Effects of a physical exercise program on daily living activities in dementia
| ISRCTN | ISRCTN86442281 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86442281 |
| Secondary identifying numbers | 13DPD6_134852 |
- Submission date
- 13/04/2011
- Registration date
- 22/06/2011
- Last edited
- 29/01/2019
- 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
Dr Nicolas Kuhne
Scientific
Scientific
University of Applied Sciences and Arts Western Switzerland
Occupational Therapy Department
Haute Ecole de Santé - Genève
25 Rue des Caroubiers
Carouge
1227
Switzerland
| nkuhne@gmail.com |
Study information
| Study design | Multicenter randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| 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 | Effects of a physical exercise program on performance in activity of daily living (ADL) on acute hospitalized elderly patients with moderate to severe dementia: a multicenter, randomized, controlled trial |
| Study objectives | In addition to usual care, a physical exercise program of 20 group sessions is effective in maintaining or improving activity of daily living performance in acute hospitalized elderly with moderate to severe dementia, as opposed to a control group receiving only regular care and social activities of the same duration as the intervention group |
| Ethics approval(s) | Cantonal Ethics Committee for Research on Humans (Etat de Vaud, Commission Cantonale d'éthique de la Recherche sur l'être Humain) approved on 27/01/2011, Ref: 250/08 |
| Health condition(s) or problem(s) studied | Dementia |
| Intervention | 1. Gradually increasing physical exercise program (20 group sessions of 30 minutes over 4 weeks) covering aerobic, strength, flexibility and balance training 2. Accompanied by music Control group: social activities of the same form, frequency and duration as intervention group. |
| Intervention type | Other |
| Primary outcome measure | 1. Independence in activities of daily living (ADL), measured with the Barthel index at baseline, 4 weeks and 6 weeks 2. The Functional Independence Measure (FIM) |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/06/2011 |
| Completion date | 30/11/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 240 |
| Key inclusion criteria | 1. Informed consent 2. Patients over 65 years 3. Hopitalized in a acute psychiatric hospital 4. With dementia according to CIM-10 classification 5. With moderate or severe dementia according to CDR scores (clinical dementia rating of 2 or more) 6. Able to walk at least 6 meters, if necessary with assistance |
| Key exclusion criteria | 1. Patient for whom a physical exercise program represents a risk 2. Life expectancy estimated less than 4 weeks 3. Hospital stay estimated to be less than 6 weeks 4. Musculoskeletal conditions which do not permit the application of the physical exercise program 5. Recent hemiplegia (< 4 weeks) 6. Somatic or psychiatric trouble requiring intensive care |
| Date of first enrolment | 01/06/2011 |
| Date of final enrolment | 30/11/2012 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
University of Applied Sciences Western Switzerland
Carouge
1227
Switzerland
1227
Switzerland
Sponsor information
University of Applied Sciences Western Switzerland (Switzerland)
University/education
University/education
Rue de la Jeunesse 1
Delémont
2800
Switzerland
| info@hes-so.ch | |
| Website | http://www.hes-so.ch |
"ROR" |
https://ror.org/01xkakk17 |
Funders
Funder type
Government
The Swiss National Science Foundation [National Suisse de la Recherche (FNS-SNF)] (Switzerland) - Programme DoRe, Ref: 13DPD6_129863
No information available
Swiss Alzheimer Association [Association Alzheimer Suisse] (Switzerland)
No information available
University of Applied Sciences Western Switzerland (Switzerland)
No information available
University Hospital Vaudois [Centre Hospitalier Universitaire Vaudois] (Switzerland)
No information available
Fribourg Research Network of Mental Health [Réseau Fribourgeois de Santé Mentale] (Switzerland)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2017 | 29/01/2019 | Yes | No |
Editorial Notes
29/01/2019: Publication reference added
