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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04278560

Acronym

Stim-Fit

Enrollment

Registered

2020-02-20

Start date

2020-02-12

Completion date

2022-11-03

Last updated

2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

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.

Interventions

DEVICETranscranial 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.

DEVICESham 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.

BEHAVIORALBehavioral 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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 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.
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.
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.

Countries

United States

Participant flow

Pre-assignment details

Two participants signed the informed consent at the in-person screening but withdrew prior to the baseline assessment and were never randomized.

Participants by arm

Arm	Count
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. 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 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. 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.	16
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. 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 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.	16
Total	32

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	2
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Behavioral Intervention Plus Sham Stimulation	Total	Behavioral Intervention Plus tDCS
Age, Continuous	81.2 years STANDARD_DEVIATION 6	78.6 years STANDARD_DEVIATION 7.3	76.1 years STANDARD_DEVIATION 7.8
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) White	15 Participants	30 Participants	15 Participants
Sex: Female, Male Female	14 Participants	29 Participants	15 Participants
Sex: Female, Male Male	2 Participants	3 Participants	1 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 16	0 / 16
other Total, other adverse events	11 / 16	10 / 16
serious Total, serious adverse events	1 / 16	2 / 16

Outcome results

Primary

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Behavioral Intervention Plus tDCS	Change of Daily Step Counts From Baseline	Week 3-4	842 Steps per day	Standard Error 281
Behavioral Intervention Plus tDCS	Change of Daily Step Counts From Baseline	Week 7-8	1299 Steps per day	Standard Error 439
Behavioral Intervention Plus tDCS	Change of Daily Step Counts From Baseline	Week 5-6	1099 Steps per day	Standard Error 405
Behavioral Intervention Plus tDCS	Change of Daily Step Counts From Baseline	Week 9-10	1476 Steps per day	Standard Error 519
Behavioral Intervention Plus Sham Stimulation	Change of Daily Step Counts From Baseline	Week 9-10	866 Steps per day	Standard Error 448
Behavioral Intervention Plus Sham Stimulation	Change of Daily Step Counts From Baseline	Week 3-4	194 Steps per day	Standard Error 219
Behavioral Intervention Plus Sham Stimulation	Change of Daily Step Counts From Baseline	Week 5-6	408 Steps per day	Standard Error 443
Behavioral Intervention Plus Sham Stimulation	Change of Daily Step Counts From Baseline	Week 7-8	721 Steps per day	Standard Error 284

p-value: 0.009ANOVA

Secondary

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.

Time frame: Week 10

Arm	Measure	Value (MEAN)	Dispersion
Behavioral Intervention Plus tDCS	Completion Rate for Behavior Sessions	97 percentage of comleted sessions	Standard Error 2
Behavioral Intervention Plus Sham Stimulation	Completion Rate for Behavior Sessions	100 percentage of comleted sessions	Standard Error 0

p-value: 0.16t-test, 2 sided

Secondary

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.

Time frame: Week 4

Arm	Measure	Value (MEAN)	Dispersion
Behavioral Intervention Plus tDCS	Completion Rate for Brain Stimulation Sessions	98 percentage of comleted sessions	Standard Error 1
Behavioral Intervention Plus Sham Stimulation	Completion Rate for Brain Stimulation Sessions	99 percentage of comleted sessions	Standard Error 1

p-value: 0.46t-test, 2 sided

Secondary

Geriatric Depression Scale (15-item)

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