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

Not Applicable

Active, not recruiting

• Conditions: Mild Cognitive Impairment
• Interventions: Behavioral: Adapted Tango Dancing; Behavioral: Control

• Registration Number: NCT04146818
• Lead Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani

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.

Study Timeline

• Study Start: 2019-09-19
• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-31
• Status Verified: 2023-10
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05
• Primary Completion: 2024-06-29
• Study Completion: 2024-06-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adapted Tango Dancing arm	Adapted Tango Dancing	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)
Control arm	Control	Sessions of psycho-education and advice on healthy life-style (once per month for a total of 6 months)

Primary Outcome Measures

Name	Time	Method
change in overall cognition	baseline, 6 months, 12 months and 24 months	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

Name	Time	Method
change in quality of life	baseline, 6 months, 12 months and 24 months	36 Health Survey
change in genetic biomarkers	baseline, 6 months, 12 months and 24 months	assessment of cellular (leukocytes) microRNA of genes involved in the neurodegeneration process
change in trace elements	baseline, 6 months, 12 months and 24 months	Identification of trace elements (Zn, Cu, Fe, Se) by flame atomic absorption spectrometry
change in functional status	baseline, 6 months, 12 months and 24 months	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 psychological well being	baseline, 6 months, 12 months and 24 months	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 social supports	baseline, 6 months, 12 months and 24 months	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	baseline, 6 months, 12 months and 24 months	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 cognitive status	baseline, 6 months, 12 months and 24 months	Italian version of the Mini Mental State Examination (MMSE)
change in level of cognitive impairment	baseline, 6 months, 12 months and 24 months	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	baseline, 6 months, 12 months and 24 months	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 performance	baseline, 6 months, 12 months and 24 months	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).

Trial Locations

Locations (1)

Cinzia Giuli; 🇮🇹 Fermo, Italy