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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Dance Program
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.
Other: Walking Program
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Rio Grande do Sul

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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