Tango for Treatment of Motor and Non-motor Manifestations in Parkinson's Disease.
Recruitment status was Recruiting
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.
Other: Argentinean Tango classes
Other: Simple pamphlet about the exercise in PD
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Tango for Treatment of Motor and Non-motor Manifestations in Parkinson's Disease: A Randomized Control Study.|
- Severity of PD (Unified Parkinson Disease Rating Scale - UPDRS, 2008 version) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]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).
- Other motor complications [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Total 'off' time (in hours) and the presence of dyskinesia will be recorded, on clinical interview.
- MiniBESTest [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Balance will be assessed using a 14-item tool measuring performance of dynamic balance tasks. This test has high interrater and test-retest reliability in PD (intraclass correlation coefficient ≥ .92 and intraclass correlation coefficient ≥.88 respectively). Lower scores indicate greater deficits in balance.
- The falls questionnaire from the Canadian Longitudinal Study of Aging [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Falls will be assessed using the falls questionnaire from the Canadian Longitudinal Study of Aging focusing on the past 3 months.
- Freezing of Gait Questionnare (FOG_Q) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Freezing of gait will be assessed using the Freezing of Gait Questionnare (FOG_Q), a 6-item tool measuring walking and freezing episodes. Higher scores indicate greater difficulty with walking and freezing.
- The Purdue Pegboard [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]The Purdue Pegboard, a test of dexterity and speed in the hands will be assessed over 1 minute.
- The Montreal Cognitive Assessment [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]This tool was designed to screen for mild cognitive impairment. This includes visuospatial tests (clock drawing, trail making, cube copying), confrontation naming, attention (digit span, backwards digit span, "A" test, sentence repetition), tests of verbal fluency, abstraction, short term memory, and orientation. Recently, it has been used widely in PD, and demonstrates excellent sensitivity for subtle cognitive deficits. Alternate versions (7.1 to 7.3, with a randomly-distributed order) will be administered to prevent training effects.
- The Beck Depression Inventory (BDI) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]The BDI is a self-administered scale of 21 items (scored 0-3) which assesses depression symptoms. The Beck Inventory is one of the most commonly-used scales for depression in PD, and a recent consensus panel of the Movement Disorders Society concluded it was a scale of first choice for assessing depression in PD.
- Apathy Evaluation Scale (AES) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]This is a 14-item patient-rated scale which measures cognitive, emotional, and behavioural symptoms of apathy. All items are rated on a 0 to 3 Likert Scale. The original 18-item scale has been shortened by four items, and wording simplified and it was reported to have excellent psychometric properties in PD (internal consistency reliability = 0.76, test-retest 1 week r = 0.90).
- The Krupp Fatigue Severity Scale [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]The fatigue severity scale measures impact of fatigue with a 9-item questionnaire, with a 7-point Likert scale for each question It has been validated, and has been used in PD studies.
- The Parkinson's Disease Questionnaire is a quality of life(PDQ-39) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]The PDQ-39 is a quality of life index for PD. It consists of a 39-item questionnaire that asks about the impact of PD on a person's motor function, gait, mood, cognition, and activities of daily living.
- Adherence to treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Compliance with dance therapy will be conducted by reconfirming the regular assistance to the dance sessions at week 12, to compare how many sessions were attended by the participants. The dance instructors will keep the track of dance classes' assistance.
- Clinical global impression of change [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]Completed by both the examiner and the patient, the scale is a single question" Since you have enrolled in the study, how has your Parkinson's disease changed?". It will be scored as very much improved (6), much improved (5), minimally improved (4), no change (3), minimally worse (2), much worse (1), or very much worse(0).
- Exit questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]An exit questionnaire will be completed by participants to assess program experience, asking them to rank level of enjoyment items and overall satisfaction on a scale of 1 to 5. An open-ended question will allow them to note particular challenges or suggestions for improvement.
- Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Adverse events will be queried week 12 through a semi structured interview querying increase in falls, fatigue, pain, cramps or pain, in addition to open-ended questions regarding other potential adverse events. Events will be rated by the patient and investigator as mild, moderate, or serious. All serious adverse events will be reported to the research ethics board
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: Argentinean Tango
A biweekly 3-month tango program
Other: Argentinean Tango classes
Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors.
Placebo Comparator: 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.
Other: 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.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573260
|Contact: Ronald Postuma, MDfirstname.lastname@example.org|
|Contact: Amellie Pelletier, PhD||1-514-934-1934 ext 44705||Amelie.Pelletier@clinepi.mcgill.ca|
|Montreal General Hospital||Recruiting|
|Montreal, Quebec, Canada, H3G1A4|
|Contact: Ronald Postuma, MD 1-514-934-8058 email@example.com|
|Contact: Amellie Pelletier, PhD 1-514-934-1934 ext 44705 Amelie.Pelletier@clinepi.mcgill.ca|
|Principal Investigator: Ronald Postuma, MD|
|Sub-Investigator: Silvia Rios Romenets, MD|
|Sub-Investigator: Amelie Pelletier, PhD|
|Principal Investigator:||Ronald Postuma, MD||Montreal General Hospital|