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Alzheimer DiseaseNCT03034746

Impact of Physical Activity on Successful Aging

A study testing Physical activity (PA) and cognitive treatment (CT) in people with Alzheimer Disease and Cognitive Impairment, run by Universita di Verona.

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

Emerging literature suggests that vascular factors might be involved in the pathogenesis of Alzheimer's disease (AD). Other recent studies demonstrate the positive effects of physical activity on cognitive and behavioral disturbances of patients with AD. Read more about this study

Who is it for?
Ages 65 to 90 yearsHealthy volunteers can take part
What is being tested?
Physical activity (PA) and cognitive treatment (CT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
Sep 2013to Oct 2016
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 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • age ≥ 65 years;
  • Mini Mental State Examination (MMSE) ≥ 8;
  • Performance Oriented Mobility Assessment ≥ 19 (POMA).

Who cannot join

  • presence of other concurrent neurological diseases;
  • presence of other orthopaedic diseases involving the lower limbs and/or interfering with standing position and/or walking;
  • presence of severe auditory and visual deficits not corrected;
  • abuse of alcohol or drugs;
  • psychiatric disorders,
  • severe behavioral disorders;
  • hearth and respiratory disease that interfere with the motor activity.

About this study

Official title: Impact of Physical Activity on Successful Aging: Multidisciplinary Analysis of Mechanisms and Outcomes

Emerging literature suggests that vascular factors might be involved in the pathogenesis of Alzheimer's disease (AD). Other recent studies demonstrate the positive effects of physical activity on cognitive and behavioral disturbances of patients with AD. Therefore, it has been postulated that exercise enchantment in cerebral circulation is the physiological mechanism that link physical exercise and reduction of AD symptoms. Consequently, a program of physical activity could be considered one approach to counteract dementia by improving cerebrovascular health.

However at this moment, it is not clear if the progressive brain vascular dysfunction and hypoperfusion, associated with the β-amyloid deposition, might be reversed or stabilized by an exercise intervention.

Read more

The aim of this study is to assess, in patients with AD, the influence of physical exercise, compared to cognitive stimulation, on:

  • Cognitive function;
  • Independence in daily living and behavioral symptoms;
  • Vascular function Finally, to investigate the physiological processes on the basis of the motor parameters' changes, the performances of the patients will be compared with the performances of healthy young and old subjects.

MAIN OBJECTIVE: Investigate, in patients with Mild Cognitive Impairment (MCI) and AD, the effects of a physical activity program, or cognitive stimulation on global cognitive function.

SECONDARY OBJECTIVES: Investigate the effects of the two treatments on:

  • cognitive and motor performances,
  • independence in activities of daily living,
  • behavioral symptoms,
  • peripheral vascular function.
Read the detailed description

STUDY DESIGN:

Randomised controlled, blinded clinical trial.

SUBJECTS:

The study will include 120 patients with definite diagnosis of MCI or AD and 30 young healthy subjects and 30 old healthy subjects referred to the Research Unit associated with the Department.

Patients will be regarded as suitable to participate if they fulfilled the following criteria:

  • Mini Mental State Examination (MMSE) ≥ 8;
  • Performance Oriented Mobility Assessment ≥ 19 (POMA).

Exclusion criteria will be:

  • presence of other concurrent neurological diseases;
  • presence of other orthopaedic diseases involving the lower limbs and/or interfering with standing position and/or walking;
  • presence of severe auditory and visual deficits not corrected;
  • abuse of alcohol or drugs;
  • psychiatric disorders,
  • severe behavioral disorders;
  • hearth and respiratory disease that interfere with the motor activity. The protocol was be approved by the local ethics committee with number 2389. All participants will perform a physiatric examination by a medical doctor of the Department of Neurological and Movement Sciences. Written inform consent will be obtained from all participants before inclusion in the study.

Participants who will meet the inclusion criteria will conduct a clinical and instrumental evaluation at enrollment (T0) and after 6 months ± 15 days after the first visit (T1). The assessment procedures will also be repeated after 3 months (T2) from T1.

ASSESSMENT PROCEDURES

Primary endpoints:

  • score obtained in the Mini Mental State Examination.

Secondary endpoints:

  • score obtained in a cognitive battery.

For MCI patients will be used:

  • Trial Making Test (Reitan,1958),
  • Rivermead Behavioral Memory Test (Wilson, 1989),
  • Tower of London (Shallice, 1982),
  • Dual Task (Della Sala et al., 1997),
  • Frontal Assessment Battery (Iavarone A et al., 2004).

