Condition category
Nervous System Diseases
Date applied
15/02/2013
Date assigned
19/02/2013
Last edited
24/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People with Parkinson’s Disease (PwPD) are likely to become less steady, less able to move around inside their homes and outside in the community and more prone to falls as the condition progresses. Balance training exercises such as reaching forwards and sideways as far as possible in sitting and standing, turning round and standing up from sitting help to improve steadiness. Limited resources within the NHS led us to consider novel ways of helping PwPD to maintain safe balance control and walking in addition to their normal health care. We propose that a large trial is needed to find out if it is appropriate to encourage PwPD to participate in a community-based dance classes. We aim to test the acceptability and appropriateness of recruiting people with mild to moderate PD and randomly allocating them to receiving usual care or usual care plus a dance class. We have designed a study of 50 people with PD. The study will inform us about the practicalities and appropriateness of PwPD participating in community-based dance classes, the best ways of recruiting PwPD and partners, providing access to dance and the most effective research procedures. Most of this information has not been recorded in the few published papers on this topic. Our findings will provide unique information about the position and movement of the spine, balance control, turning, walking, quality of life, fall frequency and the best ways of collecting information for evaluating the cost benefit. We will ask people to talk about their personal insights and experiences of dance and explore their views about the appropriateness of the activity. The main objective of the study is to provide a basis from which a future larger trial can be effectively planned. The research team has considerable experience in physiotherapy for PwPD with balance problems; one member has a professional qualification as a dance teacher and is a consultant physiotherapist.

Who can participate?
People diagnosed with Parkinson’s disease who are interested in taking part and have been told about this study either
a) by a health professional
b) by their Parkinson’s disease support group
c) if you have previously agreed that we could inform you of further research taking place at the University of Southampton or with the local research network
d) as a result of your response to an advert.

What does the study involve?
We are planning to recruit 50 people with PD; thirty-five of whom will be randomly allocated to attend a dance class at a local dance centre and 15 will be in a comparison group who will not attend the dance class. We propose to recruit 35 healthy individuals to form dance couples with people with Parkinson’s disease, so that each person with Parkinson’s disease has a healthy dance partner. The study will inform us about the practicalities and appropriateness of PwPD participating in community-based dance classes, the best ways of inviting PwPD and finding dance partners, providing access to dance and the most effective research procedures. We will also ask some of you to tell us about your experiences of taking part in the dance study. This will involve an additional interview at the end of the study.

What are the possible benefits and risks of participating?
There will be no direct benefit to you from taking part in the study although you might enjoy learning new dance steps and being more active. However it is hoped that the data collected may allow us to find out if dance classes are a good way to improve the balance, posture and turning of people with Parkinson’s disease. This information can then be used to set up a larger trial to see if different forms of rehabilitation such as dancing are effective. Answering questions from questionnaires can sometimes cause distress. You do not have to answer any question you do not wish to answer and we can stop the questions at any point. It is possible that taking part in dance classes can cause instability and put you off balance. To minimize the risk of falling, you are teamed up with a healthy dance partner to aid stability and you will only be taught dance steps that are based on your individual capabilities. You do not have to practice any dance steps you feel unsure about. A qualified dance teacher and a research assistant will be present during the dance sessions to help ensure your safety. A first aider will be on hand to give appropriate treatment as required.

Where is the study run from?
The University of Southampton

When is the study starting and how long is it expected to run for?
The project started on 1 August 2012 and will run until July 2014.

