PD Dance: Dancing with Parkinson's disease (PD)
| ISRCTN | ISRCTN63088686 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63088686 |
| Secondary identifying numbers | 13735 |
- Submission date
- 15/02/2013
- Registration date
- 19/02/2013
- Last edited
- 07/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
People with Parkinsons 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 Parkinsons disease who are interested in taking part and have been told about this study either
a) by a health professional
b) by their Parkinsons 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 Parkinsons disease, so that each person with Parkinsons 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 Parkinsons 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
Contact information
Scientific
School of Health Sciences
MP 886
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 2381 204584 |
|---|---|
| cjf1@soton.ac.uk |
Study information
| Study design | Randomised interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | ISRCTN63088686_PIS_05Mar13_V4.doc |
| Scientific title | Dancing with Parkinson's disease (PD): feasibility randomised controlled trial (RC) |
| Study acronym | PD Dance |
| Study objectives | 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. |
| Ethics approval(s) | NRES Committee South Central-Southampton A, 16/10/2012, ref:12/SC/0355 |
| Health condition(s) or problem(s) studied | Parkinson's disease |
| Intervention | Fifty-one PwP (People with Parkinsons) are randomised to control or experimental group in the ratio of 15:36. Intervention group: Each participant in the experimental group dances with their spouse, a friend or a volunteer. Three ballroom (Social Foxtrot, Waltz, tango) and 3 latin (Rumba, Cha Cha, Rock 'n' Roll) dances are taught by professional teachers in the DM dance centre. The dance classes last one hour twice a week for 10 weeks. Control group: Participants receive usual care. Usual care comprises of medication, attendance at medical clinics or visits from PD nurses. |
| Intervention type | Other |
| Primary outcome measure | 1. Spinal posture is measured using the Spinal Mouse at baseline, 3 and 6 months 2. Balance is assessed using the Berg Balance Scale at baseline, 3 and 6 months |
| Secondary outcome measures | 1. Turning quality is measured using Standing start 180° (SS180°) at baseline, 3 and 6 months 2. Quality of life is measured using the PDQ39 questionnaire at baseline, 3 and 6 months 3. Mobility is measured using The timed up and go test (TUG) at baseline, 3 and 6 months 4. Balance confidence when performing daily activities is measured using the ABC questionnaire at baseline, 3 and 6 months 5. Health status is measured using the EQ-5D questionnaire at baseline, 3 and 6 months 6. Participation and levels of physical activity is measured using The Phone-FITT questionnaire at baseline, 3 and 6 months 7. An economic evaluation is carried out using a resource use questionnaire at 6 months |
| Overall study start date | 01/08/2012 |
| Completion date | 31/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | We aim to recruit 50 people with Parkinsons 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. |
| Total final enrolment | 51 |
| Key inclusion criteria | Parkinsons disease: 1. Eligible people will have a confirmed diagnosis of Parkinsons 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 |
| Key exclusion criteria | Parkinsons 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. |
| Date of first enrolment | 20/02/2013 |
| Date of final enrolment | 17/01/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southampton
SO16 6YD
United Kingdom
Sponsor information
University/education
University of Southampton CTU
Mailpoint 816
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
| Phone | +44 23 8036 5044 |
|---|---|
| Danny.Pratt@uhs.nhs.uk | |
| Website | http://www.southampton.ac.uk/ |
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/07/2014 | Yes | No | |
| Participant information sheet | version V4 | 05/03/2013 | 24/03/2017 | No | Yes |
| Results article | qualitative results | 01/08/2018 | 07/08/2019 | Yes | No |
| Results article | results | 01/10/2017 | 07/08/2019 | Yes | No |
Additional files
- ISRCTN63088686_PIS_05Mar13_V4.doc
- Uploaded 24/03/2017
Editorial Notes
07/08/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added.
24/03/2017: The recruitment dates have been corrected from 01/08/2012 - 31/07/2014 to 20/02/2013 - 17/01/2014. In addition, the interventions and outcome measures have been added as well as the participant information sheet and IPD sharing plan.
