- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05904171
Cognitive, Affective, and Motor Effects of Tangotherapy in Parkinson's Disease (TANGOPD)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lombardy
-
Milan, Lombardy, Italy, 20122
- Istituto Auxologico Italiano IRCCS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Clinical diagnosis of mild-moderate Parkinson's Disease (modified Hoehn&Yahr Scale 1-3)
Exclusion Criteria:
- Having attended Argentine Tango classes in the past year;
- Having attended Physical Therapy rehabilitation in the past month;
- Other neurological diseases (e.g., stroke, traumatic brain injury, brain tumors)
- Dementia
- Any clinical condition not compatible with physical activity
- Deep Brain Stimulation of infusion pumps implants
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tangotherapy
2 hours of group-based Tangotherapy, weekly, for 6 weeks
|
Learning and practicing a series of moves - both individual and with a partner - taken from Argentine Tango, according to the Riabilitango (R) approach. The training is aimed at improving both physical (e.g., balance, change of direction, coordination, endurance) and cognitive (i.e., learning, divided attention, inhibition, planning) domains, in a pleasant, enjoyable, and inclusive environment. This group-based training will take place twice a week (1h each session), for 6 weeks. |
|
Active Comparator: Physical Activity
2 hours of group-based physical activity, weekly, for 6 weeks
|
Walking and stretching in group twice a week (1h each session), for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Parkinson's Disease Cognitive Rating Scale (PD-CRS) - total score
Time Frame: At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up
|
A battery of cognitive tests of memory, selective attention, visuo-spatial skills, and flexibility.
|
At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up
|
|
Change in Hospital Anxiety and Depression Scale (HADS) - total score
Time Frame: At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up
|
A scale assessing depressive and anxiety symptoms.
|
At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up
|
|
Change in Health-related quality of Life (EQ-5D-5L) - total score
Time Frame: At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up
|
A questionnaire about quality of life in different health-related domains.
|
At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up
|
|
Change in Stroop Task - reading time
Time Frame: At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up
|
A test assessing cognitive inhibition.
|
At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up
|
|
Change in 6 minutes walking Test (6MWT) - Distance Walked
Time Frame: At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up
|
A test assessing walking performance; i.e., distance walked in 6 minutes.
|
At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up
|
|
Change in Timed Up and Go (TUG) test - Execution Time
Time Frame: At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up
|
A test used to assess a person's mobility.
|
At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up
|
|
Change in 10 meters walking test (10mWT) - Execution Time
Time Frame: At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up
|
A test assessing walking performance.
|
At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nadia Bolognini, PhD, Laboratorio di Neuropsicologia, IRCCS Istituto Auxologico Italiano
Publications and helpful links
General Publications
- Duncan RP, Earhart GM. Randomized controlled trial of community-based dancing to modify disease progression in Parkinson disease. Neurorehabil Neural Repair. 2012 Feb;26(2):132-43. doi: 10.1177/1545968311421614. Epub 2011 Sep 29.
- Kattenstroth JC, Kolankowska I, Kalisch T, Dinse HR. Superior sensory, motor, and cognitive performance in elderly individuals with multi-year dancing activities. Front Aging Neurosci. 2010 Jul 21;2:31. doi: 10.3389/fnagi.2010.00031. eCollection 2010.
- Kattenstroth JC, Kalisch T, Holt S, Tegenthoff M, Dinse HR. Six months of dance intervention enhances postural, sensorimotor, and cognitive performance in elderly without affecting cardio-respiratory functions. Front Aging Neurosci. 2013 Feb 26;5:5. doi: 10.3389/fnagi.2013.00005. eCollection 2013.
- Carvalho A, Rea IM, Parimon T, Cusack BJ. Physical activity and cognitive function in individuals over 60 years of age: a systematic review. Clin Interv Aging. 2014 Apr 12;9:661-82. doi: 10.2147/CIA.S55520. eCollection 2014.
- Ismail SR, Lee SWH, Merom D, Megat Kamaruddin PSN, Chong MS, Ong T, Lai NM. Evidence of disease severity, cognitive and physical outcomes of dance interventions for persons with Parkinson's Disease: a systematic review and meta-analysis. BMC Geriatr. 2021 Sep 22;21(1):503. doi: 10.1186/s12877-021-02446-w.
- Rios Romenets S, Anang J, Fereshtehnejad SM, Pelletier A, Postuma R. Tango for treatment of motor and non-motor manifestations in Parkinson's disease: a randomized control study. Complement Ther Med. 2015 Apr;23(2):175-84. doi: 10.1016/j.ctim.2015.01.015. Epub 2015 Feb 9.
- Caronni A, Amadei M, Diana L, Sangalli G, Scarano S, Perucca L, Rota V, Bolognini N. In Parkinson's disease, dual-tasking reduces gait smoothness during the straight-walking and turning-while-walking phases of the Timed Up and Go test. BMC Sports Sci Med Rehabil. 2025 Mar 7;17(1):42. doi: 10.1186/s13102-025-01068-8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Parkinson Disease
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
- 25C304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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