Condition category
Mental and Behavioural Disorders
Date applied
24/03/2011
Date assigned
04/05/2011
Last edited
01/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.nadia-projekt.de

Contact information

Type

Scientific

Primary contact

Prof Heinz Mechling

ORCID ID

Contact details

Am Sportpark Müngersdorf 6
Cologne
50933
Germany
+49 (0)221 4982 6149
mechling@dshs-koeln.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

24.17.01-62-V42A-3372

Study information

Scientific title

Joint physical exercise with elderly patients with dementia and their family member carers in a two arm block randomized controlled trial: Does the "Fit for 100" training program support functional independence and help to decrease burden of care at the same time?

Acronym

NADiA

Study hypothesis

A new strength training programme has been developed in accordance to modern training principles and has been proved feasible for the elderly (ISRCTN55213782). The main question is now, whether the new programme can counteract or prevent the strength decline of patients with dementia and at the same time ease the physical capacity of their family member carers (FMC), who as a general rule belong to the elderly target group themselves.

Hypothesis: In comparison to the control group, the training programme increases
1. Physical capacity
2. Activities of daily living in the patients with dementia

The family member carers can achieve:
1. An increase in physical capacity
2. A decrease in the burden of home care

Please note that as of 01/05/2013, the anticipated end date of this trial was updated from 31/03/2013 to 31/12/2013

Ethics approval

Ethics committee of the German Sport University Cologne, approved on 26/05/2009

Study design

Two arms 3 phase multicentre block randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

Dementia

Intervention

1. 12 week learning and 12 week strength exercise phase for intervention group
2. 12 week control phase + 12 week learning phase + 12 week strength exercise phase for control group
3. The exercise programme has been described in another trial (ISRCTN55213782)
4. It contains ten resistance exercises, covering muscle groups necessary for everyday movements, carried out in a slow, controlled manner
5. One or two series, ten repetitions per set, intensity about 80% of 1 repitition max
6. Exercise programme 2x60min/week over at least 24 weeks in a joint group for both the patient and family carer
7. General activation programme (social, cognitive) 2x60min/week from week 1 to week 12 in a joint group for both the patient and family carer
8. Afterwards the exercise programme 2x60min/week over 12 weeks will be offered compensatory

Scientific contact details:
Dr. Michael Brach
University Muenster, Institute of Sport Science
Horstmarer Landweg 62b, 48149 Muenster
phone: +49 251 83 32326, Fax: +49 251 83 32303
email: michael.brach@wwu.de

Dr. Sabine Eichberg
Institut für Bewegungs- und Sportgerontologie, Deutsche Sporthochschule Köln
Am Sportpark Müngersdorf 6, 50933 Köln
phone: +49 221 4982-6145, Fax: +49 221 4982-6143
email: eichberg@dshs-koeln.de

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Burden Scale for Family Carergivers (BSFC)
2. Functional independence measure plus functional assessment measure, UK FIM+FAM

Secondary outcome measures

1. Cognitive ability using the Mini Mental State Examination, MMSE, (German version - MMST)
2. Activities of daily living (ADL) - Barthel Index & Instrumental Activities of Daily Living (IADL)
2.1. Timed "up and go"
2.2. Physical ability - hand grip force
2.3. Chair stand test - standing on a force plate in different foot positions (parallel, semi.tandem, tandem)
2.4. Shoulder flexibility
2.5. Hand-eye coordination test
2.6. Actual quantity of motor activity in five categories, using a tridimensional accelerometer
2.7. Daily movement questionnaire

Overall trial start date

01/04/2010

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Patients:
1. Diagnosed dementia
2. Ability to stand
3. Ability to work in groups
4. Written informed consent (acclamation by custodian)

Family member carers:
1. Willing to accompany the patient
2. Willing to participate in joint training

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 participants; 100 patients, each together with one family member carer.

Participant exclusion criteria

Patients:
1. Mini mental state examination (MMSE) lower than 10
2. MMSE between 10 and 15 and Barthel-Index lower than 60.
3. For both groups: disapproval by the attending doctor

Recruitment start date

01/04/2010

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Germany

Trial participating centre

Am Sportpark Müngersdorf 6
Cologne
50933
Germany

Sponsor information

Organisation

Institute of Sport Gerontology, German Sport University Cologne (Germany)

Sponsor details

Am Sportpark Müngersdorf 6
Cologne
50933
Germany
+49 (0)221 4982 6142
f.nieder@dshs-koeln.de

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Ministry of Work, Health and Social Affairs of the state North-Rhine Westphalia (Germany) (ref.: 24.17.01-62-V42A-3372)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Equalisation fund of the public long-term care insurance

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

German Sport University Cologne (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