Study of the Effects of Adapted Tango and Multidimensional Intervention in pREvention of Dementia in agiNG (STRENGTH) (STRENGTH)
Primary Purpose
Mild Cognitive Impairment
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Adapted Tango Dancing
Control
Sponsored by
About this trial
This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, adapted Tango dancing, elderly people, music therapy, psycho-education
Eligibility Criteria
Inclusion Criteria:
- diagnosis of mild cognitive impairment
- presence of a caregiver
- capability to sign the informed consent
Exclusion Criteria:
- diagnosis of dementia
- serious medical and/or psychiatric conditions
Sites / Locations
- Cinzia GiuliRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Adapted Tango Dancing arm
Control arm
Arm Description
Treatment will include sessions of Adapted Tango (90 min per week for a total of 6 months) together with sessions of comprehensive cognitive intervention (90 min per week for a total of 6 months)
Sessions of psycho-education and advice on healthy life-style (once per month for a total of 6 months)
Outcomes
Primary Outcome Measures
change in overall cognition
Italian version of the Corsi test. This is a neuropsychological instrument, for the assessment of the spatial learning and memory processes. It consists of 9 blocks randomly arranged on a board. The investigator points to a series of blocks at a rate of one block per second, and then the subjects have to point at the same blocks in the same order. The longest sequence correctly reproduced represents the measure of spatial span. An increase of at least 1 point will indicate the success of the intervention.
Secondary Outcome Measures
change in cognitive status
Italian version of the Mini Mental State Examination (MMSE)
change in level of cognitive impairment
Clinical Dementia Rating Scale (CDR). An overall Global CDR® Score may be calculated through the use of an CDR® Scoring Algorithm. This score is useful for characterizing and tracking a patient's level of impairment/dementia: 0 = Normal; 0.5 = Very Mild Dementia; 1 = Mild Dementia; 2 = Moderate Dementia; 3 = Severe Dementia.
change in depressive symptoms
Geriatric depression scale (GDS-15 items). The score ranges from 0 to 15 and a score of zero to four is considered to be within the normal range, five to nine indicates mild depression, and a score of 10 or more indicates moderate to severe depression.
change in functional status
Basic Activities of daily living (BADL). There are 6 domains of function measured with the BADL scale. A summary score ranges from 0 (low function, dependent) to 6 (high function, independent).
change in functional performance
Instrumental Activities of Daily Living (IADL). There are 8 domains of function measured with the Lawton IADL scale. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent).
change in social supports
Lubben Social Network Scale (LSNS). From the sum of the scores of the 11 items derive four categories: 0-19 poor social support (social isolation); 20-25 discreet support; 26-39 good support; > 40 excellent support.
change in the physical performance
6 Minute Walk Test (6MWT). The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
change in psychological well being
Psychological well being scales (PWB). PWB is a 84 item self-rating inventory, which consists of six scales which represent the six dimensions of psychological well-being: self-acceptance, autonomy, environmental mastery, personal growth, purpose in life and positive relations.Respondents rate how strongly they agree or disagree with the statements using a 6-point scale (1 = strongly agree; 6 = strongly disagree).
change in quality of life
36 Health Survey
change in genetic biomarkers
assessment of cellular (leukocytes) microRNA of genes involved in the neurodegeneration process
change in trace elements
Identification of trace elements (Zn, Cu, Fe, Se) by flame atomic absorption spectrometry
Full Information
NCT ID
NCT04146818
First Posted
October 25, 2019
Last Updated
October 20, 2023
Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
Collaborators
Ministry of Health, Italy
1. Study Identification
Unique Protocol Identification Number
NCT04146818
Brief Title
Study of the Effects of Adapted Tango and Multidimensional Intervention in pREvention of Dementia in agiNG (STRENGTH)
Acronym
STRENGTH
Official Title
Study of the Effects of Adapted Tango and Multidimensional Intervention in pREvention of Dementia in agiNG: Developing healTHy Life Style Programs. (STRENGTH)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
Collaborators
Ministry of Health, Italy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The STRENGTH project is a randomized controlled trial to assess the effects of a 6 months multimodal intervention consisted of adapted Tango dancing together with music therapy, engagement in social activities, cognitive intervention and psycho-education on functional, biological, cognitive outcomes and psycho-social aspects in 300 subjects with mild cognitive impairment.
