A Randomized Controlled Pilot Trial Comparing Irish Set Dancing to Usual Care for People With Parkinson's Disease

N/ACompletedNCT01939717

University of Limerick90 enrolled

Overview

Primary aim is to conduct a pilot trial to determine: 1. The feasibility and efficiency of randomisation procedures and study design 2. If recruitment rates are sufficient to adequately power a larger trial The secondary aim is to determine the efficiency of set dancing in comparison to a control for people with Patkinson's disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Parkinson's Disease

Interventions

Dance groupOTHER

Participants will attend ten weeks of set dancing classes. Each class will be one and half hours. Family members will be invited to partner each participant with Parkinson's disease during the class. Set dancing steps and sets will be thought and progressed in line with the participants abilities. Frequent rests will be taken during the classes. Participants will be given a home exercise programme which will involve chair based exercises, mental rehearsal, listening music, watching a dance DVD and practicing dance material thought in class.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have a diagnosis of idiopathic Parkinson's disease (Hackney et al 2007; Marchant et al 2010), stage 1-2.5 on the modified Hoeln and Yahr scale for staging of Parkinson's disease (Batson 2010) * Able to walk three meters with an assistive device * Over 18 years of age * Not pregnant * Have access to a computer/DVD player 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 (Duncan and Earhart 2012), contraindicating participation in exercise participation(Lodder et al 2004) * A cognitive or hearing problem which will affect 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)

Locations (1)

University of Limerick

Limerick, Munster, Ireland

Outcomes

Primary Outcomes

Feasibility of randomization procedures (To assess implementation of randomization procedures)

Time frame: This outcome measure will be assessed over a 1 year period from study inception to completion

Attrition (To assess dropout rate during the study)

Attrition rate of ≤ 20% per group will be deemed acceptable

Time frame: This outcome measure will be assessed over a 1 year period from study inception to completion

Intervention adherence (To assess compliance with the dance intervention)

2\) Intervention will be considered successful if no adverse effects or safety issues are reported and attendance at classes is ≥70%

Time frame: This outcome will be assessed during the 10 week set dancing intervention

Recruitment rates (To assess rate, duration and success of recruitment methods)

Recruitment considered successful and feasible is 100 participants are recruited in one year

Time frame: This outcome will be assessed over a one year recruitment period

Resources (To assess availability of personnel and building needed to implement study methodology)

Document issues regarding availability of personnel or buildings needed to implement study methodology

Time frame: This outcome measure will be assessed over a 1 year period from study inception to completion

Secondary Outcomes

Exit Questionnaire (To assess participants satisfaction)

The exit questionnaire will assess participants' satisfaction with the dance intervention at the end of the study. The questionnaire asks participants if they have noted improvements in different aspects of physical well-being, and allows feedback relating to the structure, material and enjoyment of the dance classes to be gathered. This questionnaire has previously been used in other studies investigating the benefit of dance for those with Parkinson's disease (Hackney and Earhart 2009; Hackney and Earhart 2010).

Data from ClinicalTrials.gov

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