NCT04146818

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 25, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2024

Completed
Last Updated

March 5, 2024

Status Verified

October 1, 2023

Enrollment Period

4.8 years

First QC Date

October 25, 2019

Last Update Submit

March 4, 2024

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairmentadapted Tango dancingelderly peoplemusic therapypsycho-education

Outcome Measures

Primary Outcomes (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.

    baseline, 6 months, 12 months and 24 months

Secondary Outcomes (11)

  • change in cognitive status

    baseline, 6 months, 12 months and 24 months

  • change in level of cognitive impairment

    baseline, 6 months, 12 months and 24 months

  • change in depressive symptoms

    baseline, 6 months, 12 months and 24 months

  • change in functional status

    baseline, 6 months, 12 months and 24 months

  • change in functional performance

    baseline, 6 months, 12 months and 24 months

  • +6 more secondary outcomes

Study Arms (2)

Adapted Tango Dancing arm

EXPERIMENTAL

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

Control arm

PLACEBO COMPARATOR

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

Behavioral: Control

Interventions

Adapted Tango DancingBEHAVIORAL

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.

Adapted Tango Dancing arm
ControlBEHAVIORAL

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

Control arm

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cinzia Giuli

Fermo, 63900, Italy

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Cinzia Giuli, PhD

    IRCCS INRCA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2019

First Posted

October 31, 2019

Study Start

September 19, 2019

Primary Completion

June 29, 2024

Study Completion

June 29, 2024

Last Updated

March 5, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)