Clinical trial NCT01757509: A Randomized Controlled Feasibility Trial to Determine the Effectiveness of Set Dancing for People With Parkinson's Disease
Official title: A Randomized Controlled Feasibility Trial to Determine the Effectiveness of Set Dancing for People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Set dancing
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2012-12-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate if set dancing is beneficial and feasible for those with Parkinson's disease in Ireland. The hypothesis of this feasibility study are that:

* Participants will be able to partake fully in the intervention without reporting adverse events.
* There will be evidence of gains in functional exercise tolerance, balance, motor performance and quality of life in those with Parkinson's disease who participate in eight weeks of set dancing classes compared to a control group.

Detailed description: Background: Previous research has found that people with Parkinson's disease who participate in dance classes have improved functional exercise capacity, mobility, balance and quality of life (Duncan and Earhart 2012; Hackney and Earhart 2009). Dance may be an effective intervention for people with Parkinson's disease as it targets key components of rehabilitation programmes for people with Parkinson's disease (Earhart 2009). These components include use of cueing strategies, training of muscle power and balance and focusing of attention on movement strategies.

The benefit of many forms of dance have being investigated in people with Parkinson's disease including Tango, (Hackney et al 2007), Contact Improvisation (Marchant et al 2010) and modern dance (Batson 2010). However, recently Irish set dancing has also being found to be beneficial for those with Parkinson's disease (Volpe et al 2013). Irish Set dancing may be beneficial for people with Parkinson's disease as it involves continuous movement initiation and cessation along with focusing of attention on body posture and foot placement. However, research to date has not been conducted in the Irish population. It is important to investigate if set dancing is beneficial for people with Parkinson's disease in Ireland as results may be influenced by the familiarity which the Irish population has for set dancing.

The objectives of the study are:

* To compare functional exercise tolerance, balance, motor performance and quality of life in those with Parkinson's disease before and after participating in set dancing classes, using the following validated outcome measures: Unified Parkinson's Disease Rating Scale 3, Berg Balance Scale, The Parkinson's Disease Questionnaire and The Six-Minute Walk Test.
* To compare functional exercise tolerance, balance, motor performance and quality of life in those with Parkinson's disease participating in set dancing classes to those receiving usual care.
* To assess the effect of the intervention on care giver burden using the Zarit Care Giver Burden Interview.

Participants, who meet inclusion/exclusion criteria, will be randomly assigned to a group who will receive a set dancing intervention along with their usual care or to a control group who will continue with their usual care only. Participants will be assessed the week before the intervention period begins and the week after the intervention period ends using valid and reliable outcome measures.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of idiopathic Parkinson's disease (Hackney et al 2007; Marchant et al 2010), stage 1-2.5 on the Hoeln and Yahr scale for staging of Parkinson's disease (Batson 2010)
* Showing a clear benefit from anti-Parkinson medication (Marchant et al 2010)
* Able to walk three meters with or without an assistive device (Hackney and Earhart 2009)
* Not pregnant
* Over 18 year of age
* Have a TV and DVD player in their own home to allow them to participate in the home exercise programme.

Exclusion Criteria:

* A serious cardiovascular and/or pulmonary condition (Lodder et al 2004)
* A neurological deficit other than Parkinson's disease (Batson 2010; Marchant et al 2010)
* Evidence of a musculoskeletal problem contraindicating participation in exercise participation(Duncan and Earhart 2012)
* A cognitive or hearing problem which will effect their ability to follow instructions or hear the music (Batson 2010)
* Participated in regular dance classes in the past six months (Marchant et al 2010)

Primary outcomes:
measure: Berg Balance Scale (To assess change in balance)
timeFrame: This outcome will be assessed the week before the intervention begins and the week after the intervention period ends.
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale 3 (UPDRS-3) (To assess changes in motor impairment)
timeFrame: This outcome will be assessed the week before the intervention begins and the week after the intervention period ends.
measure: The Parkinson's Disease Questionnaire (PDQ-39) (To assess change in health related quality of life)
timeFrame: This outcome will be assessed the week before the intervention begins and the week after the intervention period ends.
measure: Six-Minute Walk Test (To assess change of functional exercise tolerance)
timeFrame: This outcome will be assessed the week before the intervention begins and the week after the intervention period ends.
measure: Zarit Care Giver Burden Interview (ZCBI)(To assess changes in caregiver burden)
timeFrame: This outcome will be assessed the week before the intervention begins and the week after the intervention period ends.
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University of Limerick
state: Munster
Study officials:
affiliation: Department of Physiotherapy, School of Allied Health, La Trobe University, Bundoora 3086, Australia
name: Meg E Morris, Prof.
role: STUDY_CHAIR
References:
citation: Hackney ME, Earhart GM. Effects of dance on gait and balance in Parkinson's disease: a comparison of partnered and nonpartnered dance movement. Neurorehabil Neural Repair. 2010 May;24(4):384-92. doi: 10.1177/1545968309353329. Epub 2009 Dec 14.
citation: Hackney ME, Kantorovich S, Levin R, Earhart GM. Effects of tango on functional mobility in Parkinson's disease: a preliminary study. J Neurol Phys Ther. 2007 Dec;31(4):173-9. doi: 10.1097/NPT.0b013e31815ce78b.
citation: Marchant D, Sylvester JL, Earhart GM. Effects of a short duration, high dose contact improvisation dance workshop on Parkinson disease: a pilot study. Complement Ther Med. 2010 Oct;18(5):184-90. doi: 10.1016/j.ctim.2010.07.004. Epub 2010 Aug 21.