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.

  Hide Detailed Description

Detailed Description:

There is accumulating evidence for positive effects of exercise on gait speed, strength, balance, and quality of life for people with PD. Habitual physical activity can lower risk for developing PD. In toxin-induced animal models of PD, exercise may decrease neuronal injury. The key components of an exercise program in PD include: 1) cueing strategies to improve gait; 2) cognitive movement strategies to improve transfers; 3) exercises to improve balance, and 4) training of joint mobility and muscle power to physical capacity. Traditional exercise programs can meet these needs but often they are not very appealing for older adults including patients with PD. Unfortunately more than half of individuals with PD does not meet the recommended daily level physical activity.

There is a connection between music and level of Dopamine, which is pivotal for establishing and maintaining behavior. According to recent study music-induced emotional states can increase dopamine release, partially explaining how musical experiences are so valued and why music is an especially potent pleasurable stimulus for most people, and is frequently used to affect emotional states.

The development of interventions which combine exercise, with accessibility, enjoyability, good motivation to practice regularly improving mood and stimulating cognition would be ideal for individuals with PD. Dance may provide all of these characteristics, and so may be an affective useful and accessible intervention to improve motor impairments. Dance requires dynamic balance and permanent adjustment to the environment at the same time. It promotes enjoyment and encouragement interest in continuing participation. Habitual social dancers have superior balance, gait function, and reaction times compared with age-matched nondancers. Regular dancing improves balance and functional mobility, and increases motivation to continue healthful exercise-related behaviours in older adults.

There is also evidence that exercise has a positive impact on cognitive function in vulnerable populations. Musical exercise improved cognitive function in residents of long- term care facilitations without diagnosis of dementia and in patients with established Alzheimer's disease. Particularly dance produces clinically important changes in measures of mental status and behaviour in patients with moderate to severe dementia.

Social isolation is an important cause of the development of depression in the older population and it may be caused by numbers of factors, including mobility limitations: medical illness, and economic difficulties. The relationship between social isolation and depression is clear, as is the link between social engagement and improved mood and perceived quality of life. There is also an important link between social disengagement, depression and cognitive decline in elderly population. Dance classes occur in a group setting and it is forced social interaction, which may produce noticeable improvement in mood and subsequently decrease cognitive decline.

There is currently an insufficient body of literature on dance for PD and much additional work is needed. Most studies on dance in PD have used small sample sizes and assessed short-term effects and long-term effects of dance intervention only focused in motor manifestations of PD. Consequently, the effect of dance on cognition, mood and motivation has not been yet explored in PD. There is insufficient literature about what type of dance is more beneficial for motor and non-motor manifestations in PD.

Why Argentinean tango?

Better improvements of balance and complex gait were observed in elderly participants in tango lessons compared with a walking group. Beneficial effect of Argentine tango was also suggested, compared to traditional exercise for improving balance and functional mobility in patients with PD. Furthermore, a positron emission tomography (PET) study has shown increased activity in the basal ganglia when tango movements were performed with a metered and predictable beat. Tango requires particular motor skills, including frequent initiation and cessation, a variety of movement speeds, rhythmic variation, and spontaneous multidirectional perturbations. These features target motor impairments with movement initiation, turning, and bradykinesia. Interesting, tango could also effectively address freezing of gait (FOG), because some step patterns mimic the rehabilitation exercises designed for those with FOG. Visual cues, such as a foot to step over, can improve FOG. Tango technique which involve stepping over a partner's foot, tapping a partner's foot, or crossing one foot over another, are steps similar to conventional rehabilitation for FOG. In addition, tango involves rhythmic rocking, or alternating shift of center of mass from foot to foot, which can be another good strategy for freezing. Tango appeared to have a larger effect on freezing compared to other styles of dancing (waltz/foxtrot). Tango involves the practicing of control of movement speed and size, which may improve walking velocity and stride length. It also adds slow and quick steps of varying lengths and requires continual adjustment of these features. Tango may be especially beneficial for addressing backward walking, a critical area given the tendency for falls in the backward direction in PD6. Surprisingly in a recent study, tango even significantly improved upper extremity function, which it may be reflective of a global impact of exercise on bradykinesia. Better improvements of balance and complex gait were observed in elderly participants in tango lessons compared with a walking group. No studies have examined the effect of tango on cognitive function, mood and motivation in patients with PD.

  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

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 September 18, 2014