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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 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]

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

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Neurological

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]

Treatment: Devices

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

Beck depression inventory-ii

Timepoint [1]

Before each intervention and post treatment

Primary outcome [2]

Timed up and go test for the assessment of functional mobility

Timepoint [2]

Before each intervention and post treatment

Primary outcome [3]

Tinetti balance test

Timepoint [3]

Before each intervention and post treatment

Secondary outcome [1]

Fatigue: Fatiga Modified Fatigue Impact Scale (MFIS) questionnaire

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Palencia

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Asociación Esclerosis Múltiple Palencia

Address [1]

Aspaym Palencia: C/ Lola de la Fuente s/n, Estadio Nueva balastera. Puerta 4. 34004 – Palencia
Esclerosis Múltiple Palencia: Pl. de los Juzgados, 4, 3ª, 34001 Palencia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics committee of University of Leon

Ethics committee address [1]

AV. Facultad de Ciencias de la Salud. Campus Vegazana, s/n. 24071 León

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

Approval date [1]

30/03/2020

Ethics approval number [1]

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

Miss Inés Muñoz Paredes

Address

University of Leon. AV. Facultad de Ciencias de la Salud. Campus Vegazana, s/n 24071 León

Country

Spain

Phone

+34650092601

Fax

imunoz30493@gmail.com

Contact person for public queries

Name

Ines muñoz Paredes

Address

University of Leon. AV. Facultad de Ciencias de la Salud. Campus Vegazana, s/n 24071 León

Country

Spain

Phone

+34650092601

Fax

imunoz30493@gmail.com

Contact person for scientific queries

Name

Ines muñoz Paredes

Address

University of Leon. AV. Facultad de Ciencias de la Salud. Campus Vegazana, s/n 24071 León

Country

Spain

Phone

+34650092601

Fax

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

Source	Title	Year of Publication	DOI
Embase	The Effect of Combining Transcranial Direct Current Stimulation Treatment and an Exercise Program on Fragility in a Population with Multiple Sclerosis: Cross-Over Design Trial.	2022	https://dx.doi.org/10.3390/ijerph191912747

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically