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Trial registered on ANZCTR


Registration number
ACTRN12622000264785
Ethics application status
Approved
Date submitted
3/12/2021
Date registered
14/02/2022
Date last updated
14/02/2022
Date data sharing statement initially provided
14/02/2022
Date results information initially provided
14/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of the application of a TDCs treatment and combined exercise program on fragility in a population wtih Multiple Sclerosis
Scientific title
Effectiveness of the application of a TDCs treatment and combined exercise program on fragility in a population wtih Multiple Sclerosis
Secondary ID [1] 305962 0
Nil known
Universal Trial Number (UTN)
U1111-1272-1873
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 324561 0
Condition category
Condition code
Physical Medicine / Rehabilitation 322029 322029 0 0
Physiotherapy
Neurological 322325 322325 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcraneal Direct Current stimulation treatment:
For the application of Transcranial Direct Current, the Neuronika HDCstim stimulator was used: #HS0042/01-13; HDcel: #HE0021/02-13. Direct current was applied to the scalp through 35cm2 sponge electrodes with a current intensity of 2mA. The electrodes were soaked in a saline solution to minimize the risk of skin irritation and damage.
The stimulation electrodes will be fixed with the help of an adjustable head mesh used the 10-20 EEG system. The anode will be placed in the left DLPFC region (F3 according to the 10-20 EEG system), while the cathode will be placed in the right supraorbital cortex. During the session the current was ramped up during the first 15 seconds to a maximum of 2mA that was maintained throughout the 20-minute stimulation session. A specialized physiotherapist will apply it in a total of 10 sessions of 20 minutes duration for 4 weeks.
Exercise program
The exercise program applied by a specialized physiotherapist, consists of a concurrent type of training, where strength exercise is combined with aerobic exercise.
The exercise plan was carried out for 4 weeks, performing the strength and aerobic sessions on different days and with progressive load. The program was executed by the patients individually, because they had the possibility to choose the type of exercise according to their capabilities.
In this way, the strength training will be distributed in the form of a circuit, composed of 6 exercises in which push and pull exercises of the lower and upper limbs, pelvic girdle and trunk are worked. Two circuits A and B were developed, so that the subjects could choose in case any of the exercises were complex to perform. In addition, the repetitions to be performed will be set, as well as the rest time between exercises and circuits. Each subject will begin week 1 by performing 2 sessions, on alternate days, of 6 exercises with 15 repetitions of each exercise and 2 minutes of rest between exercises, repeated 2 times. In week 4 this subject will perform 3 sessions, on alternate days, of 6 exercises with 10 repetitions of each exercise and 3 minutes rest between exercises, repeated 3 times.
Some of the examples of the strength exercises performed are as follows:
- Upper limb traction: rowing with theraband
-Upper limb thrust: elbow extension against resistance with theraband
-Knee extension and flexion against resistance
-Extension and flexion of the hip against resistance
-Core work to choose between bridge and plank
The aerobic training will be increased from 1 session of 10 minutes in week 1, to 2-3 sessions (depending on the subject's capacity) of 30 minutes with 5 minutes rest between sessions. The intensity used was moderate, which corresponds to a level 3-5 on the rating scale of perceived exertion. Static bike or Motomed kinesiotherapeutic equipment were used depending on the participant's preference.
An attendance checklist was used to control the implementation of the program.
Intervention code [1] 322351 0
Treatment: Devices
Intervention code [2] 322352 0
Treatment: Other
Intervention code [3] 322353 0
Rehabilitation
Comparator / control treatment
The study design uses an active control group, by means of a crossover design. In this type of study, each participant receives both interventions, always in a specific order and in an established period of time. In this way, each subject acts as his or her own control, experiencing both interventions in an established sequence of periods and separated by a stabilization or washout period, which in this case was 5 months.
Control group
Active

Outcomes
Primary outcome [1] 329782 0
Beck depression inventory-ii
Timepoint [1] 329782 0
Before each intervention and post treatment
Primary outcome [2] 329783 0
Timed up and go test for the assessment of functional mobility
Timepoint [2] 329783 0
Before each intervention and post treatment
Primary outcome [3] 329784 0
Tinetti balance test
Timepoint [3] 329784 0
Before each intervention and post treatment
Secondary outcome [1] 403751 0
Fatigue: Fatiga Modified Fatigue Impact Scale (MFIS) questionnaire
Timepoint [1] 403751 0
Before each intervention and post treatment

Eligibility
Key inclusion criteria
Inclusion criteria:
- Diagnosis of Multiple Sclerosis
- Score indicating the presence of fatigue on the Modified Fatigue Impact Scale (MFIS)
- Ability to walk at least 20 meters without resting,
- Good written and spoken Spanish comprehension.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with other diseases that could affect muscle function, as well as those with a cardiovascular risk profile, respiratory disease, severe pulmonary disease or other diseases that could interfere with compliance with the exercise program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Initially, the total sample should be made up of 27 participants to have a effect size of 0.5 and an alpha error of 0.05.
However, only 15 participants were able to participate in the study in accordance with the selected inclusion and exclusion criteria.
The statistical methods to be used will be correlations, T-test for related samples and correlations between variables with Pearson Correlations .

