Impact of Physical Activity on Successful Aging
Primary Purpose
Alzheimer Disease, Cognitive Impairment, Physical Activity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical activity (PA)
cognitive treatment (CT)
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring alzheimer's disease, physical activity, cognitive training
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
No Intervention
No Intervention
Arm Label
Alzheimer's Disease (G1)
Alzheimer's Disease (G2)
Healthy Old Subjects (G1)
Healthy young Subjects (G2)
Arm Description
(G1) physical activity (PA)
(G2) cognitive treatment (CT)
Control group old
Control group young
Outcomes
Primary Outcome Measures
Mini Mental State Examination
Secondary Outcome Measures
Trail Making Test
For MCI patients (Reitan,1958)
Rivermead Behavioral Memory Test
For MCI patients (Wilson, 1989)
Tower of London
For MCI patients (Shallice, 1982)
Dual Task
For MCI patients (Della Sala et al., 1997)
Frontal Assessment Battery
(Iavarone A et al., 2004)
Attention Matrix
For AD patients (Spinnler et al., 1987)
Alzheimer's Disease Assessment Scale
For AD patients (Rosen WG et al., 1984)
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),
Instrumental Activity in Daily Living Scale (IADL)
Neuropsychiatric Inventory Scale (NPI)
cerebral circulation
measured MRI arterial spin labeling
peripheral vascular function
measured by vascular doppler
Full Information
NCT ID
NCT03034746
First Posted
January 10, 2017
Last Updated
January 27, 2017
Sponsor
Universita di Verona
1. Study Identification
Unique Protocol Identification Number
NCT03034746
Brief Title
Impact of Physical Activity on Successful Aging
Official Title
Impact of Physical Activity on Successful Aging: Multidisciplinary Analysis of Mechanisms and Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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 .
o 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Cognitive Impairment, Physical Activity
Keywords
alzheimer's disease, physical activity, cognitive training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alzheimer's Disease (G1)
Arm Type
Experimental
Arm Description
(G1) physical activity (PA)
Arm Title
Alzheimer's Disease (G2)
Arm Type
Experimental
Arm Description
(G2) cognitive treatment (CT)
Arm Title
Healthy Old Subjects (G1)
Arm Type
No Intervention
Arm Description
Control group old
Arm Title
Healthy young Subjects (G2)
Arm Type
No Intervention
Arm Description
Control group young
Intervention Type
Other
Intervention Name(s)
Physical activity (PA)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
cognitive treatment (CT)
Intervention Description
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
Primary Outcome Measure Information:
Title
Mini Mental State Examination
Time Frame
0-6-9 months (change will be assessed)
Secondary Outcome Measure Information:
Title
Trail Making Test
Description
For MCI patients (Reitan,1958)
Time Frame
0-6-9 months (change will be assessed)
Title
Rivermead Behavioral Memory Test
Description
For MCI patients (Wilson, 1989)
Time Frame
0-6-9 months (change will be assessed)
Title
Tower of London
Description
For MCI patients (Shallice, 1982)
Time Frame
0-6-9 months (change will be assessed)
Title
Dual Task
Description
For MCI patients (Della Sala et al., 1997)
Time Frame
0-6-9 months (change will be assessed)
Title
Frontal Assessment Battery
Description
(Iavarone A et al., 2004)
Time Frame
0-6-9 months (change will be assessed)
Title
Attention Matrix
Description
For AD patients (Spinnler et al., 1987)
Time Frame
0-6-9 months (change will be assessed)
Title
Alzheimer's Disease Assessment Scale
Description
For AD patients (Rosen WG et al., 1984)
Time Frame
0-6-9 months (change will be assessed)
Title
6-Minute Walking Test
Description
(Ries JD et al., 2009)
Time Frame
0-6-9 months (change will be assessed)
Title
gait analysis by GAITRite® System
Description
(Bilney B et al., 2003)
Time Frame
0-6-9 months (change will be assessed)
Title
stabilometric assessments with Stability Line
Description
(Nashner LM and Peters JF, 1990),
Time Frame
0-6-9 months (change will be assessed)
Title
Instrumental Activity in Daily Living Scale (IADL)
Time Frame
0-6-9 months (change will be assessed)
Title
Neuropsychiatric Inventory Scale (NPI)
Time Frame
0-6-9 months (change will be assessed)
Title
cerebral circulation
Description
measured MRI arterial spin labeling
Time Frame
0-6-9 months (change will be assessed)
Title
peripheral vascular function
Description
measured by vascular doppler
Time Frame
0-6-9 months (change will be assessed)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Smania
Organizational Affiliation
Department of Neurological and Movement Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Federico Schena
Organizational Affiliation
Department of Neurological and Movement Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20209421
Citation
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.
Results Reference
result
PubMed Identifier
21852281
Citation
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.
Results Reference
result
PubMed Identifier
22984089
Citation
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.
Results Reference
result
PubMed Identifier
24219216
Citation
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.
Results Reference
result
PubMed Identifier
27347878
Citation
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.
Results Reference
result
PubMed Identifier
27540967
Citation
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.
Results Reference
result
PubMed Identifier
27802234
Citation
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.
Results Reference
result
PubMed Identifier
30744116
Citation
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.
Results Reference
derived
PubMed Identifier
29376858
Citation
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.
Results Reference
derived
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Impact of Physical Activity on Successful Aging
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