Clinical trial NCT04146818: Study of the Effects of Adapted Tango and Multidimensional Intervention in pREvention of Dementia in agiNG (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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
adapted Tango dancing
elderly people
music therapy
psycho-education
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2019-10-31
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: change in overall cognition
timeFrame: baseline, 6 months, 12 months and 24 months
Secondary outcomes:
measure: change in cognitive status
timeFrame: baseline, 6 months, 12 months and 24 months
measure: change in level of cognitive impairment
timeFrame: baseline, 6 months, 12 months and 24 months
measure: change in depressive symptoms
timeFrame: baseline, 6 months, 12 months and 24 months
measure: change in functional status
timeFrame: baseline, 6 months, 12 months and 24 months
measure: change in functional performance
timeFrame: baseline, 6 months, 12 months and 24 months
measure: change in social supports
timeFrame: baseline, 6 months, 12 months and 24 months
measure: change in the physical performance
timeFrame: baseline, 6 months, 12 months and 24 months
measure: change in psychological well being
timeFrame: baseline, 6 months, 12 months and 24 months
measure: change in quality of life
timeFrame: baseline, 6 months, 12 months and 24 months
measure: change in genetic biomarkers
timeFrame: baseline, 6 months, 12 months and 24 months
measure: change in trace elements
timeFrame: baseline, 6 months, 12 months and 24 months
Other outcomes:
Locations:
city: Fermo
country: Italy
facility: Cinzia Giuli
Study officials:
affiliation: IRCCS INRCA
name: Cinzia Giuli, PhD
role: PRINCIPAL_INVESTIGATOR
References: