Contact information
Type
Scientific
Primary contact
Dr Nicolas Kuhne
ORCID ID
Contact details
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
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13DPD6_134852
Study information
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
Acronym
Study hypothesis
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
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
Study design
Multicenter randomized controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
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. 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
Phase
Not Applicable
Drug names
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 trial start date
01/06/2011
Overall trial end date
30/11/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
240
Participant 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
Recruitment start date
01/06/2011
Recruitment end date
30/11/2012
Locations
Countries of recruitment
Switzerland
Trial participating centre
University of Applied Sciences Western Switzerland
Carouge
1227
Switzerland
Sponsor information
Organisation
University of Applied Sciences Western Switzerland (Switzerland)
Sponsor details
Rue de la Jeunesse 1
Delémont
2800
Switzerland
-
info@hes-so.ch
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
The Swiss National Science Foundation [National Suisse de la Recherche (FNS-SNF)] (Switzerland) - Programme DoRe, Ref: 13DPD6_129863
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Swiss Alzheimer Association [Association Alzheimer Suisse] (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Applied Sciences Western Switzerland (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University Hospital Vaudois [Centre Hospitalier Universitaire Vaudois] (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Fribourg Research Network of Mental Health [Réseau Fribourgeois de Santé Mentale] (Switzerland)
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
Basic results (scientific)
Publication list
1. 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27831462 (added 29/01/2019)