Contact information
Type
Scientific
Primary contact
Dr Yves Rolland
ORCID ID
Contact details
170 Avenue de Casselardit
Toulouse
31100
France
yvesmrolland@yahoo.fr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01 044 03
Study information
Scientific title
Acronym
Study hypothesis
That there is a benefit in activities of daily living (ADL) in patients with Alzheimers disease undergoing a regular exercise programme.
Ethics approval
Institutional Review Boards of Toulouse
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Alzheimer's Disease
Intervention
The intervention group received a regular exercise programme.
The control group received normal medical care but no regular exercise programme.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary efficacy outcome was decline from baseline in Katz Index ADL score compared with the control group at 12 months of follow-up.
Secondary outcome measures
The secondary efficacy outcomes included measures of physical performance, nutritional status, behavioral disturbance and depression.
Overall trial start date
01/02/2004
Overall trial end date
01/02/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. To have met the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer Disease and Related Disorders Association criteria for probable or possible AD
2. To have lived in the nursing-home for at least 2 months
3. To be able to transfer from a chair and walk for at least 6 meters without human assistance
4. To have a Mini-Mental State Examination (MMSE) score <25
Enrolment lasted two weeks.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Evidence of vascular dementia or Parkinson disease
2. Planned transfer from the nursing home or surgery in the year to come
3. A cardiac condition that might deteriorate during exercise, such as unstable angina or severe congestive heart disease
4. Diagnosis of a terminal illness with a life expectancy less than 6 months
Recruitment start date
01/02/2004
Recruitment end date
01/02/2005
Locations
Countries of recruitment
France
Trial participating centre
170 Avenue de Casselardit
Toulouse
31100
France
Sponsor information
Organisation
Caisse Nationale d'Assurance Maladie des Travailleurs Salaries (CNAMT) (France)
Sponsor details
50 Avenue du Professeur André Lemierre
Paris
75986
France
+33 (0)1 72 60 10 00
info@ameli.fr
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Caisse Nationale d'Assurance Maladie des Travailleurs Salaries (CNAMT) (France) - CNAMT-01 044 03
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
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17302650
Publication citations
-
Results
Rolland Y, Pillard F, Klapouszczak A, Reynish E, Thomas D, Andrieu S, Rivière D, Vellas B, Exercise program for nursing home residents with Alzheimer's disease: a 1-year randomized, controlled trial., J Am Geriatr Soc, 2007, 55, 2, 158-165, doi: 10.1111/j.1532-5415.2007.01035.x.