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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ron Postuma, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01573260
First received: April 5, 2012
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Other: Argentinean Tango classes
Other: Simple pamphlet about the exercise in PD
Phase 0

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients will be eligible for inclusion if they have a diagnosis of idiopathic PD.
  • The subjects must speak either English or French sufficiently to fill out questionnaires and understand the instructions for dance classes (classes will be bilingual).

Exclusion Criteria:

  1. Patients who cannot stand for at least 30 min and walk for ≥3 m without an assistive device.
  2. Individuals with Hoehn and Yahr stage IV- V (severe and nonambulatory)
  3. Dementia, defined according to PD dementia criteria as MMSE< 26/30 and ADL impairment secondary to cognitive loss, or inability to understand consent process60
  4. Serious hearing and vision problems that could affect the participation in dance classes.
  5. Change to dopaminergic therapy over the preceding three months, or changes to antiparkinsonian medication are anticipated during the study protocol
  6. Serious medical conditions, including cardiac disease or evidence of musculoskeletal problem which precludes dancing or can be worsened by exercise
  7. History of frequent falls, with more than 3 falls in the last 12 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573260

Contacts
Contact: Ronald Postuma, MD 1-514-934-8058 ron.postuma@mcgill.ca
Contact: Amellie Pelletier, PhD 1-514-934-1934 ext 44705 Amelie.Pelletier@clinepi.mcgill.ca

Locations
Canada, Quebec
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G1A4
Contact: Ronald Postuma, MD    1-514-934-8058    ronpsotuma@mcgill.ca   
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         
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Ronald Postuma, MD Montreal General Hospital
  More Information

No publications provided

Responsible Party: Ron Postuma, Assistant Professor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01573260     History of Changes
Other Study ID Numbers: GEN-11-261
Study First Received: April 5, 2012
Last Updated: April 26, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
Parkinson's Disease
Tango

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 15, 2014