Parkinson Disease(PD)NCT05113524
Effects of Dance on the Turning Characteristics of Patients With Parkinson's Disease
A study testing Dance in people with Parkinson Disease(PD), run by Federal University of Rio Grande do Sul at 2 sites in 2 countries.
Trial summary
The proposed control intervention trial, aims to analyse the effects of Dance in the turning characteristics in patients with Parkinson Disease (PD) using three- dimensional (3D) analysis during the timed up and go (TUG) test. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease(PD)
- What is being tested?
- Dance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Dec 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of PD according to the London Brain Bank Criteria;
- Able to understand the verbal instructions for the tests and to walk;
- Or attempt to walk independently with no walking aid.
Who cannot join
- Recent surgeries,
- Deep brain stimulation (DBS);
- Severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year;
- Fitted with a pacemaker;
- Prostheses in the lower limbs;
- Stroke or other associated neurological diseases.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
University of Wolverhampton, Walsall Campus
Walsall, West Midlands, WS1 3BD
About this study
Official title: The Effects of Dance on the Turning Characteristics of Patients With Parkinson's Disease During the Timed up and Go Test
The proposed control intervention trial, aims to analyse the effects of Dance in the turning characteristics in patients with Parkinson Disease (PD) using three- dimensional (3D) analysis during the timed up and go (TUG) test.
Read the detailed description
Experimental Design: control intervention non-randomized trial. Search Location: University of Wolverhaptom, Walsall Campus, United Kingdom; Federal University of Rio Grande do Sul, Brazil.
Participants: 15 adults aged between 50 and 80 years, with a clinical diagnosis of idiopathic PD, staging between 1 and 4 of the Hoehn \& Yahr Scale, recruited from Dance for Parkinson's Projects, West-Midlands County, United Kingdom, and from Parkinson's UK (United Kingdom).
Interventions: Dance intervention for 3 months, 2 times/week (1 instructor lecture session and 1 home session following a prepared video), 2 hours per week. Controls, not alter their personal lifestyle, but undergo the same testing as the exercise intervention group.
Outcomes: clinical-functional parameters (number of steps and total time of the 180 turning phase of the Timed up and go Test - TUG - and biomechanics parameter - girdle dissociation) Data Analysis: Data will be described by average values and standard deviation values. All statistical analyses will be carried out using SPSS version 23, and Microsoft Excel Program version 16.44. The significance level is set at p<0.05. The Cohen's d is going to be used to predict effect interpreted as small d= 0.2, medium d=0.5, and large d=0.8, and 95% confidence intervals were presented.
- Conditions
- Parkinson Disease(PD)
- Being tested
- Dance, No intervention
- Keywords
- Dance, Functional Mobility, Turning
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DanceOther
The dance program consists of 3 months of dance classes. Classes are specifically designed for people with Parkisnon's and lead by a qualified dance instructor experienced in teaching this population. The in-person dance classes are conducted in an appropriate room with chairs and ballet barres once a week. In addition, the participants received a CD containing a video of the recorded dance routine to be performed at home once a week. The class typically included a warm-up (10-15 min.), barre ballet exercises (10-15 min.), general dance-related activities (15-20 min), and a cool-down (10-15 min).
No interventionOther
Controls, not alter their personal lifestyle, but will undergo the same testing as the exercise intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Dance | Experimental | Dance intervention for 3 months, 2 times/week (1 instructor lecture session and 1 home session following a prepared video), 2 hours per week. Dance is a safe and effective form of activity, which has been used in PD population (Delabary et al., 2017; Sharp and Hewitt, 2014). Participants take part in a dance class specifically for people with PD lead by a qualified dance instructor. The dance class typically include a warm-up, dance related activities (specific to the genre of the class) and a cool-down. Receives: Other: Dance |
| Control Group | Active comparator | Controls, not alter their personal lifestyle, but undergo the same testing as the exercise intervention group. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
180 turning phase of the Timed up and go Test (TUG)
The beginning of the turning phase started from the last heel-strike of the regular straight line walking pattern. The end of the turn was the final heel-off at the end of the turning motion, where the participant was ambulating in the opposite direction and prior to the cyclic straight line gait pattern resuming. The exact time points were taken from the peak anterior-posterior linear velocity of the lower leg data corresponding with the specific heel-strike and heel-off instances. The number of steps and the total time taken to complete the 180 turning phase of the TUG test were measured.
Measured: Change from baseline at 3 months
Secondary outcomes (1)
Girdle dissociation
The girdle dissociation is a selected biomechanics parameter. To obtain the value for the girdle dissociation, the difference between the orientation of the pelvis and the affected shoulder in the transverse plane, was calculated for each data point throughout the 180 turning phase of the TUG test. The range between the maximum and minimum dissociation angles was reported and further analysed.
Measured: Change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start10 Dec 2018
- Primary completion1 May 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson Disease(PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wolverhampton, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Aline Nogueira Haas, Federal University of Rio Grande do Sul
- Investigators
- Aline Nogueira Haas, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113524
- Sponsor's protocol ID
- 33547920.9.0000.5347
- Other IDs
- 12/18/NH/UOW
- Status last verified
- May 2022
- First submitted
- 28 Oct 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dos Santos Delabary M, Komeroski IG, Monteiro EP, Costa RR, Haas AN. Effects of dance practice on functional mobility, motor symptoms and quality of life in people with Parkinson's disease: a systematic review with meta-analysis. Aging Clin Exp Res. 2018 Jul;30(7):727-735. doi: 10.1007/s40520-017-0836-2. Epub 2017 Oct 4.
