Skip to content

Effectiveness of the application of a TDCs treatment and combined exercise program on fragility in a population wtih Multiple Sclerosis

Effectiveness of the application of a TDCs treatment and combined exercise program on fragility in a population wtih Multiple Sclerosis

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000264785
Enrollment
15
Registered
2022-02-14
Start date
2020-03-02
Completion date
2020-09-01
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Leon University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 9, 2026