Therapeutic Dance in Parkinson's Disease: The UPbeating GReek Application of DancE in Parkinson's Disease (UPGRADE-PD) Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- University of West Attica
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in total score of Parkinson's Disease Questionnaire-8 (PDQ-8)
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Michail Elpidoforou
Principal Investigator
University of West Attica
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
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.
Minimum score 0, Maximum score 100. A higher score indicates worse quality of life.
Secondary Outcomes
- Change in total score of Parkinson Fatigue Scale-16 (PFS-16)(Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.)
- 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.)
- 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.)
- Change in total score of Modified Fatigue Impact Scale (MFIS)(Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.)
- Change in total score of Montreal Cognitive Assessment (MoCA)(Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.)
- Change in total score of Berg Balance Scale (BBS)(Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.)
- Registration of Music Preferences via Music Preferences Scale of Gardikiotis & Baltzis(Baseline (week 1))
- 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.)
- Change in total score of SARC-F Scale(Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.)
- Change in Body Mass Index(Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.)
- 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.)
- Changes in Frailty Phenotype (FP) status(Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.)
- 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.)