Parkinson DiseaseNCT05134506
Dance in Parkinson's Disease. A Greek Pilot Study
A study testing Dance for PD® classes in people with Parkinson Disease, run by University of West Attica at 1 site in Greece.
Trial summary
Dance for Parkinson's Disease® (DfPD®) is a structured dance program that has never been evaluated in Greek PD population. This study assesses for the first time the efficacy, safety and feasibility of DfPD® program in Greek PD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Dance for PD® classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGreece
- Study dates
- 28 May 2019to 31 Jul 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- An established diagnosis of idiopathic PD of an early-to-moderate severity; that is from 0 to 2,5 according to Hoehn and Yahr (H\&Y) stages
- Ability to understand, write and speak in Greek
- Written consent for participating into the study
Who cannot join
- A diagnosis of a non-PD tremor disorder
- Moderate-to-severe PD (≥3 H\&Y stages) due to a high falls risk
- Serious health or disability issues (either physical or mental) due of which exercise is not permitted and/or basic instructions during the program cannot be followed
- Mental disorder not related to PD
- Any disease other than PD which could affect mobility levels
Trial locations and contacts
1 site in 1 country.
Greece1 site
Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)
Athens, Attica, 12243
About this study
Official title: Effects of a Structured Dance Program in Parkinson's Disease. A Greek Pilot Study
Dance for Parkinson's Disease® (DfPD®) is a structured dance program that has never been evaluated in Greek PD population. This study assesses for the first time the efficacy, safety and feasibility of DfPD® program in Greek PD patients.
A total of 16 early-to-mid-stage PD patients underwent a total of 16 60-min classes of adjusted to Greek music and dance culture DfPD®, twice weekly, over 8 weeks. Assessments were performed at baseline and at the end of the study period and included quality of life, depressive symptoms, fatigue, cognitive functions, balance and body mass index. Safety and feasibility were also assessed.
Read the detailed description
Parkinson's Disease (PD) is an idiopathic, neurodegenerative, and progressive movement disorder caused mainly by dysfunction of dopaminergic cells of the substantia nigra. Numerous studies demonstrate the benefits of regular physical exercise in PD, with aerobic exercise having a greater neuroprotective effect by stimulating brain neuroplasticity. People with PD are more easily motivated to attend dance classes systematically than other forms of exercise, they have a high compliance rate with low dropouts, and often continue to practice dance outside the dance intervention.
DfPD® (Dance for Parkinson's Disease®, or Dance for PD®) was developed by the Brooklyn Parkinson Group (BPG) in collaboration with the Mark Morris Dance Group (MMDG) in 2001.This intervention has previously been shown to exert beneficial effect on QoL, motor functions, cognition, self-efficacy, anxiety and depression in people with PD. To the investigators' knowledge, there is no study investigating the effect of any structured dance program in Greek PD patients. Furthermore, no study to date has investigated the effect of DfPD® on PD patients' fatigue. The present pilot study aimed at evaluating for the first time the efficacy, safety and feasibility of a culturally adjusted DfPD® program in Greek patients with early-to-mid-stage PD.
This is a prospective, non-randomized, uncontrolled, open-label, pilot study. A total of 16 early-to-mid-stage PD patients underwent a total of 16 60-min classes of adjusted to Greek music and dance culture DfPD®, twice weekly, over 8 weeks. Assessments were performed at baseline and at the end of the study period and included quality of life, depressive symptoms, fatigue, cognitive functions, balance and body mass index. Safety and feasibility were also assessed.
- Conditions
- Parkinson Disease
- Being tested
- Dance for PD® classes
- Keywords
- Parkinson's Disease, Dance, Dance for Parkinson's, Quality of Life, Depression, Fatigue, Cognitive Functions
- Medical subject headings
- Parkinson Disease, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance for PD® classesBehavioural
The intervention consisted of 16 60-min classes, performed twice weekly over a period of 8 weeks and instructed by a single researcher who had the approval to use it for research reasons.
| Study group | Role | What they receive |
|---|---|---|
| Dance for PD® classes | Experimental | Dance for PD® was developed by the Brooklyn Parkinson Group (BPG) in collaboration with the Mark Morris Dance Group (MMDG) in 2001. It was designed to introduce people with PD to techniques used by dancers to control movement and it integrates different dance genres while participants dance individually and in groups rather than partnered. Receives: Behavioral: Dance for PD® classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total score of Parkinson's Disease Questionnaire-8
Minimum score 0, Maximum score 100. A higher score indicates worse quality of life.
Measured: Baseline (week 1), end of intervention (week 10)
Occurence of Emergent Adverse Events
Occurrence of adverse events comprising falls, injuries, muscle soreness or excessive fatigue.
Measured: During the intervention (week 2-9)
Financial Feasibility Assessment
No cost for the studio and the dance instructor.
Measured: During the intervention (week 2-9)
Adherence and Attrition Assessment
Adherence and attrition rates; an adherence rate ≥70% is considered as high in elderly with functional limitations, and attrition rate ≤15% is considered acceptable by the PEDro scale.
Measured: During the intervention (week 2-9)
Assessment of Willingness to Continue the Program after the Intervention
Verbal statement for continuing the program after the end of the intervention
Measured: End of intervention (week 10)
Assessment of Recruitment Rates
Target, up to 2 months for 16 participants.
Measured: Start of Recruitment (-3 months), Baseline (week 1)
Secondary outcomes (5)
Change in total score of Beck Depression Inventory-II
Minimum score 0, Maximum score 63. A higher score indicates worse depressive symptoms.
Measured: Baseline (week 1), end of intervention (week 10)
Change in total score of Parkinson Fatigue Scale-16
Minimum score 1, Maximum score 5. A higher score indicates more fatigue.
Measured: Baseline (week 1), end of intervention (week 10)
Change in total score of Montreal Cognitive Assessment
Minimum score is 0, Maximum score 30. Lower scores indicate cognitive impairment.
Measured: Baseline (week 1), end of intervention (week 10)
Change in total score of Berg Balance Scale
Minimum score is 0, Maximum score is 56. Lower scores indicate worse balance.
Measured: Baseline (week 1), end of intervention (week 10)
Change in Body Mass Index
Lower scores than 18,5 indicate underweight, scores of 18,5-24,9 indicate normal weight, scores of 25-29,9 indicate overweight and scores of over 30 indicate obesity.
Measured: Baseline (week 1), end of intervention (week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start28 May 2019
- Primary completion30 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of West Attica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michail Elpidoforou, University of West Attica
- Investigators
- Michail Elpidoforou, MSc, Principal investigator, Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134506
- Sponsor's protocol ID
- 296/24.4.2019
- Status last verified
- Nov 2021
- First submitted
- 16 Oct 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Structured Dance Program in Parkinson's Disease. A Greek Pilot Study
- ClinicalTrials.gov ID
- NCT05134506
- Acronym / sponsor ID
- 296/24.4.2019
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Dance, Dance for Parkinson's, Quality of Life, Depression, Fatigue, Cognitive Functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of West AtticaUniversity, hospital or other
- Study start
- 28 May 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 26 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.
Dance for Parkinson's Disease® (DfPD®) is a structured dance program that has never been evaluated in Greek PD population. This study assesses for the first time the efficacy, safety and feasibility of DfPD® program in Greek PD patients.
A total of 16 early-to-mid-stage PD patients underwent a total of 16 60-min classes of adjusted to Greek music and dance culture DfPD®, twice weekly, over 8 weeks. Assessments were performed at baseline and at the end of the study period and included quality of life, depressive symptoms, fatigue, cognitive functions, balance and body mass index. Safety and feasibility were also assessed.
Detailed description
Parkinson's Disease (PD) is an idiopathic, neurodegenerative, and progressive movement disorder caused mainly by dysfunction of dopaminergic cells of the substantia nigra. Numerous studies demonstrate the benefits of regular physical exercise in PD, with aerobic exercise having a greater neuroprotective effect by stimulating brain neuroplasticity. People with PD are more easily motivated to attend dance classes systematically than other forms of exercise, they have a high compliance rate with low dropouts, and often continue to practice dance outside the dance intervention.
DfPD® (Dance for Parkinson's Disease®, or Dance for PD®) was developed by the Brooklyn Parkinson Group (BPG) in collaboration with the Mark Morris Dance Group (MMDG) in 2001.This intervention has previously been shown to exert beneficial effect on QoL, motor functions, cognition, self-efficacy, anxiety and depression in people with PD. To the investigators' knowledge, there is no study investigating the effect of any structured dance program in Greek PD patients. Furthermore, no study to date has investigated the effect of DfPD® on PD patients' fatigue. The present pilot study aimed at evaluating for the first time the efficacy, safety and feasibility of a culturally adjusted DfPD® program in Greek patients with early-to-mid-stage PD.
This is a prospective, non-randomized, uncontrolled, open-label, pilot study. A total of 16 early-to-mid-stage PD patients underwent a total of 16 60-min classes of adjusted to Greek music and dance culture DfPD®, twice weekly, over 8 weeks. Assessments were performed at baseline and at the end of the study period and included quality of life, depressive symptoms, fatigue, cognitive functions, balance and body mass index. Safety and feasibility were also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dance for PD® classes | Experimental | Behavioral: Dance for PD® classesDance for PD® was developed by the Brooklyn Parkinson Group (BPG) in collaboration with the Mark Morris Dance Group (MMDG) in 2001. It was designed to introduce people with PD to techniques used by dancers to control movement and it integrates different dance genres while participants dance individually and in groups rather than partnered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- An established diagnosis of idiopathic PD of an early-to-moderate severity; that is from 0 to 2,5 according to Hoehn and Yahr (H\&Y) stages
- Ability to understand, write and speak in Greek
- Written consent for participating into the study
Key exclusion criteria (5 listed)
- A diagnosis of a non-PD tremor disorder
- Moderate-to-severe PD (≥3 H\&Y stages) due to a high falls risk
- Serious health or disability issues (either physical or mental) due of which exercise is not permitted and/or basic instructions during the program cannot be followed
- Mental disorder not related to PD
- Any disease other than PD which could affect mobility levels
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 |
|---|---|---|
| Dance for PD® classesThe intervention consisted of 16 60-min classes, performed twice weekly over a period of 8 weeks and instructed by a single researcher who had the approval to use it for research reasons. | Behavioural | Dance for PD® classes |
Primary outcome
Change in total score of Parkinson's Disease Questionnaire-8
Time frame: Baseline (week 1), end of intervention (week 10)
Minimum score 0, Maximum score 100. A higher score indicates worse quality of life.
Occurence of Emergent Adverse Events
Time frame: During the intervention (week 2-9)
Occurrence of adverse events comprising falls, injuries, muscle soreness or excessive fatigue.
Financial Feasibility Assessment
Time frame: During the intervention (week 2-9)
No cost for the studio and the dance instructor.
Adherence and Attrition Assessment
Time frame: During the intervention (week 2-9)
Adherence and attrition rates; an adherence rate ≥70% is considered as high in elderly with functional limitations, and attrition rate ≤15% is considered acceptable by the PEDro scale.
Assessment of Willingness to Continue the Program after the Intervention
Time frame: End of intervention (week 10)
Verbal statement for continuing the program after the end of the intervention
Assessment of Recruitment Rates
Time frame: Start of Recruitment (-3 months), Baseline (week 1)
Target, up to 2 months for 16 participants.
5 secondary outcomes
Change in total score of Beck Depression Inventory-II
Time frame: Baseline (week 1), end of intervention (week 10)
Change in total score of Parkinson Fatigue Scale-16
Time frame: Baseline (week 1), end of intervention (week 10)
Change in total score of Montreal Cognitive Assessment
Time frame: Baseline (week 1), end of intervention (week 10)
Change in total score of Berg Balance Scale
Time frame: Baseline (week 1), end of intervention (week 10)
Change in Body Mass Index
Time frame: Baseline (week 1), end of intervention (week 10)
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 26 Nov 2021.
- 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.
Michail Elpidoforou, MSc principal investigator
Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance for PD® classes in people with Parkinson Disease, run by University of West Attica at 1 site in Greece.
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 4 inclusion and 5 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 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Change in total score of Parkinson's Disease Questionnaire-8 (time frame: Baseline (week 1), end of intervention (week 10)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2021.