Plain English Summary
Not provided at time of registration
Trial website
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 Alzheimers 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
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