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Impact of Physical Activity on Successful Aging

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ClinicalTrials.gov Identifier: NCT03034746
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
prof. Federico Schena, Universita di Verona

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Cognitive Impairment Physical Activity Other: Physical activity (PA) Other: cognitive treatment (CT) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Physical Activity on Successful Aging: Multidisciplinary Analysis of Mechanisms and Outcomes
Study Start Date : September 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : October 2016


Arm Intervention/treatment
Experimental: Alzheimer's Disease (G1)
(G1) physical activity (PA)
Other: Physical activity (PA)
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.

Experimental: Alzheimer's Disease (G2)
(G2) cognitive treatment (CT)
Other: cognitive treatment (CT)
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

No Intervention: Healthy Old Subjects (G1)
Control group old
No Intervention: Healthy young Subjects (G2)
Control group young



Primary Outcome Measures :
  1. Mini Mental State Examination [ Time Frame: 0-6-9 months (change will be assessed) ]

Secondary Outcome Measures :
  1. Trail Making Test [ Time Frame: 0-6-9 months (change will be assessed) ]
    For MCI patients (Reitan,1958)

  2. Rivermead Behavioral Memory Test [ Time Frame: 0-6-9 months (change will be assessed) ]
    For MCI patients (Wilson, 1989)

  3. Tower of London [ Time Frame: 0-6-9 months (change will be assessed) ]
    For MCI patients (Shallice, 1982)

  4. Dual Task [ Time Frame: 0-6-9 months (change will be assessed) ]
    For MCI patients (Della Sala et al., 1997)

  5. Frontal Assessment Battery [ Time Frame: 0-6-9 months (change will be assessed) ]
    (Iavarone A et al., 2004)

  6. Attention Matrix [ Time Frame: 0-6-9 months (change will be assessed) ]
    For AD patients (Spinnler et al., 1987)

  7. Alzheimer's Disease Assessment Scale [ Time Frame: 0-6-9 months (change will be assessed) ]
    For AD patients (Rosen WG et al., 1984)

  8. 6-Minute Walking Test [ Time Frame: 0-6-9 months (change will be assessed) ]
    (Ries JD et al., 2009)

  9. gait analysis by GAITRite® System [ Time Frame: 0-6-9 months (change will be assessed) ]
    (Bilney B et al., 2003)

  10. stabilometric assessments with Stability Line [ Time Frame: 0-6-9 months (change will be assessed) ]
    (Nashner LM and Peters JF, 1990),

  11. Instrumental Activity in Daily Living Scale (IADL) [ Time Frame: 0-6-9 months (change will be assessed) ]
  12. Neuropsychiatric Inventory Scale (NPI) [ Time Frame: 0-6-9 months (change will be assessed) ]
  13. cerebral circulation [ Time Frame: 0-6-9 months (change will be assessed) ]
    measured MRI arterial spin labeling

  14. peripheral vascular function [ Time Frame: 0-6-9 months (change will be assessed) ]
    measured by vascular doppler



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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034746


Sponsors and Collaborators
Universita di Verona
Investigators
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Study Chair: Nicola Smania Department of Neurological and Movement Sciences
Principal Investigator: Federico Schena Department of Neurological and Movement Sciences

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: prof. Federico Schena, MD Full Professor, Universita di Verona
ClinicalTrials.gov Identifier: NCT03034746     History of Changes
Other Study ID Numbers: PRIN_2010
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by prof. Federico Schena, Universita di Verona:
alzheimer's disease, physical activity, cognitive training

Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders