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Parkinson DiseaseUPGRADE-PDNCT06220084

The UPbeating GReek Application of DancE in Parkinson's Disease Clinical Trial

A study testing Dance for PD® in people with Parkinson Disease, run by University of West Attica at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Dance for Parkinson's Disease® (DfPD®) is a specially designed dance program for individuals with PD. This study assesses the efficacy, safety and feasibility of a culturally adapted DfPD® program offered both live and online 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®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteGreece
Study dates
2 May 2023to 31 Jul 2024
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 old
  • 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
  • Smart device (either smart phone or tablet/laptop/computer) access for the dance intervention which will be conducted remotely

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
  • Any electronic internal medical device or implant, such as a pacemaker or a deep brain stimulation, due to contraindication in the use of bio-electrical impedance analysis
  • No access of the participant or patient's carer to any smart device (either smart phone or tablet/laptop/computer)

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)

    Athens, Attica, 12243

Other trials in Greece

About this study

Official title: Therapeutic Dance in Parkinson's Disease: The UPbeating GReek Application of DancE in Parkinson's Disease (UPGRADE-PD) Clinical Trial

Dance for Parkinson's Disease® (DfPD®) is a specially designed dance program for individuals with PD. This study assesses the efficacy, safety and feasibility of a culturally adapted DfPD® program offered both live and online in Greek PD patients.

A total of 40 early-to-mid-stage PD Greek patients have been enrolled to underwent a total of 16 60-min classes twice weekly over 8 weeks both live and online as well as to be part of the non-intervention control group in a 3-arms crossover randomized controlled clinical trial. Assessments will be performed at baseline and at the end of each study period and will include quality of life, fatigue, depressive symptoms, stress, anxiety, sarcopenia, frailty, balance, cognitive functions, movement and non-movement PD symptoms, and Body Mass Index (BMI). Safety and feasibility of each of the dance interventions (live DfPD® vs remote DfPD®) will be assessed.

Read the detailed description

Parkinson's Disease (PD) is an idiopathic, neurodegenerative, and progressive movement disorder in which several types of physical exercise seem to have positive effects. Dance, as a form of organized physical activity, seems to more easily motivate PD patients to attend exercise classes with higher compliance rates and lower dropout rates in comparison with other means of exercise.

Dance for Parkinson's Disease® (DfPD®, or Dance for PD®) is a structured therapeutic dance program for people with PD designed by the Brooklyn Parkinson Group (BPG) and the Mark Morris Dance Group (MMDG) in 2001. The positive effect of the above program has been already shown for several factors, such as Quality of Life (QoL), motor functions, cognition, self-efficacy, anxiety, depression, and fatigue in PD patients. To our knowledge, there is no study investigating the effect of DfPD® on PD patients' frailty and sarcopenia. In addition, no randomized controlled clinical study to date has been conducted to investigate the effect of DfPD® on Greek PD patients to any parameter.

The main research purpose of that study is to investigate the possible positive effects of DfPD® in QoL, fatigue, depressive symptoms, stress, anxiety, sarcopenia, frailty, balance, cognitive functions, movement and non-movement PD symptoms, and Body Mass Index (BMI) of Greek Parkinson's individuals. The above scientific study is a 3-arms crossover randomized controlled clinical trial (live DfPD® vs remote DfPD® vs Control), and the experimental period will be of 10 months, including 3 periods of two months intervention of two 60min dance classes per week for each group (live DfPD® vs remote DfPD®) versus control group (non-intervention group) and 2 washout periods of two months between.

A total of 40 early-to-mid-stage PD Greek patients have been enrolled to underwent a total of 16 60-min classes twice weekly over 8 weeks both live and online as well as to be part of the non-intervention control group. Assessments will be performed at the baseline and at the end of each period (6 in total per individual) for each of the above parameters. Safety and feasibility will also be assessed.

Being tested
Dance for PD®
Keywords
Parkinson's Disease, Dance, Dance for Parkinson's, Quality of Life, Depression, Fatigue, Cognitive Functions, Stress, Anxiety, Frailty, Sarcopenia, Body Mass Index, Balance, Music Preferences
Medical subject headings
Parkinson Disease, Depression, Fatigue, Anxiety Disorders, Frailty, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dance for PD®Behavioural

    Also called Dance for Parkinson's®, DfPD®

    The intervention consists of 16 60-min adapted to Greek culture DfPD® classes, which will be performed twice weekly for 8 weeks and instructed by a single researcher, who has the approval to use it for research reasons. The intervention will be delivered both live and online in separate periods for each participant.

Study groups in NCT06220084
Study groupRoleWhat they receive
Live DfPD®ExperimentalEight weeks intervention of two 60min live dance classes per week plus their usual care
Receives: Behavioral: Dance for PD®
Remote DfPD®ExperimentalEight weeks intervention of two 60min online-via zoom platform dance classes per week plus their usual care
Receives: Behavioral: Dance for PD®
ControlNo interventionNon-interventional group in which participants receive their usual care only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in total score of Parkinson's Disease Questionnaire-8 (PDQ-8)

    Minimum score 0, Maximum score 100. A higher score indicates worse quality of life.

    Measured: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

Secondary outcomes (13)
  1. Change in total score of Parkinson Fatigue Scale-16 (PFS-16)

    Minimum score 1, Maximum score 5. A higher score indicates more fatigue.

    Measured: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

  2. Change in total score of Modified Fatigue Impact Scale (MFIS)

    Minimum score 0, Maximum score 84. A higher score indicates more fatigue.

    Measured: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

  3. Change in total score of Montreal Cognitive Assessment (MoCA)

    Minimum score 0, Maximum score 30. Lower scores indicate cognitive impairment.

