Clinical trial NCT01573260: Tango for Treatment of Motor and Non-motor Manifestations in Parkinson's Disease.
Official title: Tango for Treatment of Motor and Non-motor Manifestations in Parkinson's Disease: A Randomized Control Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Tango
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2012-04-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Severity of PD (Unified Parkinson Disease Rating Scale - UPDRS, 2008 Version)
timeFrame: 26 weeks
Secondary outcomes:
measure: MiniBESTest
timeFrame: 26 weeks
measure: Number of Participants With a Fall in the Past 3 Months Using the Falls Questionnaire From the Canadian Longitudinal Study of Aging
timeFrame: 26 weeks
measure: Freezing of Gait Questionnare (FOG_Q)
timeFrame: 26 weeks
measure: The Purdue Pegboard
timeFrame: 26 weeks
measure: The Montreal Cognitive Assessment
timeFrame: 26 weeks
measure: The Beck Depression Inventory (BDI)
timeFrame: 26 weeks
measure: Apathy Evaluation Scale (AES)
timeFrame: 26 weeks
measure: The Krupp Fatigue Severity Scale
timeFrame: 26 weeks
measure: The Parkinson's Disease Questionnaire is a Quality of Life(PDQ-39)
timeFrame: 26 weeks
measure: Adherence to Treatment
timeFrame: 12 weeks
measure: Clinical Global Impression of Change
timeFrame: 26 weeks
measure: Exit Questionnaire
timeFrame: 12 weeks
measure: Adverse Events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: Montreal General Hospital
name: Ronald Postuma, MD
role: PRINCIPAL_INVESTIGATOR
References: