- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03370315
Effects of a Dance and Walking Program for People With Parkinson's Disease (DANCEPD)
December 26, 2017 updated by: Aline Nogueira Haas, Federal University of Rio Grande do Sul
Effects of a Dance and Walking Program on Gait and Quality of Life in People With Parkinson's Disease
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil
- Universidade Federal do Rio Grande do Sul
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dance Group
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. |
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.
|
|
Experimental: Walking Group
This group will be undergo walking training two times a week, for 12 weeks. 24 sessions. Intervention administered: Walking program with 3 different moments. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change in functional mobility
Time Frame: Before and after 12 weeks after the intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change in the gait specific parameters
Time Frame: Before and after 12 weeks after the intervention
|
The gait specific parameters will be assessed using the BTS SMART DX 7000.
This secondary 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
|
|
The change in Quality of Life
Time Frame: Before and after 12 weeks after the intervention
|
Quality of Life will be assessed using Parkinsons' Disease Questionnaire (PDQ-39).
The Quality of Life questionnaire will be evaluated before and after 12 weeks of Dance Classes and Walking Training in both groups.
Parkinson's Disease Questionnaire (PDQ39) measures patients' quality of life through 39 questions.
The instrument is divided into eight dimensions: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort.
In total, patients answer 39 questions that should be noted among five response options: "never," "rarely," "sometimes," "often" or "always."
|
Before and after 12 weeks after the intervention
|
|
The change in motor symptoms
Time Frame: Before and after 12 weeks after the intervention
|
Motor symptoms will be assessed using Unified Parkinsons' Disease Rating Scale (UPDRS).
The motor symptoms will be evaluated before and after 12 weeks of Dance Classes and Walking Training in both groups.
We will use the Part III of the Unified Parkinson's Disease Rating Scale (UPDRS III), which measures the motor symptoms of the disease.
Part III of the UPDRS is composed of 14 items, covering questions 18 to 31 of the scale.
Each item has 5 response options that add up to 0 to 4 points, how bigger is the total score on the scale; greater is the patient's motor impairment.
|
Before and after 12 weeks after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Aline N. Haas, PhD, Federal University of Rio Grande do Sul
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
December 5, 2017
Study Registration Dates
First Submitted
December 7, 2017
First Submitted That Met QC Criteria
December 7, 2017
First Posted (Actual)
December 12, 2017
Study Record Updates
Last Update Posted (Actual)
December 28, 2017
Last Update Submitted That Met QC Criteria
December 26, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DANPD017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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