For AD patients will be used:

  • Attention Matrix (Spinnler et al., 1987),
  • Alzheimer's Disease Assessment Scale (Rosen WG et al., 1984),
  • Frontal Assessment Battery (Iavarone A et al., 2004).
  • score obtained in a motor skills assessment composed by:
  • 6-Minute Walking Test (Ries JD et al., 2009),
  • gait analysis by GAITRite® System (Bilney B et al., 2003),
  • stabilometric assessments with Stability Line (Nashner LM and Peters JF, 1990),
  • score obtained in the test Instrumental Activity in Daily Living (Lawton MP and Brody EM, 1969),
  • score obtained in the test Neuropsychiatric Inventory (Cummings JL et al., 1994),
  • peripheral vascular function measured by doppler.

To evaluate the effectiveness of motor treatment, compared to a cognitive treatment on motor skills, cognitive skills, behavioral and autonomy in patients with cognitive decline, all patients will be evaluated by motor, cognitive, behavioral and autonomy scales, at baseline, after 6 months (T1), and after others 3 months (T2). A subgroup of 50% of patients will undergo instrumental procedures to investigate the effects of treatments on cerebral blood flow (arterial spin labeling).

TREATMENT PROCEDURES

The participants will be recruited and randomly assigned, according to the degree of cognitive decline, to one of the 3 groups (7-8 subjects):

  • Physical Activity group (PA group): It will perform a program consist of 15 min of warm-up, 60 min of aerobic and resistance training, and 15 min of cool-down.
  • Cognitive treatment group (CT group): The cognitive stimulation group will received a rehabilitation program with multimodal repetitive stimulation in order to exercise and reinforce the cognitive skills of the participant to slow/prevent the decline. In particular the treatment will be focused on reorient the patient about his/her-self, his/her history and his/her environment, to improve the memory skill by teaching compensatory and restitutive strategies, to help the patient to the discussion about everyday life and in particular to the everyday problems The PA and CT groups will be homogeneous for clinical and demographic data, and participants will undergo 72 treatment group sessions, 60-minute/session, and 3 days/week for 6 consecutively months.

Both types of treatment will be balanced with different degrees of difficulty depending on the state of disease severity .

  • The control groups (CG) will not receive any such treatment during the study and they will be evaluated by the same clinical and instrumental assessments.
Being tested
Physical activity (PA), cognitive treatment (CT)
Keywords
alzheimer's disease, physical activity, cognitive training
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction, Motor Activity

What participants receive

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

  • Physical activity (PA)Other

    It will perform a program consist of 15 min of warm-up, 60 min of aerobic and resistance training, and 15 min of cool-down.

  • cognitive treatment (CT)Other

    The cognitive stimulation group will received a rehabilitation program with multimodal repetitive stimulation in order to exercise and reinforce the cognitive skills of the participant to slow/prevent the decline. In particular the treatment will be focused on reorient the patient about his/her-self, his/her history and his/her environment, to improve the memory skill by teaching compensatory and restitutive strategies, to help the patient to the discussion about everyday life and in particular to the everyday problems

Study groups in NCT03034746
Study groupRoleWhat they receive
Alzheimer's Disease (G1)Experimental(G1) physical activity (PA)
Receives: Other: Physical activity (PA)
Alzheimer's Disease (G2)Experimental(G2) cognitive treatment (CT)
Receives: Other: cognitive treatment (CT)
Healthy Old Subjects (G1)No interventionControl group old
Healthy young Subjects (G2)No interventionControl group young

What is being measured

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

  1. Mini Mental State Examination

    Measured: 0-6-9 months (change will be assessed)

Secondary outcomes (14)

  1. Trail Making Test

    For MCI patients (Reitan,1958)

    Measured: 0-6-9 months (change will be assessed)

  2. Rivermead Behavioral Memory Test

    For MCI patients (Wilson, 1989)

    Measured: 0-6-9 months (change will be assessed)

  3. Tower of London

    For MCI patients (Shallice, 1982)

    Measured: 0-6-9 months (change will be assessed)

  4. Dual Task

    For MCI patients (Della Sala et al., 1997)

    Measured: 0-6-9 months (change will be assessed)

  5. Frontal Assessment Battery

    (Iavarone A et al., 2004)

    Measured: 0-6-9 months (change will be assessed)

  6. Attention Matrix

    For AD patients (Spinnler et al., 1987)

    Measured: 0-6-9 months (change will be assessed)

  7. Alzheimer's Disease Assessment Scale

    For AD patients (Rosen WG et al., 1984)

    Measured: 0-6-9 months (change will be assessed)

  8. 6-Minute Walking Test

    (Ries JD et al., 2009)

    Measured: 0-6-9 months (change will be assessed)

  9. gait analysis by GAITRite® System

    (Bilney B et al., 2003)

    Measured: 0-6-9 months (change will be assessed)

