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Cognitive, Affective, and Motor Effects of Tangotherapy in Parkinson's Disease (TANGOPD)

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Tangotherapy
Physical activity
Sponsored by
Istituto Auxologico Italiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease, Argentine Tango, Dance Therapy, Cognition

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Auxologico Italiano IRCCSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tangotherapy

Physical Activity

Arm Description

2 hours of group-based Tangotherapy, weekly, for 6 weeks

2 hours of group-based physical activity, weekly, for 6 weeks

Outcomes

Primary Outcome Measures

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.
Change in Hospital Anxiety and Depression Scale (HADS) - total score
A scale assessing depressive and anxiety symptoms.
Change in Health-related quality of Life (EQ-5D-5L) - total score
A questionnaire about quality of life in different health-related domains.
Change in Stroop Task - reading time
A test assessing cognitive inhibition.
Change in 6 minutes walking Test (6MWT) - Distance Walked
A test assessing walking performance; i.e., distance walked in 6 minutes.
Change in Timed Up and Go (TUG) test - Execution Time
A test used to assess a person's mobility.
Change in 10 meters walking test (10mWT) - Execution Time
A test assessing walking performance.

Secondary Outcome Measures

Full Information

First Posted
May 25, 2023
Last Updated
June 6, 2023
Sponsor
Istituto Auxologico Italiano
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1. Study Identification

Unique Protocol Identification Number
NCT05904171
Brief Title
Cognitive, Affective, and Motor Effects of Tangotherapy in Parkinson's Disease
Acronym
TANGOPD
Official Title
Cognitive, Affective, and Motor Effects of Tangotherapy in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Auxologico Italiano

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's Disease, Argentine Tango, Dance Therapy, Cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tangotherapy
Arm Type
Experimental
Arm Description
2 hours of group-based Tangotherapy, weekly, for 6 weeks
Arm Title
Physical Activity
Arm Type
Active Comparator
Arm Description
2 hours of group-based physical activity, weekly, for 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Tangotherapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Intervention Description
Walking and stretching in group twice a week (1h each session), for 6 weeks.
Primary Outcome Measure Information:
Title
Change in Parkinson's Disease Cognitive Rating Scale (PD-CRS) - total score
Description
A battery of cognitive tests of memory, selective attention, visuo-spatial skills, and flexibility.
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
Title
Change in Hospital Anxiety and Depression Scale (HADS) - total score
Description
A scale assessing depressive and anxiety symptoms.
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
Title
Change in Health-related quality of Life (EQ-5D-5L) - total score
Description
A questionnaire about quality of life in different health-related domains.
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
Title
Change in Stroop Task - reading time
Description
A test assessing cognitive inhibition.
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
Title
Change in 6 minutes walking Test (6MWT) - Distance Walked
Description
A test assessing walking performance; i.e., distance walked in 6 minutes.
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
Title
Change in Timed Up and Go (TUG) test - Execution Time
Description
A test used to assess a person's mobility.
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
Title
Change in 10 meters walking test (10mWT) - Execution Time
Description
A test assessing walking performance.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadia Bolognini, PhD
Phone
+390261911
Ext
6127
Email
n.bolognini@auxologico.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadia Bolognini, PhD
Organizational Affiliation
Laboratorio di Neuropsicologia, IRCCS Istituto Auxologico Italiano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Auxologico Italiano IRCCS
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadia Bolognini, PhD
Phone
+39025821
Ext
8132
Email
n.bolognini@auxologico.it

12. IPD Sharing Statement

Citations:
PubMed Identifier
24748784
Citation
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.
Results Reference
background
PubMed Identifier
23447455
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.
Results Reference
background
PubMed Identifier
20725636
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.
Results Reference
background
PubMed Identifier
34551722
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.
Results Reference
background
PubMed Identifier
21959675
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.
Results Reference
background
PubMed Identifier
25847555
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.
Results Reference
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Cognitive, Affective, and Motor Effects of Tangotherapy in Parkinson's Disease

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