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van CCT (UK)

van CCT (UK)

Brain mechanisms of balance learning in aging

- candidate number28299
- NTR NumberNTR6861
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-dec-2017
- Secondary IDs201700861 NL64147.041.17
- Public TitleBrain mechanisms of balance learning in aging
- Scientific TitleBrain mechanisms of balance leaning in aging
- hypothesisThe overall hypothesis is that balance-specific exercise training only improves postural control of sway measured in standing and causes retention of the improved sway behavior and that such behavioral improvements correlate with changes in measures of neuronal excitability in the brain.
- Healt Condition(s) or Problem(s) studiedAging
- Inclusion criteriaYoung adults: Age between 18 and 40, female or male, healthy. Old adults: Age between 65 and 85, female or male, healthy.
- Exclusion criteriaA score lower than 24 on the Mini Mental State Examination
A score higher than 70 on the falls self-efficacy scale
More than 1 fall over the past year (‘Coming unintentionally to rest on the ground, floor, or lower level’)
Do not meet TMS guidelines
Unable to stand independently for 10 minutes without rest
Any metal in the brain/skull
Electrical, magnetic, or mechanical implantation: cardiac pacemakers or intracerebral vascular clip
Pregnancy or suspicion of pregnancy
History of seizures or unexplained loss of consciousness
Immediate family member with epilepsy
Use of seizure threshold lowering medicine
History of Schizophrenia
History of Hallucinations
History of other neurological disorders
A prior stroke, heart attack, heart failure, bypass, cardiac arhythmia Acute flu or cold
Spinal, joint, and head pain
Diabetes mellitus
Hypertension (systolic/diastolic > 160/ > 100 mmHg)
Acute and chronic inflammatory condition
Severe arthrosis
Knee or hip endoprosthesis
Trauma within the last 6 months
Active cancer, cancer therapy
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2018
- planned closingdate1-feb-2022
- Target number of participants288
- InterventionsBalance training on an unstable surface, cycling on an a stationary bicycle ergometer and no-intervention control
- Primary outcomeBehavioral outcome during balance learning is the error produced by balancing on an unstable balance board (Sensamove, Groessen, NL). The error, in degrees, is computed as the cumulative deviation between the position of the board relative to the horizontal. In addition to the performance on the balance board, the laboratory behavioral outcome is the magnitude of sway on the force platform measured in standing with a narrow stance during TMS and EEG testing. Magnitude of sway is expressed in cm as path length over unit time and the velocity of sway in the anterior-posterior and in the medio- lateral directions.
- Secondary outcomeTMS outcomes include the size of the short-interval intracortical inhibition (SICI), long- interval intracortical inhibition (LICI), and corticospinal excitability measured as the amplitude of the motor evoked potential (MEP). EEG outcomes include the phase slope index, a measure of connectivity in the frequency domain between specific brain areas.
- Timepointsacute study: week 1
Chronic study: week 1, week 4 and week 6
- Trial web site
- statusplanned
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD5-dec-2017 - 14-dec-2017

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