Who is funding the study?
The study is funded by the NIHR Research for Patient Benefit Programme

Who is the main contact?
Professor Ann Ashburn
ann@soton.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Carolyn Fitton

ORCID ID

Contact details

School of Health Sciences
MP 886
Tremona Road
Southampton
SO16 6YD
United Kingdom
cjf1@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13735

Study information

Scientific title

Dancing with Parkinson's disease (PD): feasibility randomised controlled trial (RC)

Acronym

PD Dance

Study hypothesis

We propose that a large trial is needed to find out if it is appropriate to encourage PwPD (people with Parkinson's Disease) to participate in community based dance classes. We aim to test the acceptability and appropriateness of recruiting people with mild to moderate PD and randomly allocating them to receiving usual care or usual care plus a dance class. We have designed a study of 50 people with PD. The study will inform us about the practicalities and appropriateness of PwPD participating in community-based dance classes, the best ways of recruiting PwPD and partners, providing access to dance and the most effective research procedures. Most of this information has not been recorded in the few published papers on this topic. Our findings will provide unique information about the position and movement of the spine, balance control, turning, walking, quality of life, fall frequency and the best ways of collecting information for evaluating the cost benefit. We will ask people to talk about their personal insights and experiences of dance and explore their views about the appropriateness of the activity. The main objective of the study is to provide a basis from which a future larger trial can be effectively planned. The research team has considerable experience in physiotherapy for PwPD with balance problems; one member has a professional qualification as a dance teacher and is a consultant physiotherapist.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13735

Ethics approval

NRES Committee South Central-Southampton A, 16th October 2012, ref:12/SC/0355

Study design

Randomised interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Parkinson's disease

Intervention

Ballroom dancing, Dancing twice a week for 10 weeks

Usual care

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Measure spinal posture and balance; Timepoint(s): Base Line assessment and follow up assessments at 3 months and 6 months

Secondary outcome measures

1. Health economics; Timepoint(s): Baseline assessment and followed by assessments and 3 and 6 months
2. Qualitative interview; Timepoint(s): At 3 months
3. Walking, Turning, Balance confidence, self reported measure of PD specific health status; Timepoint(s): Base line assessments followed by assessment at 3 and 6 months

Overall trial start date

01/08/2012

Overall trial end date

31/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Parkinson’s disease:
1. Eligible people will have a confirmed diagnosis of Parkinson’s disease, Hoehn & Yahr scale of 2 or 3, which means mild to moderate mobility and stability
2. Live at home
3. Understand and follow commands; pass screen for cognitive impairment
4. Agree they can tolerate the dance activity (1 hour session, twice a week for 10 weeks with practice)

Healthy partners: Healthy people identified by eligible participants with PD will be considered for the trial. Some PwPD will be single and others will have a spouse unwilling to participate therefore relatives, volunteers or responders to an advert will also be considered. The feasibility of recruiting healthy dance partners will be examined in the study. Our criteria are:
1. Similar age
2. Able to understand and follow commands
3. Willing to participate and able to tolerate the dance activity (1 hour session, twice a week for 10 weeks with practice)
4. Target Gender: Male & Female; Upper Age Limit 99 years ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

We aim to recruit 50 people with Parkinson’s disease. 35 of these will be randomised to a dance group and 15 to a control group. 35 healthy adults will be recruited as dance partners.

Participant exclusion criteria

Parkinson’s disease: Those individuals who lack sufficient stability to dance with another person (clinical judgement)

Healthy partners: Evidence of a neurological condition, vestibular impairment or multiple falls would lead to exclusion but experience of a single fall would be acceptable. Individuals who are at risk of instability when dancing will be excluded.

Recruitment start date

01/08/2012

Recruitment end date

31/07/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Health Sciences
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

University of Southampton CTU
Mailpoint 816
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Danny.Pratt@uhs.nhs.uk

Sponsor type

University/education

Website

http://www.southampton.ac.uk/

Funders

Funder type

Government

Funder name

NIHR (UK) - Central Commissioning Facility; Grant Codes: RHM HOS0213

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25051989

Publication citations

  1. Protocol

    Ashburn A, Roberts L, Pickering R, Roberts HC, Wiles R, Kunkel D, Hulbert S, Robison J, Fitton C, A design to investigate the feasibility and effects of partnered ballroom dancing on people with Parkinson disease: randomized controlled trial protocol., JMIR Res Protoc, 2014, 3, 3, e34, doi: 10.2196/resprot.3184.

Additional files

Editorial Notes