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

ISRCTN	ISRCTN87391496
DOI	https://doi.org/10.1186/ISRCTN87391496
Protocol serial number	LT-DEMENZ-44-059
Sponsor	German Federal Ministry of Health (Bundesministerium fur Gesundheit [BMG]) (Germany)
Funder	German Federal Ministry of Health (Bundesministerium fur Gesundheit [BMG]) (Germany) (ref: LT Demenz 44-059)

Submission date: 27/11/2008
Registration date: 16/01/2009
Last edited: 12/12/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Elmar Gräßel
Scientific

University Hospital Erlangen
Clinic for Psychiatry and Psychotherapy
Schwabachanlage 6
Erlangen
91054
Germany

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled single-blind intervention study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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)
Study acronym	MAKS aktiv!
Study objectives	Principal aim of the study: To prove the effectiveness of an intensive intervention consisting of everyday activities, cognitive, motor and exercise elements on dementia patients' cognitive and activities of daily living (ADL) capacities in five nursing homes. Principal hypothesis: In the 6 months observation period the multi-modal activating therapy results in significantly better cognitive and ADL capacities within the intervention group compared to the control group in the way that the capacities of the intervention group remain on average on their initial level, whereas the control groups' capacities decrease according to the disease's progression. As of 30/07/09 this trial has been updated. Please note that recruitment for this trial has been completed. Patients wishing to learn more about the trial may use the contact details below to request more information or get informed at the trial's official website http://www.maks-aktiv.de
Ethics approval(s)	Ethics committee of the Faculty of Medicine of the University Erlangen Nuremberg gave approval on 10th July 2008 (ref: 3232)
Health condition(s) or problem(s) studied	Dementia
Intervention	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, for at least six months. Control: Standard care (no changes in the care situation). Baseline data (t0) is collected directly before the 6 months intervention period. After the 6 months the first follow up outcome data (t1) is collected. Further follow ups are planned at 1.5 and 2.5 years after t1. This design is equivalent for all treatment arms (intervention and control group).
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/11/2009

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	135
Key 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
Key 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
Date of first enrolment	01/09/2008
Date of final enrolment	30/11/2009

Locations

Countries of recruitment

Germany

Study participating centre

University Hospital Erlangen

Erlangen
91054
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2012		Yes	No
Results article	follow-up results	05/12/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes