Condition category
Mental and Behavioural Disorders
Date applied
13/04/2011
Date assigned
22/06/2011
Last edited
03/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Elisabeth Bürge

ORCID ID

Contact details

University of Applied Sciences Western Switzerland
Department of Physiotherapy
Haute Ecole de Santé - Genève
25 Rue des Caroubiers
Carouge
1227
Switzerland
elisabeth.burge@hesge.ch

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 measures

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

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

http://www.hes-so.ch

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes