Ignite Creation Date:
2024-05-06 @ 9:37 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03034746
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2017-01-10
Brief Title:
Impact of Physical Activity on Successful Aging
Sponsor:
Universita di Verona
Organization:
Universita di Verona
Study Overview
Official Title:
Impact of Physical Activity on Successful Aging Multidisciplinary Analysis of Mechanisms and Outcomes
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Emerging literature suggests that vascular factors might be involved in the pathogenesis of Alzheimers 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
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 andor interfering with standing position andor 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 Reitan1958
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
Alzheimers 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 slowprevent the decline In particular the treatment will be focused on reorient the patient about hisher-self hisher history and hisher 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-minutesession and 3 daysweek 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
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 andor interfering with standing position andor 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 Reitan1958
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
Alzheimers 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 slowprevent the decline In particular the treatment will be focused on reorient the patient about hisher-self hisher history and hisher 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-minutesession and 3 daysweek 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None