  10. stabilometric assessments with Stability Line

    (Nashner LM and Peters JF, 1990),

    Measured: 0-6-9 months (change will be assessed)

  11. Instrumental Activity in Daily Living Scale (IADL)

    Measured: 0-6-9 months (change will be assessed)

  12. Neuropsychiatric Inventory Scale (NPI)

    Measured: 0-6-9 months (change will be assessed)

  13. cerebral circulation

    measured MRI arterial spin labeling

    Measured: 0-6-9 months (change will be assessed)

  14. peripheral vascular function

    measured by vascular doppler

    Measured: 0-6-9 months (change will be assessed)

Timeline

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

  1. First posted27 Jan 2017 (estimated)
  2. Study startSep 2013
  3. Primary completionMay 2016
  4. Study completionOct 2016

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03034746
Sponsor's protocol ID
PRIN_2010
Status last verified
Jan 2017
First submitted
10 Jan 2017
Last updated
30 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Venturelli M, Lanza M, Muti E, Schena F. Positive effects of physical training in activity of daily living-dependent older adults. Exp Aging Res. 2010 Apr;36(2):190-205. doi: 10.1080/03610731003613771.

    PubMed 20209421

  • Venturelli M, Scarsini R, Schena F. Six-month walking program changes cognitive and ADL performance in patients with Alzheimer. Am J Alzheimers Dis Other Demen. 2011 Aug;26(5):381-8. doi: 10.1177/1533317511418956. Epub 2011 Aug 17.

    PubMed 21852281

  • Venturelli M, Magalini A, Scarsini R, Schena F. From Alzheimer's disease retrogenesis: a new care strategy for patients with advanced dementia. Am J Alzheimers Dis Other Demen. 2012 Nov;27(7):483-9. doi: 10.1177/1533317512459794. Epub 2012 Sep 13.

    PubMed 22984089

  • Venturelli M, Scarsini R, Muti E, Salvagno GL, Schena F. Sundowning syndrome and hypothalamic-pituitary-adrenal axis dysregulation in individuals with Alzheimer's disease: is there an association? J Am Geriatr Soc. 2013 Nov;61(11):2055-6. doi: 10.1111/jgs.12491. No abstract available.

    PubMed 24219216

  • Venturelli M, Ce E, Limonta E, Muti E, Scarsini R, Brasioli A, Schena F, Esposito F. Possible Predictors of Involuntary Weight Loss in Patients with Alzheimer's Disease. PLoS One. 2016 Jun 27;11(6):e0157384. doi: 10.1371/journal.pone.0157384. eCollection 2016.

    PubMed 27347878

  • Venturelli M, Sollima A, Ce E, Limonta E, Bisconti AV, Brasioli A, Muti E, Esposito F. Effectiveness of Exercise- and Cognitive-Based Treatments on Salivary Cortisol Levels and Sundowning Syndrome Symptoms in Patients with Alzheimer's Disease. J Alzheimers Dis. 2016 Jul 14;53(4):1631-40. doi: 10.3233/JAD-160392.

    PubMed 27540967

  • Crispoltoni L, Stabile AM, Pistilli A, Venturelli M, Cerulli G, Fonte C, Smania N, Schena F, Rende M. Changes in Plasma beta-NGF and Its Receptors Expression on Peripheral Blood Monocytes During Alzheimer's Disease Progression. J Alzheimers Dis. 2017;55(3):1005-1017. doi: 10.3233/JAD-160625.

    PubMed 27802234

  • Pedrinolla A, Venturelli M, Tamburin S, Fonte C, Stabile AM, Galazzo IB, Ghinassi B, Venneri MA, Pizzini FB, Muti E, Smania N, Di Baldassarre A, Naro F, Rende M, Schena F. Non-Abeta-Dependent Factors Associated with Global Cognitive and Physical Function in Alzheimer's Disease: A Pilot Multivariate Analysis. J Clin Med. 2019 Feb 9;8(2):224. doi: 10.3390/jcm8020224.

    PubMed 30744116

  • Pedrinolla A, Venturelli M, Fonte C, Munari D, Benetti MV, Rudi D, Tamburin S, Muti E, Zanolla L, Smania N, Schena F. Exercise Training on Locomotion in Patients with Alzheimer's Disease: A Feasibility Study. J Alzheimers Dis. 2018;61(4):1599-1609. doi: 10.3233/JAD-170625.

    PubMed 29376858

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity (PA) and cognitive treatment (CT) in people with Alzheimer Disease and Cognitive Impairment, run by Universita di Verona.

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 3 inclusion and 7 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 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Mini Mental State Examination (time frame: 0-6-9 months (change will be assessed)). 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 NCT03034746, which also lists 9 linked publications.

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 30 Jan 2017.

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