TY - JOUR
T1 - The PD-Ballet study
T2 - 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
AU - Podlewska, Aleksandra M.
AU - Batzu, Lucia
AU - Soukup, Tayana
AU - Sevdalis, Nick
AU - Bakolis, Ioannis
AU - Derbyshire-Fox, Fleur
AU - Hartley, Alison
AU - Healey, Andy
AU - Woods, Anthony
AU - Crane, Nikki
AU - Pariante, Carmine
AU - Ray Chaudhuri, K.
N1 - Funding Information:
This programme is funded by the Wellcome Trust SHAPER Programme (award reference 219425/Z/19/Z) and covers the design of the study and collection, analysis, and interpretation of the data. This work is additionally supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London and by a NIHR Investigator, to CP.
Funding Information:
We thank all the participants and researchers working on this study. We also thank Maria Lucia Mz Urbe, and all the ENB volunteers, as well as the CRISP Expert Patient Group at King’s College Hospital. Special thanks go to Juliet Staunton, Phoebe Tall and Aleksandra Lukawska for their efforts.
Funding Information:
IB’s research is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) South London at King’s College Hospital NHS Foundation Trust. IB, is supported by the NIHR Maudsley Biomedical Research Centre. The views expressed in this publication are those of the authors and not necessarily those of the charities, the NIHR, the NHS or the Department of Health and Social Care. Infrastructure support for this research for TS was provided by NIHR London Medtech and In vitro diagnostic Co-operative.
Publisher Copyright:
© 2023, The Author(s).
PY - 2024/1/17
Y1 - 2024/1/17
N2 - Background: To date, beneficial effects of multimodal exercise programmes on Parkinson’s disease (PD) have focused on motor symptoms and little attention has been paid to the potential effects of such programmes on the non-motor symptoms of PD, which are now universally known as one of the key drivers of quality of life and a key unmet need. We aim to explore clinical effectiveness of a ballet-based dance programme in addressing non-motor and motor symptoms of Parkinson’s disease across all stages of progression. Methods: A randomised, single-blind, controlled trial of 160 people with Parkinson’s across all motor stages (Participants will be stratified into three groups of motor advancement: Hoehn and Yahr (HY) stages I and II being Mild Group, HY Stage III being Moderate Group and HY Stages IV and V being Severe Group) will be randomly allocated to either an intervention or a control group using an independent randomisation body. The primary outcome is an improvement in non-motor symptoms as measured by the Movement Disorders Society Non-Motor Scale (MDS-NMS). The intervention protocol consists of 12 one-weekly dance sessions led by English National Ballet. Each session is followed by a ‘tea and biscuit’ social time. Control group follows standard clinical pathway and joins the ‘tea and biscuit’ to control for any positive effects of social interactions. All participants are assessed at baseline, immediately after completion of the intervention and 3–6 months later to explore any potential longitudinal effects. Discussion: To our knowledge, no adequately powered study has explored the effects of a dance-based intervention on non-motor symptoms of Parkinson’s disease, assessing these on both holistic and granular levels. We also aim to stratify participants in accordance with their motor state as assessed by. HY staging to explore specific effects on the symptoms at the initial, moderate and complex stages of the disease. If successful, this trial provides first evidence on clinical effectiveness of a ballet-based dance intervention for symptoms of Parkinson’s disease, assessed in a robust, rigorous manner. Trial registration: NCT04719468.
AB - Background: To date, beneficial effects of multimodal exercise programmes on Parkinson’s disease (PD) have focused on motor symptoms and little attention has been paid to the potential effects of such programmes on the non-motor symptoms of PD, which are now universally known as one of the key drivers of quality of life and a key unmet need. We aim to explore clinical effectiveness of a ballet-based dance programme in addressing non-motor and motor symptoms of Parkinson’s disease across all stages of progression. Methods: A randomised, single-blind, controlled trial of 160 people with Parkinson’s across all motor stages (Participants will be stratified into three groups of motor advancement: Hoehn and Yahr (HY) stages I and II being Mild Group, HY Stage III being Moderate Group and HY Stages IV and V being Severe Group) will be randomly allocated to either an intervention or a control group using an independent randomisation body. The primary outcome is an improvement in non-motor symptoms as measured by the Movement Disorders Society Non-Motor Scale (MDS-NMS). The intervention protocol consists of 12 one-weekly dance sessions led by English National Ballet. Each session is followed by a ‘tea and biscuit’ social time. Control group follows standard clinical pathway and joins the ‘tea and biscuit’ to control for any positive effects of social interactions. All participants are assessed at baseline, immediately after completion of the intervention and 3–6 months later to explore any potential longitudinal effects. Discussion: To our knowledge, no adequately powered study has explored the effects of a dance-based intervention on non-motor symptoms of Parkinson’s disease, assessing these on both holistic and granular levels. We also aim to stratify participants in accordance with their motor state as assessed by. HY staging to explore specific effects on the symptoms at the initial, moderate and complex stages of the disease. If successful, this trial provides first evidence on clinical effectiveness of a ballet-based dance intervention for symptoms of Parkinson’s disease, assessed in a robust, rigorous manner. Trial registration: NCT04719468.
KW - Dance
KW - Exercise
KW - Intervention
KW - Non-motor symptoms
KW - Parkinson’s disease
KW - Programmed exercise
KW - RCT
UR - http://www.scopus.com/inward/record.url?scp=85182426893&partnerID=8YFLogxK
U2 - 10.1186/s12906-023-04296-y
DO - 10.1186/s12906-023-04296-y
M3 - Article
C2 - 38233784
AN - SCOPUS:85182426893
SN - 2662-7671
VL - 24
JO - BMC Complementary Medicine and Therapies
JF - BMC Complementary Medicine and Therapies
IS - 1
M1 - 41
ER -