Detailed Description
Cognitive decline represents a pathological condition for elderly with negative consequences on social functioning and independent living. To reduce the incidence of cognitive deficits in mild cognitive impairment (MCI), treatments that prevent or delay dementia are needed. The main objective of STRENGTH Project, is the assessment of the effects of a comprehensive intervention in 300 subjects with MCI, finalized to improve functional, biochemical, cognitive outcomes and psycho-social aspects. The study uses a multidisciplinary approach, has a 3-year duration, and includes 3 follow-up phases. Participants will be assigned to: a) Experimental group, which will undergo a multimodal intervention for improving cognitive outcomes, functional status and mobility. Treatment will include sessions of Adapted tango, music therapy, engagement in social activities, comprehensive cognitive intervention and psycho-education for 6 months; or b) Control group, which will receive psycho-education and advice on healthy life-style for 6 months. Cognitive and psycho-social outcomes, functional, cardiovascular status, life-style characteristics, biochemical determination, will be evaluated at baseline and longitudinally. Our hypothesis is based on expectation that the proposed could improve cognitive, functional outcomes and quality of life, with a positive impact on prevention of onset of dementia and cognitive decline in MCI subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, adapted Tango dancing, elderly people, music therapy, psycho-education
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adapted Tango Dancing arm
Arm Type
Experimental
Arm Description
Treatment will include sessions of Adapted Tango (90 min per week for a total of 6 months) together with sessions of comprehensive cognitive intervention (90 min per week for a total of 6 months)
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
Sessions of psycho-education and advice on healthy life-style (once per month for a total of 6 months)
Intervention Type
Behavioral
Intervention Name(s)
Adapted Tango Dancing
Intervention Description
Treatment will include sessions of Adapted Tango (90 min per week for a total of 6 months) together with sessions of comprehensive cognitive intervention (90 min per week for a total of 6 months) consisting in music therapy, engagement in social activities, cognitive training and psycho-education.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Sessions of psycho-education and advice on healthy life-style (once per month for a total of 6 months)
Primary Outcome Measure Information:
Title
change in overall cognition
Description
Italian version of the Corsi test. This is a neuropsychological instrument, for the assessment of the spatial learning and memory processes. It consists of 9 blocks randomly arranged on a board. The investigator points to a series of blocks at a rate of one block per second, and then the subjects have to point at the same blocks in the same order. The longest sequence correctly reproduced represents the measure of spatial span. An increase of at least 1 point will indicate the success of the intervention.
Time Frame
baseline, 6 months, 12 months and 24 months
Secondary Outcome Measure Information:
Title
change in cognitive status
Description
Italian version of the Mini Mental State Examination (MMSE)
Time Frame
baseline, 6 months, 12 months and 24 months
Title
change in level of cognitive impairment
Description
Clinical Dementia Rating Scale (CDR). An overall Global CDR® Score may be calculated through the use of an CDR® Scoring Algorithm. This score is useful for characterizing and tracking a patient's level of impairment/dementia: 0 = Normal; 0.5 = Very Mild Dementia; 1 = Mild Dementia; 2 = Moderate Dementia; 3 = Severe Dementia.
Time Frame
baseline, 6 months, 12 months and 24 months
Title
change in depressive symptoms
Description
Geriatric depression scale (GDS-15 items). The score ranges from 0 to 15 and a score of zero to four is considered to be within the normal range, five to nine indicates mild depression, and a score of 10 or more indicates moderate to severe depression.
Time Frame
baseline, 6 months, 12 months and 24 months
Title
change in functional status
Description
Basic Activities of daily living (BADL). There are 6 domains of function measured with the BADL scale. A summary score ranges from 0 (low function, dependent) to 6 (high function, independent).
Time Frame
baseline, 6 months, 12 months and 24 months
Title
change in functional performance
Description
Instrumental Activities of Daily Living (IADL). There are 8 domains of function measured with the Lawton IADL scale. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent).
Time Frame
baseline, 6 months, 12 months and 24 months
Title
change in social supports
Description
Lubben Social Network Scale (LSNS). From the sum of the scores of the 11 items derive four categories: 0-19 poor social support (social isolation); 20-25 discreet support; 26-39 good support; > 40 excellent support.
Time Frame
baseline, 6 months, 12 months and 24 months
Title
change in the physical performance
Description
6 Minute Walk Test (6MWT). The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Time Frame
baseline, 6 months, 12 months and 24 months
Title
change in psychological well being
Description
Psychological well being scales (PWB). PWB is a 84 item self-rating inventory, which consists of six scales which represent the six dimensions of psychological well-being: self-acceptance, autonomy, environmental mastery, personal growth, purpose in life and positive relations.Respondents rate how strongly they agree or disagree with the statements using a 6-point scale (1 = strongly agree; 6 = strongly disagree).
Time Frame
baseline, 6 months, 12 months and 24 months
Title
change in quality of life
Description
36 Health Survey
Time Frame
baseline, 6 months, 12 months and 24 months
Title
change in genetic biomarkers
Description
assessment of cellular (leukocytes) microRNA of genes involved in the neurodegeneration process
Time Frame
baseline, 6 months, 12 months and 24 months
Title
change in trace elements
Description
Identification of trace elements (Zn, Cu, Fe, Se) by flame atomic absorption spectrometry
Time Frame
baseline, 6 months, 12 months and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of mild cognitive impairment
presence of a caregiver
capability to sign the informed consent
Exclusion Criteria:
diagnosis of dementia
serious medical and/or psychiatric conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Demetrio Postacchini, MD
Phone
00390718005369
Email
d.postacchini@inrca.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cinzia Giuli, PhD
Organizational Affiliation
IRCCS INRCA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cinzia Giuli
City
Fermo
ZIP/Postal Code
63900
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cinzia Giuli, PhD
Phone
00398005367
Email
c.giuli@inrca.it
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of the Effects of Adapted Tango and Multidimensional Intervention in pREvention of Dementia in agiNG (STRENGTH)
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