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 |
| Protocol serial number | 01 044 03 |
| Sponsor | Caisse Nationale d'Assurance Maladie des Travailleurs Salaries (CNAMT) (France) |
| Funder | Caisse Nationale d'Assurance Maladie des Travailleurs Salaries (CNAMT) (France) - CNAMT-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
Scientific
170 Avenue de Casselardit
Toulouse
31100
France
| yvesmrolland@yahoo.fr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | That 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) studied | 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 |
| Primary outcome measure(s) |
The primary efficacy outcome was decline from baseline in Katz Index ADL score compared with the control group at 12 months of follow-up. |
| Key secondary outcome measure(s) |
The secondary efficacy outcomes included measures of physical performance, nutritional status, behavioral disturbance and depression. |
| Completion date | 01/02/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 150 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/02/2004 |
| Date of final enrolment | 01/02/2005 |
Locations
Countries of recruitment
- France
Study participating centre
170 Avenue de Casselardit
Toulouse
31100
France
31100
France
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
