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Completed

NCT Number: NCT01939717

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Limerick

Limerick, Munster, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

DANCE GROUP

Other

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.

Primary outcomes

  1. 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

  2. Attrition (To assess dropout rate during the study)

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

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

  3. Intervention adherence (To assess compliance with the dance intervention)

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

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

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

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

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

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

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

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

Secondary outcomes

  1. Exit Questionnaire (To assess participants satisfaction)

    Time frame: This outcome will be assessed the week after the intervention period ends.

    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).

  2. The Parkinson's Disease Questionnaire (PDQ-39) (To assess change in health related quality of life)

    Time frame: This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends

    Self-report quality of life questionnaire

  3. Unified Parkinson's Disease Rating Scale 3 (UPDRS-3) (To assess changes in motor impairment)

    Time frame: This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends

    Disease specific measure of motor function

  4. Six minute walk test (To assess change in functional endurnace)

    Time frame: This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends

    Measure of functional endurance

  5. MiniBESTest (To asses change in balance)

    Time frame: This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends

    Balance measure

Sponsors and collaborators

Lead sponsor

University of Limerick

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 11, 2013
Registry last updated
Jun 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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