Non-invasive Brain Stimulation on Functional Capacity in Prefrail Older Adults
ConditionPrefrail Elderly
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-90
SponsorUniversity of Valencia
About this trial
The general objective of this study is to evaluate the effectiveness of non-invasive neuromodulation combined with a therapeutic exercise program on neuroplasticity and, therefore, on variables related to functional capacity and quality of life, in prefrail older adults.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 65 -90 years old
Meet 1-2 frailty criteria, according to Fried's Criteria.
Ability to understand instructions (Mini-Mental State Examination >23 points).
Signing of the informed consent.
Disqualifiers
History of stroke within the past 6 months or hospital admission for any reason within the past 3 months.
Alterations of the central or peripheral nervous system
Alterations of the vestibular system
Concomitant diseases
Trial design
Design model
Parallel
Treatments tested in this trial
tDCS
Other interventionThe tDCS will be performed anodically (a-tDCS), and for 24 sessions, 3 days a week. The electrodes will be mounted on a neoprene helmet, in accordance with the International Standard 10-20 EEG System, for optimal targeting of the primary motor cortex M1. It will be a type of unihemispheric application, in which the anode will be located in the primary motor cortex (M1), and the cathode located in the orbitofrontal cortex contralateral to the anode. The treatment parameters will be: stimulation time of 20 minutes; intensity of 2mA, current rise-fall time at the beginning and end of stimulation of 30 seconds. They will then perform the therapeutic exercise protocol explained above.
tDCS placebo
Other interventionThe instrumentation will be the same as in the actual tDCS intervention, but the device will be programmed to increase the intensity from 0 to 2 mA progressively during the first 30 seconds and then cease to provide the patient with the initial itchy sensation on the skin, similar to the real application. They will then perform the therapeutic exercise protocol explained above.
Virtual running
Other intervention24 sessions will be applied, 3 days a week. The patient will be placed standing (with an ad-hoc designed assistance system) in front of a mirror (located at waist height) and a height-adjustable screen (from waist to caudal) where a video of real legs running on a treadmill will be projected. In order for the participant to feel the projected legs as their own, people with different body sizes will have been previously recorded running to have recordings with legs of different size and length. Each session will last 20 minutes. They will then perform the therapeutic exercise protocol explained above.
Virtual running placebo
Other interventionThe instrumentation of the participants will be the same as in the intervention with virtual running. However, the projection will consist of a series of videos of landscapes in which no type of human or animal movement will appear in order not to stimulate the motor areas of the brain. They will then perform the therapeutic exercise protocol explained above.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: tDCS groupExperimental treatment 1 intervention
Group B: tDCS placebo groupPlacebo comparator 1 intervention
Group C: VR groupExperimental treatment 1 intervention
Group D: VR placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Frailty Condition
Fried's criteria (Frailty Phenotype) will be used. Briefly, the participant will be considered frail if he or she meets three or more of the following criteria: i) unintentional weight loss greater than 4.5 kg in the last year; ii) feeling of general exhaustion, reported by the patient himself; iii) low level of physical activity; (iv) slowness of progress; v) muscle weakness, assessed by handgrip strength. Those patients who meet one or two criteria will be considered pre-frail and those who do not meet either will be considered non-frail
Time frame
Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).2
Walking speed
The 10m Walking Test will be used to assess the speed of the walk, which records the time needed to cover the distance of 10m. The higher the walking speed, the greater the functional capacity
Time frame
Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).Secondary outcomes
1
Neuroplasticity
Neruoplasticity will be determined from the concentration of BDNF in plasma. A nurse will draw blood samples in BD Vacutainer® tubes, with EDTA as an anticoagulant. It will be centrifuged at 1500 G for 15 minutes at 4⁰ C, the supernatant (plasma) will be collected in eppendorf type tubes, which will be frozen at -80⁰ C until subsequent analysis. For the determination of BDNF levels, the ChemiKine™ BDNF Sandwich kit for ELISA (Millipore, Temecula, CA, USA) will be used, according to the manufacturer's instructions
Time frame
Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).2
Heart rate variability
HRV will be measured during 5 minutes at rest before intervention and during 20 minutes while performing aerobic exercise (walking). HRV will be measured with the PolarH10 band (Polar ®, Finland).
Time frame
Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).3
Muscle strength
Measurement of the isometric action of the lower limb muscles will be carried out by means of a load cell (Chronojump, Spain) connected to the corresponding software (Chronojump Boscosystem). Specifically, the isometric strength of the gluteus medius, quadriceps, and hamstrings will be measured. The participant will be asked for a maximum of three repetitions with a duration of five seconds each, and a rest between them of another thirty seconds. The maximum value will be recorded, as well as the average value of each of the three repetitions, and the average will then be obtained, which will be the variable used for the subsequent data analysis. As for upper limb strength, assessed by grip strength, this will be determined by a Lafayette hand dynamometer. 3 measurements of the dominant hand will be taken and the mean will be taken for further analysis. Higher values indicate greater muscle strength
Time frame
Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).4
Quality of life EQ-5D
Determined using the EQ-5D instrument, a measure of self-perceived health, consisting of two parts: the EQ-5D descriptive system, which assesses five dimensions of health (i.e. mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a visual analogue scale (VAS), in which people must estimate their general health status on a scale from 0 to 100. Higher values indicate greater quality of life.
Time frame
Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).Sponsors and contacts
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Source ClinicalTrials.gov