NCT03034746

Brief 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. 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable alzheimer-disease

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

2.7 years

First QC Date

January 10, 2017

Last Update Submit

January 27, 2017

Conditions

Alzheimer DiseaseCognitive ImpairmentPhysical Activity

Keywords

alzheimer's disease, physical activity, cognitive training

Outcome Measures

Primary Outcomes (1)

  • Mini Mental State Examination

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

Secondary Outcomes (14)

  • Trail Making Test

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

  • Rivermead Behavioral Memory Test

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

  • Tower of London

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

  • Dual Task

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

  • Frontal Assessment Battery

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

  • +9 more secondary outcomes

Study Arms (4)

Alzheimer's Disease (G1)

EXPERIMENTAL

(G1) physical activity (PA)

Other: Physical activity (PA)

Alzheimer's Disease (G2)

EXPERIMENTAL

(G2) cognitive treatment (CT)

Other: cognitive treatment (CT)

Healthy Old Subjects (G1)

NO INTERVENTION

Control group old

Healthy young Subjects (G2)

NO INTERVENTION

Control group young

Interventions

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.

Alzheimer's Disease (G1)
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

Alzheimer's Disease (G2)

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 20209421RESULT

  • 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.

    PMID: 21852281RESULT

  • 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.

    PMID: 22984089RESULT

  • 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.

    PMID: 24219216RESULT

  • 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.

    PMID: 27347878RESULT

  • 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.

    PMID: 27540967RESULT

  • 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.

    PMID: 27802234RESULT

  • 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.

    PMID: 30744116DERIVED

  • 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.

    PMID: 29376858DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nicola Smania

    Department of Neurological and Movement Sciences

    STUDY CHAIR

  • Federico Schena

    Department of Neurological and Movement Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Full Professor

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 27, 2017

Study Start

September 1, 2013

Primary Completion

May 1, 2016

Study Completion

October 1, 2016

Last Updated

January 30, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share