tDCS and the Cardiovascular System in Community-dwelling Elderly.

N/ANot Yet RecruitingNCT07573800

Riphah International University36 enrolled

Overview

This study could contribute to the advancements in healthcare by exploring the innovative intervention, which is Transcranial Direct Current Stimulation (tDCS). Investigating its impact on cardiovascular and locomotor outcomes could give rise to new non-pharmacological interventions for health promotion, disease prevention, and rehabilitation.

Age-related functional decline occurs in various organs like the cardiovascular system, brain, muscles, lungs, kidneys, and immune system in the body, contributing significantly to the onset of frailty in elderly individuals. Due to routine degeneration of aging, physical impairments related to movement take place, which include strength, balance, gait, and performance issues (5). Cardiovascular autonomic regulation is considered an important factor in health, while the autonomic nervous system is important for adapting therapy for prolonged cardiovascular outcomes. The process of aging can produce pathological changes in the cardiovascular system, whose results may lead to CVD. One of the main changes of aging is the augmented stiffness of central arteries, known as vascular aging. It occurs due to loss of elastic fibers and accumulation of collagen in the major elastic arteries, which leads to an increase in systolic and pulse pressures of healthy elderly individuals. These hemodynamic changes in vessels lead to clinical illness and increase the risk of developing hypertension, atherosclerosis, and stroke. While some other studies have shown that aging is also related to continuous decline in exercise capacity, walking ability, and physical function, impacting the performance of daily activity and maintaining personal independence. Walking limitation is very frequent in the elderly population, estimated at 58.1% to 93.2%, which can be a functional dependence risk factor among community dwellers. While increasing walking ability impacts several aspects of health-related quality of life, including physical, social, and emotional well-being. tDCS has a considerable impact on neuroplasticity and hypotension by delivering new interventional strategies to control blood pressure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Community-dwelling Elderly

Interventions

tDCSOTHER

The focal electrodes of 25-35 cm² will be placed on M1, identifying via the 10/20 EEG system.

Sham stimulationOTHER

Sham stimulation of the M1 area by using the 25-35 square centimeter electrodes.

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Able to ambulate independently (with or without assistive device) * Cognitively intact (MoCA score ≥ 24) * PAR-Q Exclusion Criteria: * History of seizures or epilepsy * Implanted metallic or electronic devices (e.g., pacemakers, ICD) * Uncontrolled hypertension (\>180/110 mmHg) * Severe cardiac, pulmonary, neurological, or orthopedic disorders limiting participation * Active skin conditions at electrode sites * Recent hospitalization (\<3 months) * Ongoing hormonal therapy, anticoagulants, or psychotropic medications

Locations (1)

Pakistan Railway Hospital

Rawalpindi, Punjab Province, Pakistan

Outcomes

Primary Outcomes

10-Meter Walk Test (10MWT)

The 10MWT is broadly used in preventive care and rehabilitation centers; it is evaluated by measuring participant speed and counting the number of steps taken within a given time period. This measurement method includes walking a certain section set on a smooth floor at the normal or maximum speed. After this, walking time and number of steps taken are to be measured

Time frame: baseline, week 1, and week 5

Blood Pressure Monitor

A sphygmomanometer is used to measure systolic and diastolic blood pressure before and after intervention sessions. The modified sphygmomanometer showed excellent test-retest reliability with an intraclass correlation coefficient (ICC) of 0.996.

Time frame: baseline, week 1, and week 5

6-Minute Walk Test (6MWT)

It is a sub-maximal exercise test used to assess aerobic capacity and endurance. Any change in performance capacity are determined based on the distance covered in six minutes. The 6MWT is a practically performed simple test that requires a 100-ft hallway but no exercise equipment needed. It helps to evaluates the global and integrated responses of all the systems involved during exercise, including the cardiovascular and pulmonary systems, systemic and peripheral circulation, blood, neuromuscular units, and muscle metabolism

Time frame: baseline, week 1, and 5

Short Physical performance battery

It consists of 3 timed components: 1) a 4-m usual pace walk, 2) a 5-repetition chair stand without using one's arms, and 3) a progressive test of standing balance. It is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults. The final total SPPB scores ranged between 4 and 12, with 4 to 6 representing the low, 7 to 9 the middle, and 10 to 12 the best performance.

Time frame: baseline, week 1, and 5

Heart rate variability (HRV)

Heart Rate Variability (HRV) in community-dwellers is a critical, non-invasive marker of autonomic nervous system function, with lower HRV values consistently predicting higher cardiovascular risk, mortality, and functional decline. Among community-dwelling older adults, reduced HRV is strongly associated with adverse health outcomes such as frailty, cognitive impairment, and depression.