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MAKS aktiv! Multi-modal activating therapy for dementia patients in nursing homes (activating therapy concerning everyday activities, exercise, cognitive and spiritual elements)

Multi-modal activating therapy for dementia patients in nursing homes: a randomised controlled trial with an intervention group (standard care plus non-pharmacological activating therapy) and a control group (standard care)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87391496
Enrollment
135
Registered
2009-01-16
Start date
2008-09-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Dementia Mental and Behavioural Disorders Unspecified dementia

Interventions

Intervention: Multi-modal activating therapy, consisting of everyday activities, exercise, cognitive and spiritual elements, in five groups of ten persons each, two hours per day, six days per week,

Sponsors

German Federal Ministry of Health (Bundesministerium fur Gesundheit [BMG]) (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 102 inhabitants of 5 nursing homes in Germany: 1. Existence of an degenerative dementia syndrome (diagnosed by a physician according to International Classification of Diseases, version 10 [ICD-10]) 2. Mini-Mental State Examination (MMSE): value less than 24 points 3. Level of care of 0, 1 or 2 (not 3) according to the criteria of the German Health Insurance companies 4. Existence of an informed consent of the patient or his/her legal guardian

Exclusion criteria

Exclusion criteria: 1. Psychiatric-neurological disease other than dementia that explains the cognitive impairment (e.g. schizophrenia) 2. Purely vascular dementia (diagnosed by physician) 3. Level of care equals 3 4. Blindness 5. Deafness 6. Being bed-ridden 7. Other severe obstacle for participating in the intervention group

Design outcomes

Primary

MeasureTime frame
1. Competences in activities of daily living (ADL) operationalised with the Erlangen Test of Activities of Daily Living (E-ADL Test); score (0 = no ADL function, 30 = normal ADL function) 2. Cognitive abilities operationalised with the cognitive subtest of the Alzheimer's Disease Assessment Scale (ADAS-kog); score (0 = no cognitive impairment, 70 = severe impairment) Primary and secondary outcome measures are collected for every participant individually in the week before (t0) and after (t1) the six months intervention period. For most of the participants the first measurements is from 20th to 31st October (t0) and again from 4th to 15th of May (t1). Participants who join the project at a later date to replace another participant who had to be excluded will have their t0 in the months of November 2008 until May 2009 and their t1 six months later, at the latest in November 2009.

Secondary

MeasureTime frame
1. Instrumental Activities of Daily Living (IADL) operationalised with the subscale IADL of the Nurses Observation Scale for Geriatric Patients (NOSGER); score (5 = full IADL function, 25 = no IADL function) 2. Global geriatric symptomatology operationalised with the NOSGER cumulative value; score (30 = no impairment, 150 = severe impairment) 3. Level of nursing care dependency operationalised with the level of care according to the criteria of the German Health Insurance companies (no level of care = no care necessary, level 3 = highest level of care) and the Barthel-Index; score (0 = total care dependence, 100 = independent) 4. Care requirements and time cost operationalised with the Resource Utilisation in Dementia (RUD), items for ADL, IADL and supervision; score (time in minutes per day) Primary and secondary outcome measures are collected for every participant individually in the week before (t0) and after (t1) the six months intervention period. For most of the participants the first measurements is from 20th to 31st October (t0) and again from 4th to 15th of May (t1). Participants who join the project at a later date to replace another participant who had to be excluded will have their t0 in the months of November 2008 until May 2009 and their t1 six months later, at the latest in November 2009.

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 27, 2026