The UPbeating GReek Application of DancE in Parkinson's Disease Clinical Trial
- Conditions
- Parkinson Disease
- Interventions
- Behavioral: Dance for PD®
- Registration Number
- NCT06220084
- Lead Sponsor
- University of West Attica
- Brief 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.
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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Live DfPD® Dance for PD® Eight weeks intervention of two 60min live dance classes per week plus their usual care Remote DfPD® Dance for PD® Eight weeks intervention of two 60min online-via zoom platform dance classes per week plus their usual care
- Primary Outcome Measures
Name Time Method Change in total score of Parkinson's Disease Questionnaire-8 (PDQ-8) Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. Minimum score 0, Maximum score 100. A higher score indicates worse quality of life.
- Secondary Outcome Measures
Name Time Method Change in total score of Parkinson Fatigue Scale-16 (PFS-16) Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. Minimum score 1, Maximum score 5. A higher score indicates more fatigue.
Change in Depression Score of Depression, Anxiety and Stress Scale 21 (DASS-21) Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. Normal score 0-9, Mild score: 10-12, Moderate score: 13-20, Severe score: 21-27, and Extremely severe: 28-42
Change in Stress Score of Depression, Anxiety and Stress Scale 21 (DASS-21) Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. Normal score 0-10, Mild score: 11-18, Moderate score: 19-26, Severe score: 27-34, and Extremely severe: 35-42
Change in total score of Modified Fatigue Impact Scale (MFIS) Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. Minimum score 0, Maximum score 84. A higher score indicates more fatigue.
Change in total score of Montreal Cognitive Assessment (MoCA) Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. Minimum score 0, Maximum score 30. Lower scores indicate cognitive impairment.
Change in total score of Berg Balance Scale (BBS) Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. Minimum score 0, Maximum score 56. Lower scores indicate worse balance.
Registration of Music Preferences via Music Preferences Scale of Gardikiotis & Baltzis Baseline (week 1) 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.
Change in Anxiety Score of Depression, Anxiety and Stress Scale 21 (DASS-21) Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. Normal score 0-6, Mild score: 7-9, Moderate score: 10-14, Severe score: 15-19, and Extremely severe: 20-42
Change in total score of SARC-F Scale Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. 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).
Change in Body Mass Index Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. 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.
Change in Patient Outcomes using the Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. 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.
Changes in Frailty Phenotype (FP) status Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. 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.
Change in Sarcopenia status using the European Working Group on Sarcopenia in Older People (EWGSOP2) criteria Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks. 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.
Trial Locations
- Locations (1)
Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)
🇬🇷Athens, Attica, Greece