Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Ethical Committee of the Medical Faculty of the University of Heidelberg, 28/11/2005, application number: 255/2005
Study design
Randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/04/2006
Overall trial end date
01/09/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
120
Participant exclusion criteria
Not applicable
Recruitment start date
01/04/2006
Recruitment end date
01/09/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Geriatric Research Department
Heidelberg
069126
Germany
Sponsor information
Organisation
Landesstiftung Baden Württemberg (Germany)
Sponsor details
Im Kaisemer 1
Stuttgart
70191
Germany
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Landesstiftung Baden-Württemberg (Germany)
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24924703
Publication citations
-
Results
Schwenk M, Zieschang T, Englert S, Grewal G, Najafi B, Hauer K, Improvements in gait characteristics after intensive resistance and functional training in people with dementia: a randomised controlled trial., BMC Geriatr, 2014, 14, 73, doi: 10.1186/1471-2318-14-73.