Condition category
Nervous System Diseases
Date applied
06/12/2005
Date assigned
20/12/2005
Last edited
10/09/2009
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

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

  1. 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.

Additional files

Editorial Notes