PubMed 28980176Dos Santos Delabary M, Monteiro EP, Donida RG, Wolffenbuttel M, Peyre-Tartaruga LA, Haas AN. Can Samba and Forro Brazilian rhythmic dance be more effective than walking in improving functional mobility and spatiotemporal gait parameters in patients with Parkinson's disease? BMC Neurol. 2020 Aug 18;20(1):305. doi: 10.1186/s12883-020-01878-y.
PubMed 32811464
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dance on the Turning Characteristics of Patients With Parkinson's Disease During the Timed up and Go Test
- ClinicalTrials.gov ID
- NCT05113524
- Acronym / sponsor ID
- 33547920.9.0000.5347
- Conditions
- Parkinson Disease(PD)
- Keywords
- Dance, Functional Mobility, Turning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- University of Wolverhampton, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed control intervention trial, aims to analyse the effects of Dance in the turning characteristics in patients with Parkinson Disease (PD) using three- dimensional (3D) analysis during the timed up and go (TUG) test.
Detailed description
Experimental Design: control intervention non-randomized trial. Search Location: University of Wolverhaptom, Walsall Campus, United Kingdom; Federal University of Rio Grande do Sul, Brazil.
Participants: 15 adults aged between 50 and 80 years, with a clinical diagnosis of idiopathic PD, staging between 1 and 4 of the Hoehn \& Yahr Scale, recruited from Dance for Parkinson's Projects, West-Midlands County, United Kingdom, and from Parkinson's UK (United Kingdom).
Interventions: Dance intervention for 3 months, 2 times/week (1 instructor lecture session and 1 home session following a prepared video), 2 hours per week. Controls, not alter their personal lifestyle, but undergo the same testing as the exercise intervention group.
Outcomes: clinical-functional parameters (number of steps and total time of the 180 turning phase of the Timed up and go Test - TUG - and biomechanics parameter - girdle dissociation) Data Analysis: Data will be described by average values and standard deviation values. All statistical analyses will be carried out using SPSS version 23, and Microsoft Excel Program version 16.44. The significance level is set at p<0.05. The Cohen's d is going to be used to predict effect interpreted as small d= 0.2, medium d=0.5, and large d=0.8, and 95% confidence intervals were presented.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dance | Experimental | Other: DanceDance intervention for 3 months, 2 times/week (1 instructor lecture session and 1 home session following a prepared video), 2 hours per week. Dance is a safe and effective form of activity, which has been used in PD population (Delabary et al., 2017; Sharp and Hewitt, 2014). Participants take part in a dance class specifically for people with PD lead by a qualified dance instructor. The dance class typically include a warm-up, dance related activities (specific to the genre of the class) and a cool-down. |
| Control Group | Active comparator | Other: No interventionControls, not alter their personal lifestyle, but undergo the same testing as the exercise intervention group. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of PD according to the London Brain Bank Criteria;
- Able to understand the verbal instructions for the tests and to walk;
- Or attempt to walk independently with no walking aid.
Key exclusion criteria (6 listed)
- Recent surgeries,
- Deep brain stimulation (DBS);
- Severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year;
- Fitted with a pacemaker;
- Prostheses in the lower limbs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DanceThe dance program consists of 3 months of dance classes. Classes are specifically designed for people with Parkisnon's and lead by a qualified dance instructor experienced in teaching this population. The in-person dance classes are conducted in an appropriate room with chairs and ballet barres once a week. In addition, the participants received a CD containing a video of the recorded dance routine to be performed at home once a week. The class typically included a warm-up (10-15 min.), barre ballet exercises (10-15 min.), general dance-related activities (15-20 min), and a cool-down (10-15 min). | Other | Dance |
| No interventionControls, not alter their personal lifestyle, but will undergo the same testing as the exercise intervention group. | Other | Control Group |
Primary outcome
180 turning phase of the Timed up and go Test (TUG)
Time frame: Change from baseline at 3 months
The beginning of the turning phase started from the last heel-strike of the regular straight line walking pattern. The end of the turn was the final heel-off at the end of the turning motion, where the participant was ambulating in the opposite direction and prior to the cyclic straight line gait pattern resuming. The exact time points were taken from the peak anterior-posterior linear velocity of the lower leg data corresponding with the specific heel-strike and heel-off instances. The number of steps and the total time taken to complete the 180 turning phase of the TUG test were measured.
1 secondary outcome
Girdle dissociation
Time frame: Change from baseline at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Background: PubMed 28980176Dos Santos Delabary M, Komeroski IG, Monteiro EP, Costa RR, Haas AN. Effects of dance practice on functional mobility, motor symptoms and quality of life in people with Parkinson's disease: a systematic review with meta-analysis. Aging Clin Exp Res. 2018 Jul;30(7):727-735. doi: 10.1007/s40520-017-0836-2. Epub 2017 Oct 4.
- Background: PubMed 32811464Dos Santos Delabary M, Monteiro EP, Donida RG, Wolffenbuttel M, Peyre-Tartaruga LA, Haas AN. Can Samba and Forro Brazilian rhythmic dance be more effective than walking in improving functional mobility and spatiotemporal gait parameters in patients with Parkinson's disease? BMC Neurol. 2020 Aug 18;20(1):305. doi: 10.1186/s12883-020-01878-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aline Nogueira Haas, PhD principal investigator
Federal University of Rio Grande do Sul
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance in people with Parkinson Disease(PD), run by Federal University of Rio Grande do Sul at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
180 turning phase of the Timed up and go Test (TUG) (time frame: Change from baseline at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05113524, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.