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
  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). 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)


Secondary Outcome Measures:
  • 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). Total score for MiniBESTest is the sum of foursubscales, ranging from 0 (worst possible balance) to 28 (best possible balance). Lower scores indicate greater deficits in balance. Two items have right and left assessment in which the lower score is used within the total score (directions specify which to use). For research, we used of both left and right data, thus calculating data based on 32 (vs 28) points.

  • 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 ] [ Designated as safety issue: No ]
    Falls will be assessed using an adapted version of the falls questionnaire from the Canadian Longitudinal Study of Aging focusing on the past 3 months. This questionnaire includes 2 questions to assess if the participants felt during the past year and then it assess if this fall happened within the last 3 months. If a participant answered 'yes' to both questions, then the participant screened positive for this outcome. In the results section, we reported the number of participant who answered 'Yes' to both questions.

  • 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. Six items each scored from 0 to 6 were summed to obtain the total score, ranging from 0 (best possible outcome) to 36 (worst possible outcome).

  • 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. We calculate the number of pins correctly placed on the board in a 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. Total score for the MoCA is the sum of eight subscales, ranging from 0 (worst possible outcome) to 30 (best possible symptoms)"

  • 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. Total score for the BDI is the sum of 21 items, ranging from 0 (best possible outcome) to 63 (worst possible symptoms)"

  • 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). Total score is ranging from 0 (best possible outcome) to 42 (worst possible symptoms).

  • 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. Total score is ranging from 0 (best possible outcome) to 63 (worst possible fatigue).

  • 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. Patients are asked to indicate the frequency of each event by selecting one of 5 options: never/occasionally/sometimes/often/always or cannot do at all. Total score is ranging from 0 (best possible outcome) to 156 (worst possible quality of life).

  • 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 ranking level of enjoyment and overall satisfaction with their dance/exercise program, scored from 1 (strongly agree) to 5 (strongly disagree), with open questions about willingness continuing practicing tango.

  • 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


Enrollment: 33
Study Start Date: April 2012
Study Completion Date: April 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Argentinean Tango
A biweekly class of argentinean tango for a period of 3-months the intervention for this arm
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
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573260

Locations
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G1A4
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Ronald Postuma, MD Montreal General Hospital
  More Information

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
Results First Received: April 15, 2015
Last Updated: December 21, 2015
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on May 24, 2016