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Mild Cognitive ImpairmentSTRENGTHNCT04146818

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

A study testing Adapted Tango Dancing in people with Mild Cognitive Impairment, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Adapted Tango Dancing
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
1 siteItaly
Study dates
19 Sep 2019to 29 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosis of mild cognitive impairment
  • presence of a caregiver
  • capability to sign the informed consent

Who cannot join

  • diagnosis of dementia
  • serious medical and/or psychiatric conditions

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Cinzia Giuli

    Fermo, 63900

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Adapted Tango Dancing, Control
Keywords
Mild Cognitive Impairment, adapted Tango dancing, elderly people, music therapy, psycho-education
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adapted Tango DancingBehavioural

    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.

  • ControlBehavioural

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

Study groups in NCT04146818
Study groupRoleWhat they receive
Adapted Tango Dancing armExperimentalTreatment 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)
Receives: Behavioral: Adapted Tango Dancing
Control armPlacebo comparatorSessions of psycho-education and advice on healthy life-style (once per month for a total of 6 months)
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in overall cognition

    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.

    Measured: baseline, 6 months, 12 months and 24 months

Secondary outcomes (11)

  1. change in cognitive status

    Italian version of the Mini Mental State Examination (MMSE)

    Measured: baseline, 6 months, 12 months and 24 months

  2. change in level of cognitive impairment

    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.

    Measured: baseline, 6 months, 12 months and 24 months

  3. change in depressive symptoms

    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.

    Measured: baseline, 6 months, 12 months and 24 months

  4. change in functional status

    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).

    Measured: baseline, 6 months, 12 months and 24 months

  5. change in functional performance

    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).

    Measured: baseline, 6 months, 12 months and 24 months

  6. change in social supports

    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.

    Measured: baseline, 6 months, 12 months and 24 months

  7. change in the physical performance

    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.

    Measured: baseline, 6 months, 12 months and 24 months

  8. change in psychological well being

    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).

    Measured: baseline, 6 months, 12 months and 24 months

  9. change in quality of life

    36 Health Survey

    Measured: baseline, 6 months, 12 months and 24 months

  10. change in genetic biomarkers

    assessment of cellular (leukocytes) microRNA of genes involved in the neurodegeneration process

    Measured: baseline, 6 months, 12 months and 24 months

  11. change in trace elements

    Identification of trace elements (Zn, Cu, Fe, Se) by flame atomic absorption spectrometry

    Measured: baseline, 6 months, 12 months and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2019
  2. Study start19 Sep 2019
  3. Primary completion29 Jun 2024 (estimated)
  4. Study completion29 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04146818
Sponsor's protocol ID
INRCA_04_2019
Other IDs
GR-2016-02363041
Acronym
STRENGTH
Status last verified
Oct 2023
First submitted
25 Oct 2019
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Adapted Tango Dancing in people with Mild Cognitive Impairment, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in overall cognition (time frame: baseline, 6 months, 12 months and 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04146818.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.

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