Evaluation of a dementia-specific training in patients with mild to moderate-stage dementia

Evaluation of a dementia-specific training in patients with mild to moderate-stage dementia: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN37232817

Enrollment

Registered

2012-09-04

Start date

2012-09-01

Completion date

Unknown

Last updated

2018-12-10

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

Conditions

Mild to moderate stage, diagnostically confirmed dementia Mental and Behavioural Disorders Unspecified dementia

Interventions

Intervention Group (IG) will receive specific motor-cognitive training (dual tasking/ executive function) including individual machine-based motor-cognitive training. Subjects will be encouraged to a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >65 2. Mild to moderate stage cognitive impairment (MMSE:17-26) 3. Diagnosis of mild to moderate stage dementia based on established international criteria 4. Written informed consent 5. Consent of legal guardian (if assigned) 6. Ability to walk 10 m without aid 7. Living in the vicinity of the study location (<20 km)

Exclusion criteria

Exclusion criteria: 1. Severe psychical disease (substance abuse, psychosis) 2. Severe somatic disease (e.g. heart failure NYHA >3, uncontrolled Diabetes Mellitus)

Design outcomes

Primary

Measure	Time frame
Improvement of dual task performance (trained and non-trained tasks as measured by electronic gait (Gait rite) and strength analysis (Diagnos 40) and specified cognitive tests) and executive function as measured by biomechanical analyses (DynaPort Hybrid and Physiomat training device) after intervention.	—

Secondary

Measure	Time frame
1. MRI-Assessment: 1.1. Association of training induced cerebral modifications with training effects and baseline predictors 1.2. Dual task during ADL: Effect of specific training on habitual dual task performance/frequency as measured in home environment 2. Physical activity: Physical activity as measured by valid, subjective questionnaire-based measures and objective technical measures allowing quantitative and semi-quantitative analysis optionally including GPs measures 3. Motor Function: 3.1. Timed up and Go - Test 3.2. Performance Oriented Motor Assessment (POMA) 3.3. Psychological / Cognitive Status: Fear of Falling (FESI) 3.4. Geriatric Depression Scale (GDS) 3.5. Short Form Health Survey (SF-12) 3.6. Consortium to establish a registry for Alzheimer´s disease (CERAD) Trial making test (Zahlenverbindungstest (ZVT), Digit Span test (Zahlennachsprechtest (ZNS), and various other measures. Validation of assessment tools: Tests for methodological quality of assessment methods including validity, reliability, sensivity to change. Optional: Biomarkers: Association of training effects with biomarkers for neural plasticity Primary as well as secondary outcome measures will be assessed at baseline (T1), at the end of intervention (T2) and at a 3 months follow up (T3)	—

Measure

Time frame

1. MRI-Assessment: 1.1. Association of training induced cerebral modifications with training effects and baseline predictors 1.2. Dual task during ADL: Effect of specific training on habitual dual task performance/frequency as measured in home environment 2. Physical activity: Physical activity as measured by valid, subjective questionnaire-based measures and objective technical measures allowing quantitative and semi-quantitative analysis optionally including GPs measures 3. Motor Function: 3.1. Timed up and Go - Test 3.2. Performance Oriented Motor Assessment (POMA) 3.3. Psychological / Cognitive Status: Fear of Falling (FESI) 3.4. Geriatric Depression Scale (GDS) 3.5. Short Form Health Survey (SF-12) 3.6. Consortium to establish a registry for Alzheimer´s disease (CERAD) Trial making test (Zahlenverbindungstest (ZVT), Digit Span test (Zahlennachsprechtest (ZNS), and various other measures. Validation of assessment tools: Tests for methodological quality of assessment methods including validity, reliability, sensivity to change. Optional: Biomarkers: Association of training effects with biomarkers for neural plasticity Primary as well as secondary outcome measures will be assessed at baseline (T1), at the end of intervention (T2) and at a 3 months follow up (T3)

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026