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
Contact information
Prof Heinz Mechling
Scientific
Scientific
Am Sportpark Müngersdorf 6
Cologne
50933
Germany
| Phone | +49 (0)221 4982 6149 |
|---|---|
| mechling@dshs-koeln.de |
Study information
| Study design | Two arms 3 phase multicentre block randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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? |
| Study acronym | NADiA |
| Study objectives | 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(s) | Ethics committee of the German Sport University Cologne, approved on 26/05/2009 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/04/2010 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 participants; 100 patients, each together with one family member carer. |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2010 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- Germany
Study participating centre
Am Sportpark Müngersdorf 6
Cologne
50933
Germany
50933
Germany
Sponsor information
Institute of Sport Gerontology, German Sport University Cologne (Germany)
University/education
University/education
Am Sportpark Müngersdorf 6
Cologne
50933
Germany
| Phone | +49 (0)221 4982 6142 |
|---|---|
| f.nieder@dshs-koeln.de | |
"ROR" |
https://ror.org/0189raq88 |
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
