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

NCT04719468 | Unknown

• 1 other identifier: 275588
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

dance; ballet; complementary therapy; exercise; multimodal

Outcome Measures

Primary Outcomes (2)

• 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

• Acceptability of Intervention Measure

  Implementation Effectiveness Primary Outcome Measure - a 4 item, 5-point likert scale

  post intervention (week 12)

Secondary Outcomes (22)

• Change in total score of the Unified Parkinson's Disease Rating Scale

  Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability

• Change in total score of 10-meter walk test

  Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability

• Change in total score of King's Parkinson's Pain Scale

  Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability

• Change in total score of Timed Up and Go test

  Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability

• Change in total score of Montreal Cognitive Assessment

  Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability

Study Arms (2)

Intervention

EXPERIMENTAL

Other: Dance with ballet elements

Usual Treatment

NO INTERVENTION

usual treatment with the addition of joining 'Tea and Biscuit' sessions remotely

Interventions

Dance with ballet elements OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• King's College London: collaborator

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

Related Publications (2)

• Podlewska AM, Batzu L, Soukup T, Sevdalis N, Bakolis I, Derbyshire-Fox F, Hartley A, Healey A, Woods A, Crane N, Pariante C, Ray Chaudhuri K. The PD-Ballet study: study protocol for a randomised controlled single-blind hybrid type 2 clinical trial evaluating the effects of ballet dancing on motor and non-motor symptoms in Parkinson's disease. BMC Complement Med Ther. 2024 Jan 17;24(1):41. doi: 10.1186/s12906-023-04296-y.

  PMID: 38233784 DERIVED

• 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.

  PMID: 35105591 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Officials

• K Ray Chaudhuri, Professor

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandra Podlewska, MSc

CONTACT

02032997189; aleksandra.podlewska@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded rater
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: January 22, 2021
• Study Start: February 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)