Clinical trial NCT04719468: PD-Ballet: Effectiveness and Implementation in Parkinson's Disease
Official title: Efficacy of Ballet Dancing on Motor and Non-motor Symptoms of Parkinson's Disease: a Hybrid Type 2 Effectiveness-implementation Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: dance
ballet
complementary therapy
exercise
multimodal
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2021-01-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in total score of the Movement Disorders Society Sponsored Non-Motor Rating Scale
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Acceptability of Intervention Measure
timeFrame: post intervention (week 12)
Secondary outcomes:
measure: Change in total score of the Unified Parkinson's Disease Rating Scale
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Change in total score of 10-meter walk test
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Change in total score of King's Parkinson's Pain Scale
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Change in total score of Timed Up and Go test
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Change in total score of Montreal Cognitive Assessment
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Clinical Impression of Severity Index for Parkinson's disease
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Change in total score of Parkinson's Disease Sleep Scale 2
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Change in total score of Parkinson's Disease Questionnaire-8
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Change in total score and sub-scores of Hospital Anxiety and Depression Scale
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Change in total score of Schwab and England Scale
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Change in total score of EQ-5D-5L questionnaire
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Change in total score of Parkinson's Fatigue Scale-16
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Change in total score of Physical Activity Scale for the Elderly
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Change in total score of Starkstein Apathy Scale
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Change in total score of Wearing Off Questionnaire-9
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Change in total score of Zaritt Burden Interview
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Electrodiagnostic Measures - Transcranial Magnetic Stimulation paired with Electroencephalography and electromyography.
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Change in the scores of Parkinson's KinetiGraph parameters (bradykinesia, dyskinesia, tremor, immobility)
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Sustainability scale (NOMAD)
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
measure: Implementation costs
timeFrame: Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
affiliation: King's College London
name: K Ray Chaudhuri, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soukup T, Davis RE, Baldellou Lopez M, Healey A, Estevao C, Fancourt D, Dazzan P, Pariante C, Dye H, Osborn T, Bind R, Sawyer K, Rebecchini L, Hazelgrove K, Burton A, Manoharan M, Perkins R, Podlewska A, Chaudhuri R, Derbyshire-Fox F, Hartley A, Woods A, Crane N, Bakolis I, Sevdalis N. Study protocol: randomised controlled hybrid type 2 trial evaluating the scale-up of two arts interventions for postnatal depression and Parkinson's disease. BMJ Open. 2022 Feb 1;12(2):e055691. doi: 10.1136/bmjopen-2021-055691.