Effects of a physical exercise program on daily living activities in dementia
| ISRCTN | ISRCTN86442281 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86442281 |
| Protocol serial number | 13DPD6_134852 |
| Sponsor | University of Applied Sciences Western Switzerland (Switzerland) |
| Funders | The Swiss National Science Foundation [National Suisse de la Recherche (FNS-SNF)] (Switzerland) - Programme DoRe, Ref: 13DPD6_129863, Swiss Alzheimer Association [Association Alzheimer Suisse] (Switzerland), University of Applied Sciences Western Switzerland (Switzerland), University Hospital Vaudois [Centre Hospitalier Universitaire Vaudois] (Switzerland), Fribourg Research Network of Mental Health [Réseau Fribourgeois de Santé Mentale] (Switzerland) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter randomized controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
1. Independence in activities of daily living (ADL), measured with the Barthel index at baseline, 4 weeks and 6 weeks |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/11/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/01/2019: Publication reference added
