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
Protocol serial number	N/A
Sponsor	Landesstiftung Baden Württemberg (Germany)
Funder	Landesstiftung Baden-Württemberg (Germany)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Klaus Hauer
Scientific

Geriatric Research Department
Bethanien-Krankenhaus at the University of Heidelberg
Rohrbacherstr 149
Heidelberg
069126
Germany

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
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(s)	Maximal strength and functional performance. All measurements assessed at baseline, three months, six months, and 12 months by validated, established evaluation tools.
Key secondary outcome measure(s)	1. Emotional and cognitive status 2. Physical activity level 3. Risk of falling
Completion date	01/09/2009

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Target sample size at registration	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

Geriatric Research Department

Heidelberg
069126
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	12/06/2014		Yes	No