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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Active, not recruiting

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Control; Behavioral: Adapted Tango Dancing

Study type: Interventional

Funder types: Other

Identifiers

NCT04146818

GR-2016-02363041 (Other Grant/Funding Number)

INRCA_04_2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups, including a placebo group

Adapted Tango Dancing arm

Experimental group

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)

Treatment:

Behavioral: Adapted Tango Dancing

Control arm

Placebo Comparator group

Description:

Sessions of psycho-education and advice on healthy life-style (once per month for a total of 6 months)

Treatment:

Behavioral: Control