Study of the Effects of Adapted Tango and Multidimensional Intervention in pREvention of Dementia in agiNG (STRENGTH)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of the Effects of Adapted Tango and Multidimensional Intervention in pREvention of Dementia in agiNG: Developing healTHy Life Style Programs. (STRENGTH)

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Adapted Tango Dancing
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adapted Tango Dancing arm<br>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) | Behavioral: Adapted Tango Dancing<br>* 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.<br>|
| Placebo Comparator: Control arm<br>Sessions of psycho-education and advice on healthy life-style (once per month for a total of 6 months) | Behavioral: Control<br>* Sessions of psycho-education and advice on healthy life-style (once per month for a total of 6 months)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, 6 months, 12 months and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in cognitive status | Italian version of the Mini Mental State Examination (MMSE) | baseline, 6 months, 12 months and 24 months | 
| 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. | baseline, 6 months, 12 months and 24 months | 
| 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. | baseline, 6 months, 12 months and 24 months | 
| 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). | baseline, 6 months, 12 months and 24 months | 
| 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). | baseline, 6 months, 12 months and 24 months | 
| 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. | baseline, 6 months, 12 months and 24 months | 
| 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. | baseline, 6 months, 12 months and 24 months | 
| 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). | baseline, 6 months, 12 months and 24 months | 
| change in quality of life | 36 Health Survey | baseline, 6 months, 12 months and 24 months | 
| change in genetic biomarkers | assessment of cellular (leukocytes) microRNA of genes involved in the neurodegeneration process | baseline, 6 months, 12 months and 24 months | 
| change in trace elements | Identification of trace elements (Zn, Cu, Fe, Se) by flame atomic absorption spectrometry | baseline, 6 months, 12 months and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild Cognitive Impairment, adapted Tango dancing, elderly people, music therapy, psycho-education