• Study Completion Date: 2022-11-03

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.

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Behavioral intervention plus 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.

Group Type: EXPERIMENTAL

Transcranial direct current stimulation (tDCS)

Intervention Type: 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.

Behavioral intervention to increase physical activity

Intervention Type: 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.

Behavioral intervention plus 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.

Group Type: ACTIVE_COMPARATOR

Sham stimulation

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hebrew SeniorLife

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brad Manor, PhD

Role: PRINCIPAL_INVESTIGATOR

Hebrew SeniorLife

Locations

Hebrew Rehabilitation Center

Roslindale, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IRB-2019-26

Identifier Type: -

Identifier Source: org_study_id