    Measured: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

  4. Change in total score of Berg Balance Scale (BBS)

    Minimum score 0, Maximum score 56. Lower scores indicate worse balance.

    Measured: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

  5. Change in Depression Score of Depression, Anxiety and Stress Scale 21 (DASS-21)

    Normal score 0-9, Mild score: 10-12, Moderate score: 13-20, Severe score: 21-27, and Extremely severe: 28-42

    Measured: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

  6. Change in Anxiety Score of Depression, Anxiety and Stress Scale 21 (DASS-21)

    Normal score 0-6, Mild score: 7-9, Moderate score: 10-14, Severe score: 15-19, and Extremely severe: 20-42

    Measured: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

  7. Change in Stress Score of Depression, Anxiety and Stress Scale 21 (DASS-21)

    Normal score 0-10, Mild score: 11-18, Moderate score: 19-26, Severe score: 27-34, and Extremely severe: 35-42

    Measured: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

  8. Change in Patient Outcomes using the Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    MDS-UPDRS has 4 parts. Part I assesses non-motor experiences of daily living (13 items, score range: 0-52), part II assesses motor experiences of daily living (13 items, score range: 0-52), part III assesses motor signs (33 items, score range: 0-132), and part IV assesses motor complications, dyskinesias and motor fluctuations (6 items, score range: 0-24). Each item score ranges from 0 (normal) to 4 (severe) and higher scores indicate a greater impact of Parkinson's disease signs.

    Measured: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

  9. Change in total score of SARC-F Scale

    SARC-F is a self-reporting screening tool for the assess of the sarcopenia risk and comprises five components: strength, assistance walking, rise from a chair, climb stairs, and number of falls (score range: 0-2 for each component, and 0-10 in total. Healthy status score range: 0-3, risk of sarcopenia score: ≥4).

    Measured: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

  10. Change in Sarcopenia status using the European Working Group on Sarcopenia in Older People (EWGSOP2) criteria

    According to EWGSOP2, sarcopenia is (a) probable to an individual with low muscle strength (hand grip strength for men: <27 kg, and women: <16 kg), (b) confirmed to an individual with the above criteria plus low muscle quantity (appendicular skeletal muscle mass index for men: <7 kg/m^2, and women: <5,5 kg/m^2), and (c) severe to an individual with the two above criteria plus low physical performance (4-m usual walking speed test ≤0.8 m/s). Hand grip strength will be assessed by a calibrated digital handheld dynamometer, appendicular muscle mass index by a bioelectrical impedance analysis (BIA) equipment, and physical performance by the 4-min usual walking speed test.

    Measured: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

  11. Change in Body Mass Index

    A score from the equation kg/m^2. 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 equal or over 30 indicate obesity. Within the obesity category 3 subcategories exist: Class I scores of 30-34, Class II scores of 35-39, and Class III scores of ≥40.

    Measured: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

  12. Changes in Frailty Phenotype (FP) status

    According to the Fried FP, 5 criteria have to be assessed: unintentional weight loss >5 kg the last year, weakness (handgrip strength for men: <27 kg, and women: <16 kg), slow walking speed (10-m usual walking speed test ≤0.8 m/s), exhaustion (PFS-16 total score ≥3, which indicates moderate-to-severe fatigue), and low levels of physical activity (International Physical Activity Questionnaire-Short Form/IPAQ-SF total score <600 MET-min-week^-1, which indicates inactivity). The FP score ranges from 0 to 5 (1 point for each criteria; 0: best score to 5: worst score). As frail defined an individual with a score of ≥3, as pre-frail an individual with a score of 1-2, and as non-frail or robust an individual with a score 0.

    Measured: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.

  13. Registration of Music Preferences via Music Preferences Scale of Gardikiotis & Baltzis

    Music Preferences scale of Gardikiotis \& Baltzis is a 6-point Likert scale (0: i don't know it, 1: i don't like it at all to 5: i like it very much) of 24 items (each item includes a different music genre) and evaluates the individual's level of preference to a variety of Greek and non-Greek music.

    Measured: Baseline (week 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study start2 May 2023
  3. Primary completion11 Jul 2024 (estimated)
  4. Study completion31 Jul 2024 (estimated)

Resources

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
Randomised
Intervention model
Crossover
Model description
Groups: live DfPD® vs remote DfPD® vs Control. The experimental period will be of 10 months, including 3 periods of two months intervention for each group (live DfPD® vs remote DfPD®) versus control group (non-intervention group) and 2 washout periods of two months between.
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06220084
Sponsor's protocol ID
92282/10.10.2023
Other IDs
688/07.09.2022
Acronym
UPGRADE-PD
Status last verified
Jul 2024
First submitted
29 Dec 2023
Last updated
12 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Study protocol, statistical analysis plan, and clinical study report may be shared when results will be published in a Journal.

Publications

  • Elpidoforou M, Grimani I, Papadopoulou M, Papagiannakis N, Bougea A, Simitsi AM, Sfikas E, Alexandratou I, Alefanti I, Antonelou R, Koros C, Mavroyianni I, Chrysovitsanou C, Stefanis L, Bakalidou D. An In-Person and Online Intervention for Parkinson Disease (UPGRADE-PD): Protocol for a Patient-Centered and Culturally Tailored 3-Arm Crossover Trial. JMIR Res Protoc. 2025 May 2;14:e65490. doi: 10.2196/65490.

    PubMed 40314994

Questions about this trial

What is this clinical trial studying?

A study testing Dance for PD® 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Jul 2024. 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?

Results are not available in the source record.

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 (PDQ-8) (time frame: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.). 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 NCT06220084, which also lists 1 linked publication.

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 12 Jul 2024.

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