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Набор по приглашению NCT07278297

Parkinson Ballroom Fitness: The Impact of Personalized Dance on Motor- and Nonmotor Symptoms in People With Parkinson's

Без фазы С лечением Parkinson Disease (PD) Exercise Training Dance Therapy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: PB-Fit intervention.
Кому может быть актуально
Состояния в реестре: Parkinson Disease (PD), Exercise Training, Dance Therapy. Базовые параметры: от 40 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
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Обзор

Parkinson Ballroom-Fitness (PB-Fit) is a group-based dance program developed for people with Parkinson's disease. Through music and movement at three different levels (seated, standing, and walking), participants work on balance, gait, strength, and coordination, while also experiencing joy, social connection, and renewed vitality. The purpose of the present research project is to investigate whether seven weeks of PB-Fit training can improve gait and balance and enhance well-being and quality of life, and whether any effects are maintained twelve weeks after the intervention ends. The study is a randomized controlled trial with approximately forty participants and is conducted in collaboration with the Danish Parkinson's Association. The PB-Fit program is based on dance styles such as waltz, swing, and Latin, and is individually adapted. Training takes place in small groups, where participants learn basic steps and work with both motor and cognitive challenges. The program is evidence-informed but lacks quantitative evaluation, which is the aim of this study. PB-Fit is more than training-it is a community rooted in music, smiles, and meaningful relationships, where people with Parkinson's disease, regardless of functional level, are given the opportunity to experience joy, strength, and hope. This was clearly illustrated in the TV2 documentary "As Long as We Dance," in which several participants on the trip to Mallorca described their enthusiasm and the meaningfulness of PB-Fit. The study is led by Associate Professor Martin Langeskov Christensen, PhD (Regional Hospital Viborg), in collaboration with Aarhus University and dance instructor Elisabeth Dalsgaard. The results will be published in an international scientific journal and shared with both professionals and participants.

Подробное описание

Protocol Version 2, 23.04.2025

Parkinson Ballroom Fitness: The impact of personalized dance on motor- and nonmotor symptoms in people with Parkinson's

Members of the study group:

Principal Investigator:

Martin Langeskov Christensen, Associate Professor, PhD, Dept. of Clinical Medicine, Aarhus University and Researcher at Dept. of Neurology, Viborg Regional Hospital.

Co-investigators:

Theo S. Christensen, Scientific Assistant, MSc, Neurology, Viborg Regional Hospital.

Lars G. Hvid, Associate Professor, PhD, Aarhus University and Senior Researcher at The Danish MS Hospitals in Ry and Haslev.

Elisabeth Dalsgaard, Dance instructor and exercise physiologist, Owner of Swingtime Aps.

Background

Parkinson's disease (PD) is a chronic neurodegenerative disorder of the central nervous system characterized by the progressive loss of dopaminergic neurons in the substantia nigra. This loss leads to the cardinal motor symptoms of PD, including bradykinesia, rigidity, tremor, and postural instability . These motor symptoms significantly impair balance and walking capacity in individuals with PD, contributing to decreased quality of life and increased risk of falls .1 Moreover, problems with walking, balance and falls become increasingly important to people with PD as the condition progresses.2

Walking capacity in people with PD can be assessed through various tests, including the six spot step test (SSST) that involves challenging components of coordination and dynamic balance3, the Timed Up and Go (TUG) test as a measure of functional mobility, and falls risk prediction4, as well as 'fast' and 'endurance' walk tests such as the 10-meter walk test (10MWT)5 and the 6-minute walk test (6MWT)6, respectively . Balance impairments can be comprehensively assessed using tools such as the mini Balance Evaluation Systems Test (mini-BESTest), which evaluates dynamic balance, functional mobility, and gait .7-9 Additionally, The (modified) Four Square Step Test (mFSST10 / FSST11) can evaluate dynamic standing balance while stepping in multiple directions, and can be completed while requiring little equipment, space, and time in multiple rehabilitation settings. Furthermore, patient-reported outcomes such as the Parkinson's Disease Questionnaire (PDQ-39) can provide insights into the impact of PD on daily life and well-being12-14, whereas the Generic walking scale (Walk-12G)15,16 assesses the patient-reported impact of PD on different aspects of walking ability.

Exercise interventions, including those involving dance, have been shown effective in improving motor function and quality of life in people with PD.17 Interestingly, dance-based exercise appears particularly potent in terms of targeting impairments in balance, gait, and coordination through rhythmic and repetitive movements, offering both physical and cognitive benefits .18,19 However, more research is needed to determine its effects on non-motor symptoms and quality of life (QOL).19,20 Moreover, many dance modalities exist and ballroom dancing has received very little attention in this context21,22 with no evidence regarding the effectiveness of personalized dance interventions tailored to the functional levels and needs of individuals with PD.

