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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01573260
Recruitment Status : Completed
First Posted : April 9, 2012
Results First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Information provided by (Responsible Party):
Ron Postuma, McGill University Health Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Parkinson's Disease
Interventions: Other: Argentinean Tango classes
Other: Simple pamphlet about the exercise in PD

  Participant Flow

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
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 

  Baseline Characteristics

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
Control No text entered.
Tango No text entered.
Total Total of all reporting groups

Baseline Measures
   Control   Tango   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   18   33 
[Units: Years]
Mean (Standard Deviation)
 64.3  (8.1)   63.2  (9.9)   63.7  (9.08) 
[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

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

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

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

Responsible Party: Ron Postuma, McGill University Health Center Identifier: NCT01573260     History of Changes
Other Study ID Numbers: GEN-11-261
First Submitted: April 5, 2012
First Posted: April 9, 2012
Results First Submitted: April 15, 2015
Results First Posted: February 1, 2016
Last Update Posted: February 1, 2016