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

NCT ID: NCT04146818

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-19

Study Completion Date

2024-06-29

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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Adapted Tango Dancing arm

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)

Group Type EXPERIMENTAL

Adapted Tango Dancing

Intervention Type BEHAVIORAL

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.

Control arm

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type BEHAVIORAL

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

Interventions

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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) consisting in music therapy, engagement in social activities, cognitive training and psycho-education.

Intervention Type BEHAVIORAL

Control

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Italy

OTHER_GOV

Sponsor Role collaborator

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cinzia Giuli, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS INRCA

Locations

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Cinzia Giuli

Fermo, , Italy

Site Status

Countries

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Italy

Other Identifiers

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GR-2016-02363041

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

INRCA_04_2019

Identifier Type: -

Identifier Source: org_study_id

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