Condition category
Mental and Behavioural Disorders
Date applied
27/08/2012
Date assigned
04/09/2012
Last edited
19/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients with dementia suffer from motor as well as cognitive impairment. Motor impairment is a major cause of physical disability and includes muscle weakness and fatigue, impaired sensation and poor balance. Cognitive impairment is when a person has trouble remembering, learning new things, concentrating, or making decisions that affect their everyday life. Based on successful previous studies we have developed a specific training programme to improve cognitive and motor defects which are frequent and early markers of dementia (problems with doing two things at once and planning and performing movements). We use supervised group training and a machine-based approach specifically developed for the patients with mild to moderate dementia

Who can participate?
Patients over 65 with mild to moderate dementia.

What does the study involve?
Participants will be randomly allocated to one of two training programs: either an established training program for older persons (strength and flexibility training), or a specific training program developed to achieve better cognitive/motor performance. Participants will be encouraged to attend two supervised exercise sessions per week for 3 months.

What are the possible benefits and risks of participating?
The specific training will hopefully lead to improved cognitive performance. The risks are low - we expect only harmless effects of training (e.g. getting a little out of breath) as the training intensity is individually tailored and supervised by experienced trainers.

Where is the study run from?
The Bethanien Hospital, Geriatric Center at the University of Heidelberg (Germany).

When is the study starting and how long is it expected to run for?
The study will start in September 2012 and will proceed until June 2014.

Who is funding the study?
The Dietmar Hopp Foundation (Germany).

Who is the main contact?
Prof Klaus Hauer
khauer@bethanien-heidelberg.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Klaus Hauer

ORCID ID

Contact details

University of Heidelberg
Bethanien Hospital Geriatric Centre
Rohrbacherstraße 149
Heidelberg
69126
Germany
+49-6221-3191532
khauer@bethanien-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

The dementia-specific training approach will increase dual task performances and executive functions and effect a number of secondary study targets in patients with mild to moderate stage dementia.

Ethics approval

University of Heidelberg, Faculty of Medicine Ethics Committee, May 2012, ref: S-360/2010

Study design

Blinded randomised placebo-controlled interventional single centered study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mild to moderate stage, diagnostically confirmed dementia

Intervention

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 attend two supervised exercise sessions per week for 1.5 hours for 3 months.

Control Group (CG) will receive unspecific motor training (calistenics and strength training of upper extremities while seated). Subjects will be encouraged to attend two supervised exercise sessions per week for 1 hours for 3 months.

Both study groups will be treated by patient-centered training approach tailored to the needs and abilities of cognitively impaired patients as developed and described by the working group in previous intervention trials for patients with dementia.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

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 outcome measures

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)

Overall trial start date

01/09/2012

Overall trial end date

30/06/2014

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

The target number for participants to achieve a significant effect on primary endpoint dual task performances: 92; for executive functions: <92.

Participant exclusion criteria

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

Recruitment start date

01/09/2012

Recruitment end date

30/06/2014

Locations

Countries of recruitment

Germany

Trial participating centre

University of Heidelberg
Heidelberg
69126
Germany

Sponsor information

Organisation

Dietmar Hopp Foundation (Germany)

Sponsor details

[Dietmar Hopp Stiftung]
Raiffeisenstraße 51
St. Leon Rot
68789
Germany

Sponsor type

Charity

Website

http://www.dietmar-hopp-stiftung.de

Funders

Funder type

Charity

Funder name

Dietmar Hopp Foundation (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes