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DementiaSMARTNCT02343029

Physical Activity and Cerebral Metabolism in the Elderly: a Randomised Controlled Trial

A study testing Individualised aerobic exercise training in people with Dementia and Cognitive Impairment, run by Professor Johannes Pantel at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Physical activity exerts a variety of long-term health benefits in older adults.This randomised controlled trial investigates the effect of a 12-week physical exercise program on the change in cerebral metabolism as assessed with Magnetic Resonance Spectroscopic Imaging. Follow-up lasts for 6 months. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Dementia, Cognitive Impairment
What is being tested?
Individualised aerobic exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesGermany
Study dates
Jun 2014to Aug 2015
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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • be above 65 years of age,
  • voluntariness
  • capacity to consent,
  • having passed medical entry exam by the Department of Sports Medicine,
  • 4) regular mental capacity, 5) written informed consent

Who cannot join

  • untreated clotting disorders,
  • musculoskeletal diseases significantly reducing mobility,
  • severe bacterial or viral infections,
  • severe respiratory diseases (Gold IV),
  • acute pulmonary embolism,
  • instable angina pectoris or severe heart failure (NYHA III or IV),
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  • severe vascular disease of the extremities or the brain,
  • severe pulmonary-cardiac dysfunction,
  • acute myocardial infarction or early phase of rehabilitation,
  • critical aortal stenosis,
  • severe hypertrophic and obstructive cardiomyopathy,
  • untreated malignant arrhythmias,
  • untreated severe hypertonia,
  • severe pulmonary hypertonia,
  • symptomatic cardiac malformations,
  • cardiac-block grade II or III,
  • left bundle branch block,
  • complex ventricular arrhythmias,
  • Cognitive impairment

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Department of Sports Medicine, Institute of Sports Sciences, Goethe University

    Frankfurt am Main, 60487

  • Institute of General Practice, Goethe University,

    Frankfurt am Main, 60590

Other trials in Germany

About this study

Physical activity exerts a variety of long-term health benefits in older adults.This randomised controlled trial investigates the effect of a 12-week physical exercise program on the change in cerebral metabolism as assessed with Magnetic Resonance Spectroscopic Imaging. Follow-up lasts for 6 months.

Being tested
Individualised aerobic exercise training, Waiting Control
Keywords
Aerobic Exercise Training, prevention, magnetic resonance spectroscopic imaging, psychometric tests, cognition, dementia, cognitive impairment
Medical subject headings
Dementia, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individualised aerobic exercise trainingOther

    During the first 4 weeks of intervention two of the three weekly training sessions are offered as group training supervised by the respective qualified exercise physiologist of the Department of Sports Medicine. After 4 weeks, participants' physical performance is reassessed at the Department of Sports Medicine. If necessary, workload is readjusted to achieve the initially defined exercise intensity.

  • Waiting ControlOther

    After waiting for 12 weeks with normal daily activity, patients are allocated to a individualised aerobic exercise training, too.

Study groups in NCT02343029
Study groupRoleWhat they receive
InterventionExperimentalParticipants in the Intervention group exercise three times a week for 30 minutes on a bicycle ergometer (optibike med, ergoline GmbH, Bitz, Germany) in the integrated gym hall of one of the participating residencies. Training is individualised as respective performance is adapted to the power at the first ventilator threshold (assessed during cardiopulmonary exercise test).
Receives: Other: Individualised aerobic exercise training
Waiting ControlActive comparatorParticipants of Waiting Control continue their regular physical activity behaviour for 12 weeks. They will start the same exercise intervention after a reassessment at week 12 for the next upcoming 12 weeks. (13-24)
Receives: Other: Individualised aerobic exercise training; Other: Waiting Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cerebral metabolism (assessed by MRSI)

    assessed by MRSI, Primary hypothesis is that aerobic exercise leads to an increase of cerebral N-acetyl-aspartate (NAA; mediated by plasma neurotrophins).

    Secondary hypothesis stipulates an increase of markers of neuronal energy reserve: i.e. the ratio of phosphocreatinin to creatinine and of adenosine-tri-phosphate (ATP) to ~di-phosphate (ADP).

    Third hypothesis is an increase in the volume of cortical grey matter

    Measured: 6 month

Secondary outcomes (15)

  1. Cardiopulmonary exercise test (Aerobic exercise capacity is determined by a physician-supervised CPET)

    Aerobic exercise capacity is determined by a physician-supervised CPET

    Measured: 0, 3 and 6 month

  2. Psychometric testing 1 (verbal declarative memory [Verbal Learning and Memory test; adapted German version of the Rey Auditory Verbal Learning test]

    verbal declarative memory [Verbal Learning and Memory test; adapted German version of the Rey Auditory Verbal Learning test]

    Measured: 0, 3 and 6 month

  3. Psychometric testing 2 (frontal executive control [Colour-Word-Interference test; adapted German version of the Stroop test; Trail-Making-Test Part B]

    frontal executive control [Colour-Word-Interference test; adapted German version of the Stroop test; Trail-Making-Test Part B]

    Measured: 0, 3 and 6 month

  4. Psychometric testing 3 (working memory [Digit Span Test forward and backward]

    working memory [Digit Span Test forward and backward]

    Measured: 0, 3 and 6 month

  5. Psychometric testing 4 9semantic and phonematic fluency, nonverbal declarative memory and visual-constructive abilities by means of the CERAD-Plus (Consortium to Establish a Registry for Alzheimer's Disease) Neuropsychological Battery)

    semantic and phonematic fluency, nonverbal declarative memory and visual-constructive abilities by means of the CERAD-Plus (Consortium to Establish a Registry for Alzheimer's Disease) Neuropsychological Battery

    Measured: 0, 3 and 6 month

  6. Psychometric testing 5 (speed of cognitive processing is assessed by means of the Trail-Making-Test Part A)

    speed of cognitive processing is assessed by means of the Trail-Making-Test Part A

    Measured: 0, 3 and 6 month

  7. Psychometric testing 6 (depressive disorders: Geriatric Depression Scale)

    depressive disorders: Geriatric Depression Scale

    Measured: 0, 3 and 6 month

  8. Psychometric testing 7 (Age-associated subjective memory impairment is assessed using a memory complaint questionnaire [MAC-Q]

    Age-associated subjective memory impairment is assessed using a memory complaint questionnaire [MAC-Q]

    Measured: 0, 3 and 6 month

  9. Psychometric testing 8 (cristalline intelligence is assessed by means of a verbal intelligence test [Multiple-Choice Word Test: MWT-B]

    cristalline intelligence is assessed by means of a verbal intelligence test [Multiple-Choice Word Test: MWT-B]

    Measured: 0, 3 and 6 month

  10. Psychometric testing 9 (dementia and mild cognitive impairment using the Mini Mental State Examination and the Instrumental Activities of Daily Living Questionnaire)

    dementia and mild cognitive impairment using the Mini Mental State Examination and the Instrumental Activities of Daily Living Questionnaire

    Measured: 0, 3 and 6 month

  11. Balance and strength (postural sway (balance) and gait data acquisition via the capacitive force-measuring platform (30 Hz) WinFDM v0.0.41® (Zebris© GmbH, Isny, Germany)

    postural sway (balance) and gait data acquisition via the capacitive force-measuring platform (30 Hz) WinFDM v0.0.41® (Zebris© GmbH, Isny, Germany)

    Measured: 0, 3 and 6 month

  12. Pain Assessment (German Pain Questionnaire)

    German Pain Questionnaire

    Measured: 0, 3 and 6 month

  13. History of diet (Food frequency questionnaire DEGS1)

    Food frequency questionnaire DEGS1

    Measured: 0, 3 and 6 month

  14. History and fear of falling (German version of the Falls-Efficacy-Scale International Version)

    German version of the Falls-Efficacy-Scale International Version

    Measured: 0, 3 and 6 month

  15. Physical activity (International Physical Activity Questionnaire, Lifetime Total Physical Activity Questionnaire and Accelerometry)

    International Physical Activity Questionnaire, Lifetime Total Physical Activity Questionnaire and Accelerometry

    Measured: 0, 3 and 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2015 (estimated)
  2. Study startJun 2014
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02343029
Sponsor's protocol ID
SMART
Acronym
SMART
Status last verified
Aug 2015
First submitted
12 Jan 2015
Last updated
2 Sep 2015
Results posted
No
Data monitoring committee
No

Publications

  • Fleckenstein J, Matura S, Engeroff T, Fuzeki E, Tesky VA, Pilatus U, Hattingen E, Deichmann R, Vogt L, Banzer W, Pantel J. SMART: physical activity and cerebral metabolism in older people: study protocol for a randomised controlled trial. Trials. 2015 Apr 11;16:155. doi: 10.1186/s13063-015-0662-9.

    PubMed 25872789

Questions about this trial

What is this clinical trial studying?

A study testing Individualised aerobic exercise training in people with Dementia and Cognitive Impairment, run by Professor Johannes Pantel at 2 sites 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 5 inclusion and 19 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 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Change in cerebral metabolism (assessed by MRSI) (time frame: 6 month). 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 NCT02343029, 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 2 Sep 2015.

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