Condition category
Mental and Behavioural Disorders
Date applied
06/12/2006
Date assigned
26/01/2007
Last edited
16/06/2014
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 Klaus Hauer

ORCID ID

Contact details

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

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

http://www.landesstiftung-bw.de

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

  1. 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.

Additional files

Editorial Notes