Exercise Program in Nursing Home Residents with Alzheimer's disease (AD). A One-Year Randomized Controlled Trial.

ISRCTN ISRCTN72013235
DOI https://doi.org/10.1186/ISRCTN72013235
Secondary identifying numbers 01 044 03
Submission date
06/12/2005
Registration date
20/12/2005
Last edited
10/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Yves Rolland
Scientific

170 Avenue de Casselardit
Toulouse
31100
France

Email yvesmrolland@yahoo.fr

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesThat there is a benefit in activities of daily living (ADL) in patients with Alzheimers disease undergoing a regular exercise programme.
Ethics approval(s)Institutional Review Boards of Toulouse
Health condition(s) or problem(s) studiedAlzheimer's Disease
InterventionThe intervention group received a regular exercise programme.
The control group received normal medical care but no regular exercise programme.
Intervention typeOther
Primary outcome measureThe 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 measuresThe secondary efficacy outcomes included measures of physical performance, nutritional status, behavioral disturbance and depression.
Overall study start date01/02/2004
Completion date01/02/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants150
Key inclusion criteria1. 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.
Key exclusion criteria1. 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
Date of first enrolment01/02/2004
Date of final enrolment01/02/2005

Locations

Countries of recruitment

  • France

Study participating centre

170 Avenue de Casselardit
Toulouse
31100
France

Sponsor information

Caisse Nationale d'Assurance Maladie des Travailleurs Salaries (CNAMT) (France)
Government

50 Avenue du Professeur André Lemierre
Paris
75986
France

Phone +33 (0)1 72 60 10 00
Email info@ameli.fr

Funders

Funder type

Government

Caisse Nationale d'Assurance Maladie des Travailleurs Salaries (CNAMT) (France) - CNAMT-01 044 03

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2007 Yes No