DementiaMOTODEMNCT02196545
Physical Activity Training Program for Patients With Alzheimer's Dementia
A study testing Exercise in people with Dementia, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The purpose of this study is to determine if a home based physical activity training program for patients with Alzheimer's dementia has effects on clinical and neurobiological parameters. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >55 years
- German is the dominant language (necessary for neuropsychological testing)
- minimum of 8 years formal school education
- caregiver (e.g. spouse) living at home with participant
- physical examination does not reveal contraindications to physical activity
- stable dose of pharmacological dementia treatment according to German guidelines (DGPPN) with acetylcholinesterase inhibitor or memantin or combination for at least 6 months
- no other medication that could influence cognitive functioning (e.g. benzodiazepines, sleep aids, neuroleptics)
Who cannot join
- history of neurological or psychiatric disease other than AD
- history of substance abuse disorder
- history of electroconvulsive therapy (ECT) during the last 6 months
- structural brain deficits diagnosed in the MRI scan, also without clinical relevance (incidental finding)
- pacemaker, artificial heart valve, insulin pump or other medical implants
- average steps/day are above 10.000 steps/day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Easily Accessible Physical Activity Training Program for Patients With Alzheimer's Dementia: Effect on Clinical and Neurobiological Parameters (MOTODEM)
The purpose of this study is to determine if a home based physical activity training program for patients with Alzheimer's dementia has effects on clinical and neurobiological parameters.
- Conditions
- Dementia
- Being tested
- Exercise
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called (RECK MotoMed®)
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercise, patients train on a specifically programmed movement trainer three times a week for 30 minutes (total duration 12 weeks) Receives: Behavioral: Exercise |
| Treatment as usual | No intervention | Treatment according to guidelines of German Society for Psychiatry, Psychotherapy and Nervous Diseases (DGPPN) and German Society of Neurology (DGN) without movement trainer exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
activities of daily living
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)
Measured: change from baseline after 12 weeks
Secondary outcomes (6)
behavioral symptoms of dementia
Neuropsychiatric Inventory (NPI) total score
Measured: change from baseline after 12 weeks and 24 weeks
cognition
Mini Mental Status Examination (MMSE)
Measured: change from baseline after 12 weeks and 24 weeks
executive function and language ability
semantic and phonemic word fluency
Measured: change from baseline after 12 weeks and 24 weeks
caregiver burden
Neuropsychiatric inventory (NPI) total burden score
Measured: change from baseline after 12 weeks and 24 weeks
Reaction time, hand-eye quickness and attention
Ruler Drop Test
Measured: change from baseline after 12 weeks and 24 weeks
activities of daily living
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)
Measured: change from baseline after 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startAug 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- RECK-Technik GmbH & Co. KG
- Responsible party
- Sponsor
- Investigators
- Vjera A Holthoff, Prof., Principal investigator, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196545
- Sponsor's protocol ID
- MTDEM-001
- Acronym
- MOTODEM
- Status last verified
- Jul 2014
- First submitted
- 14 Jul 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Holthoff VA, Marschner K, Scharf M, Steding J, Meyer S, Koch R, Donix M. Effects of physical activity training in patients with Alzheimer's dementia: results of a pilot RCT study. PLoS One. 2015 Apr 17;10(4):e0121478. doi: 10.1371/journal.pone.0121478. eCollection 2015.
PubMed 25884637
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Easily Accessible Physical Activity Training Program for Patients With Alzheimer's Dementia: Effect on Clinical and Neurobiological Parameters (MOTODEM)
- ClinicalTrials.gov ID
- NCT02196545
- Acronym / sponsor ID
- MOTODEM / MTDEM-001
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- RECK-Technik GmbH & Co. KG
- Study start
- Aug 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if a home based physical activity training program for patients with Alzheimer's dementia has effects on clinical and neurobiological parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseExercise, patients train on a specifically programmed movement trainer three times a week for 30 minutes (total duration 12 weeks) |
| Treatment as usual | No intervention | –Treatment according to guidelines of German Society for Psychiatry, Psychotherapy and Nervous Diseases (DGPPN) and German Society of Neurology (DGN) without movement trainer exercise |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age >55 years
- German is the dominant language (necessary for neuropsychological testing)
- minimum of 8 years formal school education
- caregiver (e.g. spouse) living at home with participant
- physical examination does not reveal contraindications to physical activity
Key exclusion criteria (6 listed)
- history of neurological or psychiatric disease other than AD
- history of substance abuse disorder
- history of electroconvulsive therapy (ECT) during the last 6 months
- structural brain deficits diagnosed in the MRI scan, also without clinical relevance (incidental finding)
- pacemaker, artificial heart valve, insulin pump or other medical implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: (RECK MotoMed®) | Behavioural | Exercise |
Primary outcome
activities of daily living
Time frame: change from baseline after 12 weeks
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)
6 secondary outcomes
behavioral symptoms of dementia
Time frame: change from baseline after 12 weeks and 24 weeks
cognition
Time frame: change from baseline after 12 weeks and 24 weeks
executive function and language ability
Time frame: change from baseline after 12 weeks and 24 weeks
caregiver burden
Time frame: change from baseline after 12 weeks and 24 weeks
Reaction time, hand-eye quickness and attention
Time frame: change from baseline after 12 weeks and 24 weeks
activities of daily living
Time frame: change from baseline after 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
- Derived from this study: PubMed 25884637Holthoff VA, Marschner K, Scharf M, Steding J, Meyer S, Koch R, Donix M. Effects of physical activity training in patients with Alzheimer's dementia: results of a pilot RCT study. PLoS One. 2015 Apr 17;10(4):e0121478. doi: 10.1371/journal.pone.0121478. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vjera A Holthoff, Prof. principal investigator
Technische Universität Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Dementia, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
activities of daily living (time frame: change from baseline after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02196545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2014.