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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ron Postuma, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01573260
First received: April 5, 2012
Last updated: December 21, 2015
Last verified: December 2015
Results First Received: April 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Parkinson's Disease
Interventions: Other: Argentinean Tango classes
Other: Simple pamphlet about the exercise in PD

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Argentinean Tango

A biweekly 3-month tango program

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

A 'Wait-list' Control Group

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

Simple pamphlet about the exercise in PD: 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.


Participant Flow:   Overall Study
    Argentinean Tango     A 'Wait-list' Control Group  
STARTED     18     15  
COMPLETED     18     15  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control No text entered.
Tango No text entered.
Total Total of all reporting groups

Baseline Measures
    Control     Tango     Total  
Number of Participants  
[units: participants]
  15     18     33  
Age  
[units: years]
Mean (Standard Deviation)
  64.3  (8.1)     63.2  (9.9)     63.7  (9.08)  
Gender  
[units: participants]
     
Female     8     6     14  
Male     7     12     19  
Disease duration  
[units: years]
Mean (Standard Deviation)
  7.7  (4.6)     5.5  (4.4)     6.5  (4.49)  



  Outcome Measures
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1.  Primary:   Severity of PD (Unified Parkinson Disease Rating Scale - UPDRS, 2008 Version)   [ Time Frame: 26 weeks ]

2.  Secondary:   MiniBESTest   [ Time Frame: 26 weeks ]

3.  Secondary:   Number of Participants With a Fall in the Past 3 Months Using the Falls Questionnaire From the Canadian Longitudinal Study of Aging   [ Time Frame: 26 weeks ]

4.  Secondary:   Freezing of Gait Questionnare (FOG_Q)   [ Time Frame: 26 weeks ]

5.  Secondary:   The Purdue Pegboard   [ Time Frame: 26 weeks ]

6.  Secondary:   The Montreal Cognitive Assessment   [ Time Frame: 26 weeks ]

7.  Secondary:   The Beck Depression Inventory (BDI)   [ Time Frame: 26 weeks ]

8.  Secondary:   Apathy Evaluation Scale (AES)   [ Time Frame: 26 weeks ]

9.  Secondary:   The Krupp Fatigue Severity Scale   [ Time Frame: 26 weeks ]

10.  Secondary:   The Parkinson's Disease Questionnaire is a Quality of Life(PDQ-39)   [ Time Frame: 26 weeks ]

11.  Secondary:   Adherence to Treatment   [ Time Frame: 12 weeks ]

12.  Secondary:   Clinical Global Impression of Change   [ Time Frame: 26 weeks ]

13.  Secondary:   Exit Questionnaire   [ Time Frame: 12 weeks ]

14.  Secondary:   Adverse Events   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr.Ronald B Postuma
Organization: McGill University
phone: 514-934-8026
e-mail: ron.postuma@mcgill.ca



Responsible Party: Ron Postuma, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01573260     History of Changes
Other Study ID Numbers: GEN-11-261
Study First Received: April 5, 2012
Results First Received: April 15, 2015
Last Updated: December 21, 2015
Health Authority: Canada: Ethics Review Committee