Parkinson DiseaseDANCEPDNCT03370315
Effects of a Dance and Walking Program for People With Parkinson's Disease
A study testing Dance Program and Walking Program in people with Parkinson Disease, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Dance Program and Walking Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2017to 5 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Being tested
- Dance Program, Walking Program
- Keywords
- Parkinsonian Disorders, Dance Therapy, Rehabilitation, Kinematics, Locomotion, Quality of Life
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance ProgramOther
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.
Walking ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Walking Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after 12 weeks after the intervention
Secondary outcomes (3)
The change in the gait specific parameters
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.
Measured: Before and after 12 weeks after the intervention
The change in Quality of Life
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."
Measured: Before and after 12 weeks after the intervention
The change in motor symptoms
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.
Measured: Before and after 12 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start1 Jul 2017
- Primary completion1 Jul 2017
- Study completion5 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aline Nogueira Haas, Federal University of Rio Grande do Sul
- Investigators
- Aline N. Haas, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370315
- Sponsor's protocol ID
- DANPD017
- Acronym
- DANCEPD
- Status last verified
- Dec 2017
- First submitted
- 7 Dec 2017
- Last updated
- 28 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 18172414Cavagna 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.
PubMed 3404473Shanahan 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.
PubMed 25223491Dos 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.
PubMed 32811464
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Dance and Walking Program on Gait and Quality of Life in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03370315
- Acronym / sponsor ID
- DANCEPD / DANPD017
- Conditions
- Parkinson Disease
- Keywords
- Parkinsonian Disorders, Dance Therapy, Rehabilitation, Kinematics, Locomotion, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 5 Dec 2017 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dance Group | Experimental | Other: Dance ProgramThis 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. |
| Walking Group | Experimental | Other: Walking ProgramThis group will be undergo walking training two times a week, for 12 weeks. 24 sessions. Intervention administered: Walking program with 3 different moments. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance ProgramThe 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. | Other | Dance Group |
| Walking ProgramThe 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. | Other | Walking Group |
Primary outcome
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.
3 secondary outcomes
The change in the gait specific parameters
Time frame: Before and after 12 weeks after the intervention
The change in Quality of Life
Time frame: Before and after 12 weeks after the intervention
The change in motor symptoms
Time frame: Before and after 12 weeks after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Results publication: PubMed 18172414Hackney 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.
- Results publication: PubMed 3404473Cavagna 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.
- Results publication: PubMed 25223491Shanahan 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.
- Derived from this study: PubMed 32811464Dos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aline N. Haas, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance Program and Walking Program in people with Parkinson Disease, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in functional mobility (time frame: Before and after 12 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03370315, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2017; AzTrials last refreshed its copy on 1 Nov 2026.