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

March 4, 2024 updated by: Istituto Nazionale di Ricovero e Cura per Anziani

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Fermo, Italy, 63900
        • Cinzia Giuli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in overall cognition
Time Frame: 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.
baseline, 6 months, 12 months and 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Collaborators

Ministry of Health, Italy

Investigators

  • Principal Investigator: Cinzia Giuli, PhD, IRCCS INRCA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2019

Primary Completion (Estimated)

June 29, 2024

Study Completion (Estimated)

June 29, 2024

Study Registration Dates

First Submitted

October 25, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 31, 2019

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INRCA_04_2019
  • GR-2016-02363041 (Other Grant/Funding Number: Italian Ministry of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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