New activity choices for patients with dementia and their family member carers - establishment and evaluation of the “Fit for 100” training as a new support program. [Neue Aktionsräume für menschen mit Demenz und ihre Angehörigen - NADiA]

ISRCTN ISRCTN99589829
DOI https://doi.org/10.1186/ISRCTN99589829
Secondary identifying numbers 24.17.01-62-V42A-3372
Submission date
24/03/2011
Registration date
04/05/2011
Last edited
01/05/2013
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
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Heinz Mechling
Scientific

Am Sportpark Müngersdorf 6
Cologne
50933
Germany

+49 (0)221 4982 6149
mechling@dshs-koeln.de

Study information

Study designTwo arms 3 phase multicentre block randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleJoint 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?
Study acronymNADiA
Study objectivesA 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(s)Ethics committee of the German Sport University Cologne, approved on 26/05/2009
Health condition(s) or problem(s) studiedDementia
Intervention1. 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 typeOther
Primary outcome measure1. Burden Scale for Family Carergivers (BSFC)
2. Functional independence measure plus functional assessment measure, UK FIM+FAM
Secondary outcome measures1. 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 study start date01/04/2010
Completion date31/12/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants200 participants; 100 patients, each together with one family member carer.
Key inclusion criteriaPatients:
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
Key exclusion criteriaPatients:
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
Date of first enrolment01/04/2010
Date of final enrolment31/12/2013

Locations

Countries of recruitment

  • Germany

Study participating centre

Am Sportpark Müngersdorf 6
Cologne
50933
Germany

Sponsor information

Funders

Funder type

Government

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

No information available

Equalisation fund of the public long-term care insurance

No information available

German Sport University Cologne (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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