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

NCT ID: NCT06220084

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2024-07-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Live DfPD®

Eight weeks intervention of two 60min live dance classes per week plus their usual care

Group Type: EXPERIMENTAL

Dance for PD®

Intervention Type: BEHAVIORAL

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.

Remote DfPD®

Eight weeks intervention of two 60min online-via zoom platform dance classes per week plus their usual care

Group Type: EXPERIMENTAL

Dance for PD®

Intervention Type: BEHAVIORAL

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.

Control

Non-interventional group in which participants receive their usual care only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dance for PD®

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Dance for Parkinson's®, DfPD®

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

World in Harmony/Mundo en Armonia

UNKNOWN

Sponsor Role: collaborator

University of West Attica

OTHER

Sponsor Role: lead

Responsible Party

Michail Elpidoforou

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michail Elpidoforou, MSc

Role: PRINCIPAL_INVESTIGATOR

Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)

Locations

Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM)

Athens, Attica, Greece

Countries

Greece

References

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.

Reference Type: DERIVED

PMID: 40314994 (View on PubMed)

Other Identifiers

688/07.09.2022

Identifier Type: REGISTRY

Identifier Source: secondary_id

92282/10.10.2023

Identifier Type: -

Identifier Source: org_study_id