NCT03370315

Brief Summary

Parkinson's disease (PD), characterized as progressive and neurodegenerative, is one of the most frequent neurological diseases of the present time. Patients with PD present motor impairment, such as muscle stiffness, rest tremor, slow movements, postural instability, and gait and balance alterations; And non-motor factors, such as cognitive and neuropsychiatric disorders, depressive symptoms, and a consequent decrease in quality of life (QL). Dance can be an important tool for the complementary treatment of these patients, when added to traditional drug therapies and physiotherapies. Thus, the present study aims to verify the effects of a program of dance and walking in gait and QL of 38 adults with PD, divided in two groups, and to compare the aspects of functionality, dynamic stability, kinematics and QL. The data collection instruments will be a personal data sheet of the patients, the Hoehn and Yahr Scale (H\&Y), the Rehabilitation Index (RI), the motor part of the Unified PD Rating Scale (UPDRS III), the Timed Up ang Go test (TUG), the kinematic analysis of walking and the Parkinson's Disease Questionnaire (PDQ-39). Statistical Package for Social Sciences (SPSS) software version 20.0 will be used to analyze the data, using the Wilcoxon test for non-parametric data and the paired t-test for parametric data, in order to compare pre and post intervention data. The significance level adopted for both tests will be p \<0.05. It is expected that a program of 24 sessions of dance classes will be as or more effective than a program of 24 walking sessions for the gait quality and QL for the participants of the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
Last Updated

December 28, 2017

Status Verified

December 1, 2017

Enrollment Period

Same day

First QC Date

December 7, 2017

Last Update Submit

December 26, 2017

Conditions

Keywords

Parkinsonian DisordersDance TherapyRehabilitationKinematicsLocomotionQuality of Life

Outcome Measures

Primary Outcomes (1)

  • The change in functional mobility

    The functional mobility will be assessed using the Timed Up and Go Test. This first outcome will be evaluated before and after 12 weeks of Dance Classes and Walking Training in both groups.

    Before and after 12 weeks after the intervention

Secondary Outcomes (3)

  • The change in the gait specific parameters

    Before and after 12 weeks after the intervention

  • The change in Quality of Life

    Before and after 12 weeks after the intervention

  • The change in motor symptoms

    Before and after 12 weeks after the intervention

Study Arms (2)

Dance Group

EXPERIMENTAL

This group will be undergo dance classes two times a week, for 12 weeks. 24 sessions. Intervention administered: Dance classes inspired by the rhythm of Forró and Samba.

Other: Dance Program

Walking Group

EXPERIMENTAL

This group will be undergo walking training two times a week, for 12 weeks. 24 sessions. Intervention administered: Walking program with 3 different moments.

Other: Walking Program

Interventions

The dance program consists of dance classes inspired by the rhythm of Forró and Samba. The sessions are divided into four stages: 1) stretching and sensitization of the body, with the support of chairs; 2) balance and rhythm exercises, with the support of the bar; 3) dance inspired by the genres worked - Forró and Samba; 4) Fun activities that stimulate socialization or with visual clues, working displacements, motor coordination, rhythm, improvisation and creativity. 24 sessions, twice a week, which session take 60 min.

Dance Group

The walking program consists of 3 moments: 1) a brief warm-up of free walking for 3 minutes in the comfortable velocity; 2) then walking according to the training cycle, the intensity will be between 60 and 80% of the reserve heart rate; 3) a relaxation. 24 sessions, twice a week, which session take 60 min.

Walking Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both sex;
  • Equal to or more than 50 years old;
  • Parkinson Disease in regular medical treatment and follow-up;
  • Illness diagnosis equal to or more than one year;
  • H\&Y scale between one and three;
  • Able to walk independently or with a walking stick.

You may not qualify if:

  • More than six absences in dance class or in the walking training (25%);
  • Start a new activity parallel to the project;
  • Risk factors: Recent surgeries, Deep brain stimulation surgery (DBS), Other associated neurological diseases or other chronic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (4)

  • Hackney ME, Kantorovich S, Levin R, Earhart GM. Effects of tango on functional mobility in Parkinson's disease: a preliminary study. J Neurol Phys Ther. 2007 Dec;31(4):173-9. doi: 10.1097/NPT.0b013e31815ce78b.

  • Cavagna GA, Franzetti P, Heglund NC, Willems P. The determinants of the step frequency in running, trotting and hopping in man and other vertebrates. J Physiol. 1988 May;399:81-92. doi: 10.1113/jphysiol.1988.sp017069.

  • Shanahan J, Morris ME, Bhriain ON, Saunders J, Clifford AM. Dance for people with Parkinson disease: what is the evidence telling us? Arch Phys Med Rehabil. 2015 Jan;96(1):141-53. doi: 10.1016/j.apmr.2014.08.017. Epub 2014 Sep 16.

  • Dos Santos Delabary M, Monteiro EP, Donida RG, Wolffenbuttel M, Peyre-Tartaruga LA, Haas AN. Can Samba and Forro Brazilian rhythmic dance be more effective than walking in improving functional mobility and spatiotemporal gait parameters in patients with Parkinson's disease? BMC Neurol. 2020 Aug 18;20(1):305. doi: 10.1186/s12883-020-01878-y.

MeSH Terms

Conditions

Parkinson DiseaseParkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Aline N. Haas, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 12, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2017

Study Completion

December 5, 2017

Last Updated

December 28, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations