PD-Ballet: Effectiveness and Implementation in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Efficacy of Ballet Dancing on Motor and Non-motor Symptoms of Parkinson's Disease: a Hybrid Type 2 Effectiveness-implementation Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04719468
• Other study ID #: 275588
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: April 2021
• Source: King's College Hospital NHS Trust
• Contact: Aleksandra Podlewska, MSc
• Phone: 02032997189
• Email: aleksandra.podlewska[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Current literature consistently demonstrates beneficial motor effects of dance-based therapies in Parkinson's disease, along with improved quality of life. Little is known about the non-motor gains following such therapy. To date, no RTC has been conducted to investigate the benefits of ballet dancing in Parkinson's disease.

The investigators aim to recruit 160 people with Parkinson's to either: participate in a 12-week ballet-based dancing intervention followed by a 'social Tea and Biscuit' session, or 12-week usual treatment monitoring and 'social Tea and Biscuit' sessions taking place after each intervention session. This study employs a randomised, controlled, single-blind, hybrid type 2 design with a hybrid implementation protocol to investigate both clinical efficacy of the programme and implementation aspects. The project's primary outcome measure is centered around non-motor symptoms of PD. Other measures include motor assessments, wearable sensors and quality of life assessments.

Due to COVID-19 pandemic, the delivery of the sessions will be a hybrid model - virtual sessions will be the primary method, with some capacity for in-person delivery when possible and deemed safe.

Description:

Parkinson's Disease is a neurodegenerative condition currently affecting over 120,000 people in the UK and this number is set to double by 2065. The current treatment is based around symptomatic pharmacotherapy with levodopa being the gold standard. Currently there is some evidence for non-pharmacological treatments outlined by NICE guidelines, with no recommendations to specific adjuvant non-pharmacotherapies to aid PD symptoms, other than referral for physiotherapy. However, physical exercise has been shown to improve balance, strength, coordination and gait, leading to a significant improvement in quality of life.

While a clear benefit of physical exercise on the motor symptoms is evident, few studies to date focused on the effects of group classes and on non-motor effects. Dance is emerging as a therapeutic option with cognitive, functional and psychosocial benefits, due to it being a multi-dimensional activity offering auditory, visual and sensory stimulation, musical experience, social interaction, memory, motor learning and emotional perception, expression and interaction and as such stimulating multiple pathways. To date, no research has explored acute and chronic effects of exercise based interventions (such as dance therapy with ballet) in comparison to the conventional therapy-based management of Parkinson's.

This is a randomised, controlled, single-blind study involving 160 PwP across all stages of the disease. Participants will be allocated to either standard therapy plus 12 weekly sessions of ballet-based dancing followed by 'Tea and Biscuit' session or standard therapy with 'Tea and Biscuit' session on a 2:1 ratio. Non-motor symptoms, motor symptoms and quality of life will be measured using validated scales, questionnaires and wearable sensor recordings (Parkinson's KinetiGraph, GaitSmart). Furthermore, electrophysiological measures will be performed to determine the effects on cortical activity in a subgroup of participants. Assessments will be performed by a blinded rater at baseline and at the end of the intervention. The project will also explore the possibility of implementation of such therapy into the current pathways.

Due to COVID-19 pandemic, the delivery of the sessions will be a hybrid model - virtual sessions will be the primary method, with some capacity for in-person delivery when possible and deemed safe.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Effectiveness investigation eligibility criteria (PwPs only)

1. Inclusion:

• Age of 18 and upwards

• diagnosis of idiopathic Parkinson's disease (PD) according to the UK PD Brain Bank criteria

• Hoehn Yarhr stages I-V

2. Exclusion:

• diagnosis or suspicion of other causes for parkinsonism

• advanced-stage therapy consideration (deep brain stimulation, continuous levodopa duodenal infusion, and continuous subcutaneous apomorphine infusion)

• any condition interfering with the ability to give the informed consent

• Indication of dementia through a score of =21 on MoCA

• enrolment in a simultaneous investigational trial

• inability to travel to the weekly sessions

Implementation science investigation eligibility criteria f) Inclusion:

• People with Parkinson's - patients with a formal diagnosis of PD who have participated in the PD-Ballet intervention.

• Family members of PwP - relatives/carers/nominated person of the patients with a formal diagnosis of PD who have participated in the PD-Ballet intervention

• Clinicians (Referrers) - neurologists/geriatricians/neuropsychiatrists/SALT/OT, as well as PD specialist nurses, physicians and research staff experienced in PD

• Dance leaders (Deliverers) - English National Ballet dancers involved in the PD-Ballet project

• Support staff (Supporters)- other parties involved with the PD-Ballet project

g) Exclusion:

• People with Parkinson's - parkinsonism other than PD, lack of involvement in the PD-Ballet project

• Clinicians - Neurologists/geriatricians/neuropsychiatrists/SALT/OT, as well as PD specialist nurses, physicians and research staff experienced in PD

• Dance leaders - English National Ballet dancers not involved in the PD-Ballet project

• Support staff - other parties not involved with the PD-Ballet project

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Dance with ballet elements
Ballet-based dance sessions will be delivered by trained artists within the English National Ballet group in a professional dance space/ delivered remotely, COVID-19 permitting.

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust	King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total score of the Movement Disorders Society Sponsored Non-Motor Rating Scale	Clinical Effectiveness Primary Outcome Measure, higher score indicate worse non-motor symptomatology, the maximum score is 1008.	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Primary	Acceptability of Intervention Measure	Implementation Effectiveness Primary Outcome Measure - a 4 item, 5-point likert scale	post intervention (week 12)
Secondary	Change in total score of the Unified Parkinson's Disease Rating Scale	Clinical Effectiveness. A higher score indicates worse motor condition	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Change in total score of 10-meter walk test	Clinical Effectiveness. Time taken to walk 10 meters is calculated and compared at specific timepoints.	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Change in total score of King's Parkinson's Pain Scale	Clinical Effectiveness. A higher score indicates worse levels of pain	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Change in total score of Timed Up and Go test	Clinical Effectiveness. Time taken to carry out the test measured. A change between timepoints will be measured.	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Change in total score of Montreal Cognitive Assessment	Clinical Effectiveness. Maximum score 30. Lower scores indicate cognitive impairment.	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Clinical Impression of Severity Index for Parkinson's disease	provides a clinical judgment on Parkinson's disease (PD) severity based on motor symptoms and complications, cognitive status, and disability	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Change in total score of Parkinson's Disease Sleep Scale 2	Clinical Effectiveness. Higher score indicates worse sleep quality	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Change in total score of Parkinson's Disease Questionnaire-8	Clinical Effectiveness. A higher score indicates worse quality of life.	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Change in total score and sub-scores of Hospital Anxiety and Depression Scale	Clinical Effectiveness. Higher score indicates worse anxiety and depression.	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Change in total score of Schwab and England Scale	Clinical Effectiveness. A higher score indicates higher level of independence in performing activities of daily living.	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Change in total score of EQ-5D-5L questionnaire	Clinical Effectiveness. A lower score indicates better quality of life	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Change in total score of Parkinson's Fatigue Scale-16	Clinical Effectiveness. A higher score indicates more fatigue.	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Change in total score of Physical Activity Scale for the Elderly	Clinical Effectiveness. A higher score indicates more activity	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Change in total score of Starkstein Apathy Scale	Clinical Effectiveness. Higher score indicates more apathy.	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Change in total score of Wearing Off Questionnaire-9	Clinical Effectiveness. Higher score indicates worse wearing-off.	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Change in total score of Zaritt Burden Interview	Clinical Effectiveness. A higher score indicates more carer burden.	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Electrodiagnostic Measures - Transcranial Magnetic Stimulation paired with Electroencephalography and electromyography.	Clinical Effectiveness - exploratory measure. EMG data are analysed via Spike2 software (Cambridge Electronic Design). Peak-to-peak MEP amplitudes are measured for each trial and averaged per condition. SICI is calculated as the ratio of mean conditioned MEP to mean unconditioned MEP. TMS-evoked EEG potentials will be calculated by averaging artifact-free EEG trials for each experimental condition (i.e., before and after intervention). To smooth the signal a low-pass filter of 45 Hz will be applied to TEPs. The aim is to evaluate drug-induced changes for the 5 typical TEPs components (P = Positive, N = Negative) in accordance with the literature: N15-P25, N45, P70, N100, and P180.	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Change in the scores of Parkinson's KinetiGraph parameters (bradykinesia, dyskinesia, tremor, immobility)	Clinical Effectiveness, objective artigraphy based wearable sensor worn at home for 6 days at each time point.	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Feasibility of Intervention Measure (FIM)	Implementation Effectiveness - a 4-item, 5-point likert scale	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Intervention Appropriateness Measure (IAM)	Implementation Effectiveness - a 4-item, 5-point likert scale	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Sustainability scale (NOMAD)	Implementation Effectiveness - a 19 item implementation science survey (Finch et al., 2015)	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Secondary	Implementation costs	Health Economics - questionnaire regarding the potentially incurred costs related to clinical care for a person with Parkinson. The investigators will measure the potential change in direct and indirect costs incurred from clinical care.	Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability