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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05904171
Other study ID # 25C304
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 20, 2023
Est. completion date December 2024

Study information

Verified date March 2024
Source Istituto Auxologico Italiano
Contact Nadia Bolognini, PhD
Phone +390261911
Email n.bolognini@auxologico.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Neuroscientific research has shown a close relationship between physical fitness and cognition, showing a positive effect of physical activity (e.g., aerobic activity) on the maintenance of psycho-cognitive well-being in the elderly. In particular, dancing seems to be very effective, as it involves both motor and multisensory aspects (touch, sight, hearing, proprioception), stimulating memory, motor learning and social interaction. In fact, dance increases sensory-motor skills and cognitive performance in the neurologically healthy elderly. Dance-based therapeutic approaches, in particular Argentine tango, have also been implemented in the context of neurodegenerative pathologies, including Parkinson's disease (PD) where motor (i.e., tremors, postural instability, motor slowdown) and cognitive difficulties (e.g., executive deficits) may coexist. Most of these studies have so far demonstrated a significant improvement in balance and a reduction in motor symptoms, while evidence regarding cognitive and emotional benefits brought about by dance remains limited. When investigated, cognitive benefits have often been evaluated at the level of global cognition (i.e., screening tests), without a detailed characterization of the effects of tango on cognitive and affective functioning (e.g., executive functions, social cognition, depressive symptoms), central aspects in Parkinson's disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Tangotherapy
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.
Physical activity
Walking and stretching in group twice a week (1h each session), for 6 weeks.

Locations

Country Name City State
Italy Istituto Auxologico Italiano IRCCS Milan Lombardia

Sponsors (1)

Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Parkinson's Disease Cognitive Rating Scale (PD-CRS) - total score 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
Primary Change in Hospital Anxiety and Depression Scale (HADS) - total score 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
Primary Change in Health-related quality of Life (EQ-5D-5L) - total score 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
Primary Change in Stroop Task - reading time 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
Primary Change in 6 minutes walking Test (6MWT) - Distance Walked 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
Primary Change in Timed Up and Go (TUG) test - Execution Time 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
Primary Change in 10 meters walking test (10mWT) - Execution Time 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
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