Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000475741
Ethics application status
Approved
Date submitted
11/02/2022
Date registered
25/03/2022
Date last updated
28/02/2023
Date data sharing statement initially provided
25/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a 12-Week Multi-Component Training Program with and without Transcranial Direct-Current Stimulation (tDCS) on Balance and frequency of Falls in Community-Dwelling Older Adults
Scientific title
Effectiveness of a 12-Week Multi-Component Training Program with and without Transcranial Direct-Current Stimulation (tDCS) on Balance and frequency of Falls in Community-Dwelling Older Adults
Secondary ID [1] 306124 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls Prevention 324797 0
Impaired balance 325243 0
Condition category
Condition code
Injuries and Accidents 322247 322247 0 0
Other injuries and accidents
Public Health 322248 322248 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 322838 0
Treatment: Other
Intervention code [2] 322998 0
Treatment: Devices
Comparator / control treatment
Control group will perform the same McTP program, but without tDCS stimulation.
Control group
Active

Outcomes
Primary outcome [1] 330438 0
Balance through Timed-up and go test
Timepoint [1] 330438 0
Before starting the intervention (week 1), six week after (week 6) and at the end of the intervention (week 12, primary timepoint).
Primary outcome [2] 330439 0
Activity-Specific Balance Confidence Scale (ABC)
Timepoint [2] 330439 0
Before starting the intervention (week 1), six week after (week 6) and at the end of the intervention (week 12, primary timepoint).
Secondary outcome [1] 406210 0
Risk of falling: The Fall Risk Index questionnaire (FRI-21) will be administered. It is a 21-item instrument that assesses both the internal and external factors present in the risk of falling. Each item is scored as 1 (risk) or 0 (no risk), with higher scores implying a greater falls risk. A 9 to 10 cut-off point is considered suitable for the early detection of fall risk.
Timepoint [1] 406210 0
Before starting the intervention (week 1), six week after (week 6) and at the end of the intervention (week 12).
Secondary outcome [2] 406211 0
Fear of falling: The Falls Efficacy Scale-International (FES-I), developed by the ProFaNE, will be applied. It is a 16-item self-report instrument that collects infor-mation on concerns about falls in a variety of daily activities, with excellent reliability and validity values (intraclass correlation coefficient = 0.96). Its score consists of a 4-point scale (from 1, “slightly worried”, to 4, “very worried”).
Timepoint [2] 406211 0
Before starting the intervention (week 1), six week after (week 6) and at the end of the intervention (week 12).
Secondary outcome [3] 406212 0
Number of falls: Participants will be asked the number of falls suffered in the last three months.
Timepoint [3] 406212 0
Before starting the intervention (week 1), six week after (week 6) and at the end of the intervention (week 12).
Secondary outcome [4] 406213 0
The 2-min walk test assesses the longest distance in metres that a person can walk along a rectangular path. It has high reliability, and its intraclass correlation coefficient is 0.888.
Timepoint [4] 406213 0
Before starting the intervention (week 1), six week after (week 6) and at the end of the intervention (week 12).
Secondary outcome [5] 406214 0
Lower body strength: The 30-s Chair Stand Test will be performed, which consists of sitting down and standing up from a chair for 30 s, counting the repetitions that the person can perform. Its reliability is considered high (0.87).
Timepoint [5] 406214 0
Before starting the intervention (week 1), six week after (week 6) and at the end of the intervention (week 12).
Secondary outcome [6] 406215 0
Lower limb flexibility: This will be measured by performing the Sit and Reach Test. Participants will sit with one leg extended and then slowly bend over, sliding their hands down the extended leg trying to touch (or pass) the toes of the toe line. The number of centimetres before reaching (negative score) or beyond (positive score) the toe will be recorded. Two attempts will be measured for each leg. The average of the best results of both legs will be considered for the analysis. Its intraclass correlation coefficient value is 0.92, which shows high reliability.
Timepoint [6] 406215 0
Before starting the intervention (week 1), six week after (week 6) and at the end of the intervention (week 12).
Secondary outcome [7] 406216 0
Speed: The Brisk Walking Test will be performed. The time taken to cover 30 m walking will be considered. Two repetitions will be conducted, with a one-minute rest between reps, taking the best repetition for the analyses. The test–retest reproducibility of this assessment is 0.95, and its Cronbach’s alpha coefficient of reproducibility is 0.96.
Timepoint [7] 406216 0
Before starting the intervention (week 1), six week after (week 6) and at the end of the intervention (week 12).
Secondary outcome [8] 406217 0
The Short Physical Performance Battery (SPPB) consists of three direct observation tasks: walking speed, balance, and the time taken to get up five times from a chair. The Cronbach’s alpha value is 0.70.
Timepoint [8] 406217 0
Before starting the intervention (week 1), six week after (week 6) and at the end of the intervention (week 12).
Secondary outcome [9] 406218 0
Self-perception of physical fitness: The International Fitness Scale (IFIS) will be administered. It permits us to obtain information about the participants’ general physical fitness self-perception, as well as their cardiorespiratory fitness, strength, speed-agility, and flexibility. This scale is composed of five questions with five response options (“very bad”, “bad”, “average”, “good” and “very good”).
Timepoint [9] 406218 0
Before starting the intervention (week 1), six week after (week 6) and at the end of the intervention (week 12).
Secondary outcome [10] 406219 0
Health-related quality of life: The Short Form-12 (SF-12) questionnaire will be used. This tool has eight elements (physical function, physical role, bodily pain, general health, vitality, social function, emotional role, and mental health), and two short components, physical and mental. The score ranges from 0 to 100 (0 being the worst and 100 being the best status). The SF-12 allows us to obtain the quality-adjusted life-years of life SF-6D.
Timepoint [10] 406219 0
Before starting the intervention (week 1), six week after (week 6) and at the end of the intervention (week 12).
Secondary outcome [11] 406220 0
Cognitive function: The Montreal Cognitive Assessment (MoCA) will be applied. It is a screening test for cognitive impairment that assesses eight cognitive domains (attention, executive functions, numeracy, language, working memory and recall, ab-straction, orientation, and visuospatial processing).
Timepoint [11] 406220 0
Before starting the intervention (week 1), six week after (week 6) and at the end of the intervention (week 12).
Secondary outcome [12] 406221 0
Safety: A log will be kept for each of the sessions in which any incident, injury or problem that arises will be noted, recording the possible origin of the problem.
Timepoint [12] 406221 0
Before starting the intervention and at the end of the intervention (week 12)
Secondary outcome [13] 406222 0
Applicability: The percentage of participants who carry out the programmed activities will be calculated. If an individual is not able to carry out the activities, the reason will be indicated. It will be recorded in a study-specific case file.
Timepoint [13] 406222 0
Before starting the intervention (week 1), six week after (week 6) and at the end of the intervention (week 12).

Eligibility
Key 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.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). After the initial assessment, a simple computer-generated randomisation sequence will be generated to assign the participants (1:1) to the experimental (McTP + tDCS) and control (McTP) groups using Research Randomizer software (Version 4.0, Geoffrey C. Urbaniak y Scott Plous, Middletown, CT, USA; http://www.randomizer.org. A researcher not involved in the study will prepare the randomization sequence. This information will be hidden in a password-protected file.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The statistical analysis will be conducted through the Statistical Package for the Social Sciences software (SPSS, Version 25, IBM SPSS, Armonk, NY, USA).
The characteristics of the study participants will be presented as the mean (standard deviation) and proportions for continuous and categorical variables, respectively. We will carry out an intention-to-treat (all participants), and a per-protocol analysis (individuals who complete the program).
Intention-to-treat analysis: All of the randomised participants will be considered for the analysis in their relevant group. Missing data will be imputed through multiple imputations. Repeated measures analyses of covariance (ANCOVA) adjusted by age and baseline outcomes will be applied to analyse the intervention effects on the different dependent variables. The baseline outcomes will be applied as a covariate for all of the dependent variables’ pre–post comparisons in order to avoid the bias of possible differences between the groups in the initial outcomes. The effect sizes (95% confidence interval) and differences for each variable concerning the time and the group × time interaction will be calculated. The alpha level will be set at p < 0.05. The data imputation for the sensitivity analyses will be conducted on patients who presented data at the baseline, and who completed the study, in order to avoid estimation bias.
Per-protocol analysis: The analyses previously described will be carried out but considering only those participants who attended at least 75% of the program sessions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/03/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment outside Australia
Country [1] 24570 0
Spain
State/province [1] 24570 0
Badajoz

Funding & Sponsors
Funding source category [1] 310473 0
University
Name [1] 310473 0
Universidad de Extremadura
Country [1] 310473 0
Spain
Primary sponsor type
University
Name
Universidad de Extremadura
Address
Av. de Elvas, s/n, 06006 Badajoz
Country
Spain
Secondary sponsor category [1] 311623 0
None
Name [1] 311623 0
Address [1] 311623 0
Country [1] 311623 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310103 0
Bioethics and Biosafety Committee at the University of Extremadura
Ethics committee address [1] 310103 0
Ethics committee country [1] 310103 0
Spain
Date submitted for ethics approval [1] 310103 0
09/12/2021
Approval date [1] 310103 0
15/12/2021
Ethics approval number [1] 310103 0
184/2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116482 0
Dr Laura Muñoz-Bermejo
Address 116482 0
Centro Universitario de Mérida, Calle Sta. Teresa Jornet, 38, 06800 Mérida, Badajoz
Country 116482 0
Spain
Phone 116482 0
+34 927 257460
Fax 116482 0
Email 116482 0
[email protected]
Contact person for public queries
Name 116483 0
Laura Muñoz-Bermejo
Address 116483 0
Centro Universitario de Mérida, Calle Sta. Teresa Jornet, 38, 06800 Mérida, Badajoz
Country 116483 0
Spain
Phone 116483 0
+34 927 257460
Fax 116483 0
Email 116483 0
[email protected]
Contact person for scientific queries
Name 116484 0
Laura Muñoz-Bermejo
Address 116484 0
Centro Universitario de Mérida, Calle Sta. Teresa Jornet, 38, 06800 Mérida, Badajoz
Country 116484 0
Spain
Phone 116484 0
+34 927 257460
Fax 116484 0
Email 116484 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.