Condition category
Nervous System Diseases
Date applied
08/12/2008
Date assigned
05/02/2009
Last edited
05/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ibusg.de/index.php?page=mokog

Contact information

Type

Scientific

Primary contact

Prof Heinz Mechling

ORCID ID

Contact details

Institute of Sport Gerontology
German Sport University Cologne
Am Sportpark Muengersdorf 6
Cologne
50933
Germany
+49 (0)221 4982 6148
mechling@dshs-koeln.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

MoCog - Intervention study on motor and cognitive performance of older adults with and without Alzheimer’s disease [MoKog - Eine Interventionsstudie zur körperlichen und geistigen Leistungsfähigkeit bei älteren Personen mit und ohne Alzheimer Demenz]

Acronym

MoCog [MoKog]

Study hypothesis

The aims of the study are:
1. To analyse the differences in motor and cognitive performance between:
1.1. Healthy and demented persons
1.2. Physically active and inactive persons
2. To show whether increased physical activity reduces the progression of Alzheimer's disease
3. To examine the relationship between physical activity across life span and cognitive performance
4. To examine:
4.1. The correlation of motor and cognitive performance
4.2. The influence of Alzheimer's disease on motor performance
4.3. The effect of the genetic risk factor APOE4 on cognitive performance and health-related fitness
5. To improve motor and cognitive performance through exercise training
6. To compare the effectiveness of different exercise programs (endurance and strength training)
7. To evaluate the feasibility and acceptance of the exercise training program

Ethics approval

Ethics-Committee of the Institute of Pharmacology and Toxicology, Rheinische Friedrich-Wilhelm University of Bonn, gave approval on the 21st November 2003 (ref: 156/03). Amendment on 23rd January 2006 (ref: 179/03).

Study design

Interventional randomised controlled trial nested within a cross-sectional, longitudinal study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Alzheimer's disease

Intervention

1. Intervention group:
Participants exercise two times per week for three months. Every session comprises 60 minutes (5 - 10 minute warm-up and 5 - 10 minute cool-down on an ergometer). Participants were divided into either a strength training group or an endurance training group:

1.1. Strength training group:
Weight training of the major muscle groups for 60 minutes per session. Starting with strength-endurance and intramuscular coordination training (40 - 60% of one repetition maximum [RM], three sets of 20 repetitions) in the initial starting program (first 4 weeks), followed by hypertrophy training (80% of one RM, three sets of 8 - 12 repetitions) for 8 weeks. The intensity of loading was gradually increased, adapted on subjectively perceived exertion (16 to 18 points on the Borg scale).

1.2. Endurance training group:
The endurance training on an ergometer was in accordance with the American College of Sports Medicine's (ACSM's) guidelines for exercise prescription. Volume and intensity of effort were gradually increased every week, starting at 20 minutes and 50 - 60% heart rate (HR) and ending at 60 minutes and 75 - 80% HR max.

2. Control group:
The participants of the control group received no intervention. Possible changes in physical activities in the intervention group and control group were controlled by a questionnaire.

Total duration of treatment: 24 training sessions
Total duration of follow-up: 2 - 5 days

Scientific Contact details:
Dr Sabine Eichberg
Institute of Sport Gerontology
German Sport University Cologne
Am Sportpark Muengersdorf 6
Cologne 50933
Germany
Email: eichberg@dshs-koeln.de

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Health status: genotype testing (Presilin-1-Gen, Presilin-2-Gen, Apolipoprotein E2, 3, 4), measured pre-test only
2. Health-related fitness, measured pre-test and post-test:
2.1. Endurance via ergometer (World Health Organization [WHO] protocol, lactate analysis)
2.2. Maximal isometric strength (knee flexion, knee extension, hip adduction, hip abduction, forearm extension, forearm flexion, hand grip)
2.3. Strength-endurance (chair rising, arm-curl)
2.4. Flexibility (trunk and head rotation, back scratch, sit and reach)
2.5. Reaction and movement time (simple/choice reaction)
2.6. Fine motor movement (hand-eye coordination)
2.7. Balance (Romberg Test with and without visual control, Tandem and Semi-Tandem Stand)
3. Cognitive function, measured pre-test and post-test:
3.1. Cognitive screening (Mini Mental Status Test [MMST])
3.2. Vocabulary (Multiple-Choice Word Test [MWT-B])
3.3. Immediate verbal and visual-spatial memory span (Corsi Block Tapping Test)
3.4. Digits forward/backward (Wechsler Adult Intelligence Scale [WAIS])
3.5. Information processing speed and attention (d2, Trail-Making Test Parts A and B [TMT A/B])
3.6. Perceptual speed and response inhibition (cerebraler Insutfizienz Test [c.I.Test])
3.7. Word fluency and mental rotation (Leistungsprufsystem [LPS])
3.8. Anticipation and planning (Maze Test)
3.9. Verbal learning (Verbaler Lern- und Merkfähigkeitstest [VLMT])

Secondary outcome measures

1. Health status, measured pre-test and post-test:
1.1. Body composition
1.2. Chronic diseases
1.3. Functional limitations
1.4. Pain
1.5. Rate of falls
1.6. Medication
1.7. Geriatric assessment
1.8. Self-related health (5-point-Likert scale)
1.9. Depression rating scale
1.10. Locus of control
2. Activities, measured pre-test and post-test:
2.1. Leisure time and social activities
2.2. Physical activities (manner, duration, frequency, intensity, last 12 months and across life span)
3. Feedback (from Alzheimer patients and caregiver/family member) on exercise program, measured post-test only

Overall trial start date

01/04/2006

Overall trial end date

13/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women, aged 49 to 93 years
2. Participants must be able to understand, read, and speak German
3. The patients sample is diagnosed with Alzheimer's disease (light or moderate) which was assessed with the Consortium to establish a Registry for Alzheimer's Disease (CERAD) neuropsychological test battery
4. Participants must have an mini-mental state examination (MMSE) score greater than or equal to 10 points
5. Participants without Alzheimer's disease have to be older than 60 years and must have an MMSE score greater than or equal to 24

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. Patients with one of the following diseases:
1.1. Acute coronary heart diseases
1.2. Thrombophlebitis
1.3. Acute lung diseases
1.4. Infections
1.5. Osteoporosis
2. Patients who are not able to sit or stand without aid

Recruitment start date

01/04/2006

Recruitment end date

13/08/2007

Locations

Countries of recruitment

Germany

Trial participating centre

Institute of Sport Gerontology
Cologne
50933
Germany

Sponsor information

Organisation

Institute of Sport Science (Germany)

Sponsor details

University of Bonn
Nachtigallenweg 86
Bonn
53127
Germany
mechling@uni-bonn.de

Sponsor type

Research organisation

Website

http://www1.uni-bonn.de/startseite/jsp/index.jsp

Funders

Funder type

University/education

Funder name

University of Bonn (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

German Sport University Cologne (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

Publication citations

Additional files

Editorial Notes