Clinical trial NCT06220084: The UPbeating GReek Application of DancE in Parkinson's Disease Clinical Trial
Official title: Therapeutic Dance in Parkinson's Disease: The UPbeating GReek Application of DancE in Parkinson's Disease (UPGRADE-PD) Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
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
Lead sponsor: University of West Attica
Sponsor class: OTHER
Collaborators: name: World in Harmony/Mundo en Armonia
First posted: 2024-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in total score of Parkinson's Disease Questionnaire-8 (PDQ-8)
timeFrame: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.
Secondary outcomes:
measure: Change in total score of Parkinson Fatigue Scale-16 (PFS-16)
timeFrame: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.
measure: Change in total score of Modified Fatigue Impact Scale (MFIS)
timeFrame: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.
measure: Change in total score of Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.
measure: Change in total score of Berg Balance Scale (BBS)
timeFrame: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.
measure: Change in Depression Score of Depression, Anxiety and Stress Scale 21 (DASS-21)
timeFrame: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.
measure: Change in Anxiety Score of Depression, Anxiety and Stress Scale 21 (DASS-21)
timeFrame: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.
measure: Change in Stress Score of Depression, Anxiety and Stress Scale 21 (DASS-21)
timeFrame: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.
measure: Change in Patient Outcomes using the Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.
measure: Change in total score of SARC-F Scale
timeFrame: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.
measure: Change in Sarcopenia status using the European Working Group on Sarcopenia in Older People (EWGSOP2) criteria
timeFrame: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.
measure: Change in Body Mass Index
timeFrame: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.
measure: Changes in Frailty Phenotype (FP) status
timeFrame: Baseline, 10 weeks, 19 weeks, 28 weeks, 37 weeks, and 46 weeks.
measure: Registration of Music Preferences via Music Preferences Scale of Gardikiotis & Baltzis
timeFrame: Baseline (week 1)
Other outcomes:
measure: Occurence of Adverse Events and Emergent Adverse Events
timeFrame: During the interventional periods (live DfPD® and remote DfPD®) for each participant.
measure: Adherence and Attrition Assessment
timeFrame: During the intervention (week 2-45)
measure: Assessment of Patient's Satisfaction
timeFrame: End of the program (week 45)
measure: Assessment of Recruitment Rates
timeFrame: Start of Recruitment (-6 months), Baseline (week 1)
Locations:
city: Athens
country: Greece
facility: Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)
state: Attica
Study officials:
affiliation: Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)
name: Michail Elpidoforou, MSc
role: PRINCIPAL_INVESTIGATOR
References: