None listed
Conditions
Brief summary
Approximately one-third of elderly people aged over 65 who live in the community experience falls every year, with the proportion increasing with age. Moreover, of those who fall, about half will fall again in the following year. The falls’ consequences include disability, morbidity, and mortality. Although many external and internal factors lead to falls, balance issues play a major role. Multi-component training programs (McTP) usually combine balance, strength, cardiorespiratory fit-ness, and flexibility, with studies reporting multiple benefits on the health-related quality of life. Halo Sport is a transcranial direct-current stimulation (tDCS) device with promising results for gait performance. This study aims to test the effectiveness of the introduction of a tDCS device to an McTP to prevent falls in older adults. The sample will consist of 44 people aged 65 years or older, randomly assigned to experimental (n = 22) and control (n = 22) groups. The experimental group will perform the McTP while wearing tDCS, and the control group will perform McTP without the device, for three sessions per week over 12 weeks. The main measures will provide information about (1) safety, (2) applicability, (3) balance, (4) number of falls, (5) physical fitness, (6) risk of falling, (7) fear of falling, (8) health-related quality of life, and (9) cognitive function. Among the practical implications of this program, it is intended to provide data on its safety and effectiveness to be implemented in different resources as a tool for the prevention of falls.
Interventions
A multicomponent training program (McTP) will be conducted. It will be composed of 3 sessions (30 min) per week over 12 weeks. Each session will be supervised by experts in the field. The structure of the sessions will consist of a 10-min warm-up (joint mobility, stretching), a 20-min main part of McTP exercises or activities wearing the Halo, and a 10-min cool-down (stretching, final thoughts and personal hygiene). The participants will wear the Halo only during the main part (20 min). The McTP
A multicomponent training program (McTP) will be conducted. It will be composed of 3 sessions (30 min) per week over 12 weeks. Each session will be supervised by experts in the field. The structure of the sessions will consist of a 10-min warm-up (joint mobility, stretching), a 20-min main part of McTP exercises or activities wearing the Halo, and a 10-min cool-down (stretching, final thoughts and personal hygiene). The participants will wear the Halo only during the main part (20 min). The McTP will consist of balance, strength, cardiorespiratory endurance, and flexibility exercises, with several of these components being trained in each session and with special focus on lower-limbs. All session will be drived by a professional of sports sciences and physical activity. Sessions will be delivered in group of no more than 10 children. The exercise will be only practiced during training sessions and under the supervision of instructors. At the end of each session, participants will be asked for their subjective perceived exertion though a Borg scale adapted to 10 levels. Adherence to intervention will be monitor by the instructors prior to start each session. The experimental group will perform the McTP while wearing the Halo Sport (Halo Neuroscience, San Francisco, CA, USA; https://www.haloneuro.com, accessed on 9 October 2021), a commercial tDCS device which is similar to audio headphones. Three-pointed foam electrodes (24 cm2/primer), moistened before use, will make electrical contact with the head. The Halo Sport will be placed on the vertex of the head after cleaning the stimulation area with alcohol swabs, and the integrated electrodes of the device will be saturated with water. The primers are located on the upper head to stimulate both sides of the motor cortex. The electrodes are linked to a DC electrical stimulator, powered by a lithiumion cell (LiPo 36 V). The anodal electrode is positioned on the top of the head, and the cathodal electrodes on the left and right sides. The current of the anodal tDCS will be set at 2 mA for 20 min, and will be monitored by the Halo Sport app in a mobile device. The participants will remain seated in a resting state while the Halo Sport headphones are placed on them, and will perform the exercises while equipped with the device.
Sponsors
Universidad de Extremadura
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
The participants will comply with the following inclusion criteria: (a) age equal or greater than 65 years old; (b) not suffering any pathology that contraindicates physical activity(the Physical Activity and Fitness Questionnaire (PAR-Q) will be run); (c) not presenting signs of cognitive impairment based on the Mini-Mental State Examination (scores greater than 25); (d) not presenting contraindications to tDCS use; (e) participants must pro-vide to the researchers a signed informed consent form; and (f) they must show moti-vation to participate in the program.
Exclusion criteria
The exclusion criteria will include: (a) living in a nursing home; (b) needing an assistive device to move or walk; (c) having any of the lower limbs amputated; or (d) presenting sensorial impairment that makes the normal development of exercise difficult.
Outcome results
None listed