Effectiveness of physical training in persons with mild to moderate cognitive impairment: a randomised controlled trial
| ISRCTN | ISRCTN49243245 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49243245 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/12/2006
- Registration date
- 26/01/2007
- Last edited
- 16/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Klaus Hauer
Scientific
Scientific
Geriatric Research Department
Bethanien-Krankenhaus at the University of Heidelberg
Rohrbacherstr 149
Heidelberg
069126
Germany
Study information
| Study design | Randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | A standardised training regimen of progressive resistance and functional training will improve strength and functional performance (primary outcomes) and cognitive and emotional status, risk of falling and activity level (secondary outcomes) in persons with mild to moderate cognitive impairment. |
| Ethics approval(s) | Ethical Committee of the Medical Faculty of the University of Heidelberg, 28/11/2005, application number: 255/2005 |
| Health condition(s) or problem(s) studied | Motor, cognitive, emotional, physical activity status, risk of falling in persons with cognitive impairment |
| Intervention | Intervention group: Individually tailored progressive resistance and functional training including attentional demands in supervised training group twice/week (two hours) for 12 weeks. Control group: Group training of non relevant motor dimension (basically stretching exercise) while seated twice/week (one hour) for twelve weeks. |
| Intervention type | Other |
| Primary outcome measure | Maximal strength and functional performance. All measurements assessed at baseline, three months, six months, and 12 months by validated, established evaluation tools. |
| Secondary outcome measures | 1. Emotional and cognitive status 2. Physical activity level 3. Risk of falling |
| Overall study start date | 01/04/2006 |
| Completion date | 01/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Aged over 65 2. No severe or uncontrolled somatic or psychological disease 3. Mini Mental State Examination (MMSE) score 15 to 26 4. Ability to walk 5 metres with assistance 5. Residence within 15 km of study centre 6. Written informed consent 7. No severe language restriction 8. No severe visual deficits |
| Key exclusion criteria | Not applicable |
| Date of first enrolment | 01/04/2006 |
| Date of final enrolment | 01/09/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Geriatric Research Department
Heidelberg
069126
Germany
069126
Germany
Sponsor information
Landesstiftung Baden Württemberg (Germany)
Research organisation
Research organisation
Im Kaisemer 1
Stuttgart
70191
Germany
| Website | http://www.landesstiftung-bw.de |
|---|---|
"ROR" |
https://ror.org/031h5fa94 |
Funders
Funder type
Research organisation
Landesstiftung Baden-Württemberg (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 12/06/2014 | Yes | No |
