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

May 30, 2016 updated by: Joanne Shanahan, University of Limerick

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Munster
      • Limerick, Munster, Ireland
        • University of Limerick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Dance group
Participants allocated to this group will continue with their usual care and participate in a set dancing class.
Other: Dance group

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.
No Intervention: Control group
Participants allocated to this group will act as a control group and continue to receive their usual care only.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
This outcome measure will be assessed over a 1 year period from study inception to completion
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
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)
Time Frame: This outcome will be assessed during the 10 week set dancing intervention
2) Intervention will be considered successful if no adverse effects or safety issues are reported and attendance at classes is ≥70%
This outcome will be assessed during the 10 week set dancing intervention
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
This outcome will be assessed over a one year recruitment period
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
This outcome measure will be assessed over a 1 year period from study inception to completion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
This outcome will be assessed the week after the intervention period ends.
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
This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends
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
This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends
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
This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends
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
This outcome will be assessed within a week before the intervention begins and within a week after the intervention period ends

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Limerick

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Meg E Morris, Prof., Department of Physiotherapy, School of Allied Health, La Trobe University, Bundoora 3086, Australia.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ST2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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