Tango for Treatment of Motor and Non-motor Manifestations in Parkinson's Disease.

NCT01573260 | Completed Early Phase 1 Results DMC

• 1 other identifier: GEN-11-261
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease involves many motor difficulties as well as non-motor ones. Recent research has strongly suggested that exercise is very important for Parkinson's disease. We are interested especially in dance as a form of exercise, because it combines physical movements with balance tasks, social engagement, and mental stimulation. Therefore, we think dance classes may be a very beneficial exercise for Parkinson's disease; the purpose of this study is to see if Argentinean Tango classes might improve motor and non-motor manifestations of Parkinson's disease.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Tango

Outcome Measures

Primary Outcomes (1)

• Severity of PD (Unified Parkinson Disease Rating Scale - UPDRS, 2008 Version)

  This is the standard scale used for grading severity of PD. It starts with a patient self-administered questionnaire covering activities of daily living, motor symptoms, and non-motor domains. It also includes a systematic rated clinical interview assessing cognitive and psychiatric symptoms and motor complications of disease. A Hoehn and Yahr scale (5-point overall disease severity index) is included. Finally, there is a formal examination component (Part III) (performed in the medication 'on' state for this study). Total score for Unified Parkinson Disease Rating Scale is the sum of six subscales, ranging from 0 (best possible outcome) to 60 (worst possible symptoms)

  26 weeks

Secondary Outcomes (13)

• MiniBESTest

  26 weeks

• Number of Participants With a Fall in the Past 3 Months Using the Falls Questionnaire From the Canadian Longitudinal Study of Aging

  26 weeks

• Freezing of Gait Questionnare (FOG_Q)

  26 weeks

• The Purdue Pegboard

  26 weeks

• The Montreal Cognitive Assessment

  26 weeks

Study Arms (2)

Argentinean Tango

EXPERIMENTAL

A biweekly class of argentinean tango for a period of 3-months the intervention for this arm

Other: Argentinean Tango classes

A 'wait-list' control group

PLACEBO COMPARATOR

Intervention: Patient will receive information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.

Other: Simple pamphlet about the exercise in PD

Interventions

Argentinean Tango classes OTHER

Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors.

Argentinean Tango

Simple pamphlet about the exercise in PD OTHER

Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual.

A 'wait-list' control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects must speak either English or French sufficiently to fill out questionnaires and understand the instructions for dance classes (classes will be bilingual).

You may not qualify if:

• Patients who cannot stand for at least 30 min and walk for ≥3 m without an assistive device.
• Individuals with Hoehn and Yahr stage IV- V (severe and nonambulatory)
• Dementia, defined according to PD dementia criteria as MMSE\< 26/30 and ADL impairment secondary to cognitive loss, or inability to understand consent process60
• Serious hearing and vision problems that could affect the participation in dance classes.
• Change to dopaminergic therapy over the preceding three months, or changes to antiparkinsonian medication are anticipated during the study protocol
• Serious medical conditions, including cardiac disease or evidence of musculoskeletal problem which precludes dancing or can be worsened by exercise
• History of frequent falls, with more than 3 falls in the last 12 months

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G1A4, Canada

Location

Related Publications (2)

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Limitations and Caveats

This was a relatively small study, and many of our negative results could be related to inadequate power. The higher baseline activity rate in the controls may have affected responsiveness to change.

Results Point of Contact

• Title: Dr.Ronald B Postuma
• Organization: McGill University

ron.postuma@mcgill.ca

514-934-8026

Study Officials

• Ronald Postuma, MD

  Montreal General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: April 9, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2014
• Last Updated: February 1, 2016
• Results First Posted: February 1, 2016

Record last verified: 2015-12

Locations

CA (1)