Modulating Brain Activity to Improve Goal-directed Physical Activity in Older Adults (Stim-Fit)

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

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Device: Transcranial direct current stimulation (tDCS); Behavioral: Behavioral intervention to increase physical activity; Device: Sham stimulation

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Roslindale, Massachusetts, United States, 02131
      • Hebrew Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; 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.
Active Comparator: 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Daily Step Counts From Baseline	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.	Week 3-4, Week 5-6, Week 7-8, and Week 9-10.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hebrew SeniorLife
• Investigators: Principal Investigator: Brad Manor, PhD, Hebrew SeniorLife

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2020
• Primary Completion (Actual): November 3, 2022
• Study Completion (Actual): November 3, 2022

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB-2019-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The HSL Institute for Aging Research will promote the development of new research and new investigators by making the data available to outside investigators. The database will include longitudinal demographic, clinical, functional, physiologic, and brain imaging data, from all participants.

All data will be stripped of primary identifiers and entered into a master database. All data collection procedures, variable definitions and codes, field locations, and frequencies will be documented in a separate file.

• IPD Sharing Time Frame: The investigators will make the data and associated documentation available once summary data are published or otherwise made available, starting six months after publication.

IPD Sharing Access Criteria

The investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: 1) a commitment to using data only for research purposes and not to identify any particular participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed. The availability of data will be advertised over the Internet through websites maintained by Hebrew SeniorLife and Harvard Medical School.

All investigators wishing to access the data will submit a brief proposal describing their research project, data needs, regulatory approvals, and mechanisms to assure patient confidentiality. Upon affirmative review by the Principal Investigator and co-investigators of this study, a data-sharing agreement will be signed and the requesting investigators will be given a working data file and appropriate documentation.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No