Dance instructor and exercise physiologist Elisabeth Dalsgaard has developed a dance-based concept entitled Parkinson Ballroom Fitness (PB-Fit), specifically adapted for individuals with PD. This program focuses on the joy of movement and inclusion, with three difficulty levels corresponding to different overall disability categories (sitting, standing, and walking). Of note, the Danish Parkinson's Association previously received support to implement the project "Dance with Parkinsons". In the period 2017 to 2019, this project enabled the training of PB-Fit dance instructors and contributed to facilitating dance lessons for people with PD and their relatives all over Denmark. Yet this dance-based concept still awaits scientific evaluation in relation to motor and non-motor symptoms and QoL.

Study aims

Consequently, the main purpose of this study is to examine whether 7 weeks of PB-Fit (group-based personalized dance program) can improve walking capacity (primary outcome: SSST) and balance, alongside mental well-being and QoL in individuals with PD. An additional purpose is to evaluate these outcomes after 12 weeks of follow-up to determine the maintenance of potential dance-induced improvements and any behavioral changes. Of note, patients sitting in a wheelchair will also be included, but data from these participants will be analyzed separately in a secondary analysis.

Study hypothesis

We hypothesize that:

7 weeks of PB-Fit will elicit substantial improvements in walking capacity (particularly as measured by the SSST) and balance.

These improvements will be associated with enhancements in well-being and quality of life.

These improvements can be partly maintained after 12 weeks of follow-up, mainly due to behavioral changes such as participants continuing to dance.

Methods

Study design and inclusion criteria

A 7-week single-blinded, randomized controlled trial (RCT) will be conducted (Figure 1). Participants with PD will be recruited through social media platforms and local branches of the Danish Parkinson's Association. Clusters of participants (n=8-15) will be randomized to either the PB-Fit group or a waitlist control group when an adequate number has been identified and enrolled at one local branch/site. Baseline testing will precede randomization, and both groups will be re-evaluated post-interventions and the initial PB-Fit group again after a 12-week follow-up period.

The waitlist control group will continue their habitual lifestyle during the 7-week intervention period yet receive the same PB-Fit intervention afterwards.

Inclusion criteria:

Age ≥ 40 years

Clinical PD diagnosis

Ability to attend testing and dancing classes independently or with a caregiver / family

Exclusion criteria:

Comorbidities that prevent participation in the intervention

Moderate to severe cognitive impairment (Montreal Cognitive Assessment Test (MoCA) \<18)

Recent fractures or critical physical impairments

Participation in structured exercise therapy (including dancing) in the past 3 months (≥ 2 sessions per week of moderate-to-high intensity)

The study will be carried out following the regulations of the local scientific ethics committee and the Helsinki Declaration. All subjects will be informed about the purpose and the benefits/risks related to the study and have to provide written informed consent to participate.

PB-Fit Intervention

The intervention consists of 7 weeks of group-based PB-Fit sessions (2 per week). Group sizes will be approx. n=8-15 participants. The program, specifically adapted to PD, includes various dances (e.g., Latin, Waltz, Swing, HipHop) with different tempos to accommodate varying abilities. The concept is based on learning basic steps across the different dances, irrespective of disability level (sitting, standing, walking). Different tempos are presented, thereby enabling the participants to choose the rhythm according to their own starting point. Whilst the dances may differ in terms of taxing different bodily/physiological/functional aspects, these are the main aspects that are being targeted:

Balance: Each dance step is a weight transfer - and thus balance training.

Muscle strength: Involvement of both the lower and upper body hold aspects of muscle strength training.

Coordination: Steps and arms must be coordinated both in single steps and in small series.

Вмешательства

  • Другое PB-Fit intervention
    The intervention is 7 weeks of Parkinson Ballroom Fitness. A dance exercise program made specifically for persons with Parkinson Disease. This the first study to assess the effects of Parkinson Ballroom Fitness on motor and non-motor symptoms in persons with Parkinson Disease.

Первичные конечные точки

  • Six Spot Step Test (SSST) [Срок оценки: 7 weeks (from baseline assessment to post assessment)]

Критерии участия

Критерии включения

  • Age ≥ 40 years
  • Clinical PD diagnosis
  • Ability to attend testing and dancing classes independently or with a caregiver / family

Критерии исключения

  • Comorbidities that prevent participation in the intervention
  • Moderate to severe cognitive impairment (Montreal Cognitive Assessment Test (MoCA) <18)
  • Recent fractures or critical physical impairments
  • Participation in structured exercise therapy (including dancing) in the past 3 months (≥ 2 sessions per week of moderate-to-high intensity)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Дания · 1 центр
  • Viborg Regional Hospital — Viborg

Идентификаторы

NCT: NCT07278297 · 1-10-72-46-25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