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The study was interrupted due to the sanitary measures imposed by Covid-19.
Date of first participant enrolment
Anticipated
Actual
2/03/2020
Date of last participant enrolment
Anticipated
Actual
1/09/2020
Date of last data collection
Anticipated
Actual
19/04/2021
Sample size
Target
27
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 24366 0
Spain
State/province [1] 24366 0
Palencia

Funding & Sponsors
Funding source category [1] 310304 0
Charities/Societies/Foundations
Name [1] 310304 0
Asociación Esclerosis Múltiple Palencia
Country [1] 310304 0
Spain
Primary sponsor type
University
Name
Leon University
Address
Av. Facultad de Ciencias de la Salud, Campus Vegazana, s/n. 24071 León-España
Country
Spain
Secondary sponsor category [1] 311699 0
None
Name [1] 311699 0
Address [1] 311699 0
Country [1] 311699 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309966 0
Ethics committee of University of Leon
Ethics committee address [1] 309966 0
AV. Facultad de Ciencias de la Salud. Campus Vegazana, s/n. 24071 León
Ethics committee country [1] 309966 0
Spain
Date submitted for ethics approval [1] 309966 0
Approval date [1] 309966 0
30/03/2020
Ethics approval number [1] 309966 0

Summary
Brief summary
The objectives of the study will focus on the analysis of the depression, functional mobility and balance after the treatment of fatigue with application of transcranial direct current and exercise. Also, the relationships between depression, functional mobility, balance and physical activity, fatigue and sociodemographic data will be analyzed. Our hypothesis is that subjects receiving these treatments will show an improvement in depression, functional mobility, balance and in the variable fatigue.
A crossover design will be used where each subject acts as their own control with a washout period of 5 months.
Transcranial Direct Current will be initially applied by a specialized physiotherapist in a total of 10 sessions of 20 minutes duration for 4 weeks.
After the washout period a concurrent type of training will be applied by a specialized physiotherapist. The program was distributed in 4 weeks where the sessions were progressively increased in level. The strength training was programmed in the form of a circuit, composed of 6 exercises where pushing and pulling exercises of the lower and upper limbs, pelvic girdle and trunk are worked. Two circuits A and B were developed, so that the subjects could choose if any of the exercises were complex to perform. In addition, the repetitions to be performed, as well as the rest time between exercises and circuits, were established.
Aerobic training was increased from 1 session of 10 minutes in week 1 to 2-3 sessions (depending on the subject's capacity) of 30 minutes with 5 minutes rest between sessions. The intensity used was moderate, which corresponds to a level 3-5 on the rating scale of perceived exertion.
Trial website
Trial related presentations / publications
Public notes
Due to the quarantine imposed by Covid-19 the processing of the ethics committee document was delayed until 30/03/2020, but acceptance by the department and the committee was obtained prior to the inclusion of the first participant.

Contacts
Principal investigator
Name 116014 0
Miss Inés Muñoz Paredes
Address 116014 0
University of Leon. AV. Facultad de Ciencias de la Salud. Campus Vegazana, s/n 24071 León
Country 116014 0
Spain
Phone 116014 0
+34650092601
Fax 116014 0
Email 116014 0
imunoz30493@gmail.com
Contact person for public queries
Name 116015 0
Miss Ines muñoz Paredes
Address 116015 0
University of Leon. AV. Facultad de Ciencias de la Salud. Campus Vegazana, s/n 24071 León
Country 116015 0
Spain
Phone 116015 0
+34650092601
Fax 116015 0
Email 116015 0
imunoz30493@gmail.com
Contact person for scientific queries
Name 116016 0
Miss Ines muñoz Paredes
Address 116016 0
University of Leon. AV. Facultad de Ciencias de la Salud. Campus Vegazana, s/n 24071 León
Country 116016 0
Spain
Phone 116016 0
+34650092601
Fax 116016 0
Email 116016 0
imunoz30493@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator (imunop00@estudiantes.unileon.es)


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
SourceTitleYear of PublicationDOI
EmbaseThe Effect of Combining Transcranial Direct Current Stimulation Treatment and an Exercise Program on Fragility in a Population with Multiple Sclerosis: Cross-Over Design Trial.2022https://dx.doi.org/10.3390/ijerph191912747
N.B. These documents automatically identified may not have been verified by the study sponsor.