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

Parkinson's Disease Clinical Trial

Official title:

Tango for Treatment of Motor and Non-motor Manifestations in Parkinson's Disease: A Randomized Control Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01573260
• Other study ID #: GEN-11-261
• Status: Completed
• Phase: Phase 0
• First received: April 5, 2012
• Last updated: December 21, 2015
• Start date: April 2012
• Est. completion date: April 2014

Study information

• Verified date: December 2015
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of PD (Unified Parkinson Disease Rating Scale - UPDRS, 2008 Version)	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)	26 weeks	No
Secondary	MiniBESTest	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.	26 weeks	No
Secondary	Number of Participants With a Fall in the Past 3 Months Using the Falls Questionnaire From the Canadian Longitudinal Study of Aging	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.	26 weeks	No
Secondary	Freezing of Gait Questionnare (FOG_Q)	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).	26 weeks	No
Secondary	The Purdue Pegboard	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.	26 weeks	No
Secondary	The Montreal Cognitive Assessment	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)"	26 weeks	No
Secondary	The Beck Depression Inventory (BDI)	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)"	26 weeks	No
Secondary	Apathy Evaluation Scale (AES)	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).	26 weeks	No
Secondary	The Krupp Fatigue Severity Scale	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).	26 weeks	No
Secondary	The Parkinson's Disease Questionnaire is a Quality of Life(PDQ-39)	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).	26 weeks	No
Secondary	Adherence to Treatment	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.	12 weeks	No
Secondary	Clinical Global Impression of Change	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).	26 weeks	Yes
Secondary	Exit Questionnaire	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.	12 weeks	Yes
Secondary	Adverse Events	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	12 weeks	Yes