NCT04422353

Brief Summary

The aim of this study is to analyze the impact of video dance class and unsupervised physical activity on clinical-functional parameters, self-isolation and non-motors symptoms in people with Parkinson's disease during the Covid-19 pandemic.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

June 7, 2020

Last Update Submit

May 11, 2021

Conditions

Keywords

Functionalitymovement disordersrehabilitationdepressive symptomsquality of lifecognitionself-isolation

Outcome Measures

Primary Outcomes (3)

  • Quality of life (QoL)

    The quality of life (QoL) will be measured by the Parkinson's Disease Quality of life (PDQ-8). PDQ-8 is a reduced version of a specific health status questionnaire comprising 39 items, with 8 items. Respondents are requested to affirm one of five ordered response categories according to how often, due to their PD, they have experienced the problem defined by each item. Each item is grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100 (100¼more health problems).

    Change from baseline at 12 weeks.

  • Depressive symptoms - Geriatric Depression Scale - 15 item

    This outcome will be measure for the Geriatric Depression Scale - 15 item. The scale consists of 15 dichotomous questions in which participants are asked to answer yes or no about how they felt over the past week (for instance, "Do the patient feel that their life is empty?," Do the patient feel that their situation is hopeless?). Scores range from 0 to 15 with higher scores indicating more depressive symptoms.

    Change from baseline at 12 weeks.

  • Physical Activity - International Physical Activity Questionnaires (IPAQ)

    This outcome will be measure for the International Physical Activity Questionnaires (IPAQ). The IPAQ comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.

    Change from baseline at 12 weeks.

Secondary Outcomes (3)

  • Cognitive function - Montreal Cognitive Assessment by telephone

    Change from baseline at 12 weeks.

  • Falls - Falls Efficacy Scale - International

    Change from baseline at 12 weeks.

  • Functional lower extremity strength -Five Times Sit to Stand Test

    Change from baseline at 12 weeks.

Study Arms (3)

video Dance classes

EXPERIMENTAL

The dance program consists of dance lessons inspired by Forró rhythm and Samba rhythm. Classes will be divided into four stages: Joint warm-up and stretching on the chairs; strengthening, balance, and rhythm exercises with the support of the chair; exercises inspired by the samba and forró (Brazilian ballroom dance) basic steps; and Final cool down. The classes will be held through a recorded video that must be played twice a week. Each video class lasts 30 minutes. The video Dance classes will happen in the period of self-isolation and social distance during the Covid-19 pandemic.

Other: Video Dance classes

Unsupervised physical activities

ACTIVE COMPARATOR

The unsupervised physical activity programs will happen in the period of self-isolation and social distance during the Covid-19 pandemic. The classes will be held through a recorded video that must be played twice a week. Each video class lasts 30 minutes.

Other: Unsupervised physical activities

control group

NO INTERVENTION

The control group will be people with PD, engaged, before the Covid-19 pandemic, in the Dance, the Nordic Walk and the Aquatic Jogging extension projects at Federal University of Rio Grande do Sul but did not do any type of physical activity during the Covid-19 pandemic.

Interventions

The dance program consists of dance lessons inspired by Forró rhythm and Samba rhythm. The classes will be held through a recorded video that must be played twice a week. Each video class lasts 30 minutes.

video Dance classes

The classes will be held through a recorded video that must be played twice a week. Each video class lasts 30 minutes.

Unsupervised physical activities

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers
  • aged over 50 years
  • both sexes
  • clinical diagnosis of idiopathic PD
  • PD staging between 1 and 4 in Hoehn and Yahr Scale (H\&Y)
  • Peoples with PD engaged, before the Covid-19 pandemic, in the Dance, the Nordic Walk and the Aquatic Jogging extension projects at Federal University of Rio Grande do Sul.

You may not qualify if:

  • performing recent surgeries, deep brain stimulation (DBS - Deep Brain Stimulations);
  • severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year, being a pacemaker;
  • stroke or other associated neurological diseases; insanity;
  • prostheses in the lower limbs;
  • without ambulation conditions.

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, 90690-200, Brazil

RECRUITING

Related Publications (18)

  • Alberts JL, Linder SM, Penko AL, Lowe MJ, Phillips M. It is not about the bike, it is about the pedaling: forced exercise and Parkinson's disease. Exerc Sport Sci Rev. 2011 Oct;39(4):177-86. doi: 10.1097/JES.0b013e31822cc71a.

    PMID: 21799425BACKGROUND
  • Dereli EE, Yaliman A. Comparison of the effects of a physiotherapist-supervised exercise programme and a self-supervised exercise programme on quality of life in patients with Parkinson's disease. Clin Rehabil. 2010 Apr;24(4):352-62. doi: 10.1177/0269215509358933.

    PMID: 20360152BACKGROUND
  • Beato RG, Nitrini R, Formigoni AP, Caramelli P. Brazilian version of the Frontal Assessment Battery (FAB): Preliminary data on administration to healthy elderly. Dement Neuropsychol. 2007 Jan-Mar;1(1):59-65. doi: 10.1590/S1980-57642008DN10100010.

    PMID: 29213369BACKGROUND
  • Frazzitta G, Balbi P, Maestri R, Bertotti G, Boveri N, Pezzoli G. The beneficial role of intensive exercise on Parkinson disease progression. Am J Phys Med Rehabil. 2013 Jun;92(6):523-32. doi: 10.1097/PHM.0b013e31828cd254.

    PMID: 23552330BACKGROUND
  • 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.

    PMID: 18172414BACKGROUND
  • Herman T, Giladi N, Gruendlinger L, Hausdorff JM. Six weeks of intensive treadmill training improves gait and quality of life in patients with Parkinson's disease: a pilot study. Arch Phys Med Rehabil. 2007 Sep;88(9):1154-8. doi: 10.1016/j.apmr.2007.05.015.

    PMID: 17826461BACKGROUND
  • Hoehn MM, Yahr MD. Parkinsonism: onset, progression and mortality. Neurology. 1967 May;17(5):427-42. doi: 10.1212/wnl.17.5.427. No abstract available.

    PMID: 6067254BACKGROUND
  • Morris M, Iansek R, McGinley J, Matyas T, Huxham F. Three-dimensional gait biomechanics in Parkinson's disease: evidence for a centrally mediated amplitude regulation disorder. Mov Disord. 2005 Jan;20(1):40-50. doi: 10.1002/mds.20278.

    PMID: 15390033BACKGROUND
  • Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

    PMID: 1991946BACKGROUND
  • Reuter I, Mehnert S, Leone P, Kaps M, Oechsner M, Engelhardt M. Effects of a flexibility and relaxation programme, walking, and nordic walking on Parkinson's disease. J Aging Res. 2011;2011:232473. doi: 10.4061/2011/232473. Epub 2011 Mar 30.

    PMID: 21603199BACKGROUND
  • 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.

    PMID: 25223491BACKGROUND
  • Sharp K, Hewitt J. Dance as an intervention for people with Parkinson's disease: a systematic review and meta-analysis. Neurosci Biobehav Rev. 2014 Nov;47:445-56. doi: 10.1016/j.neubiorev.2014.09.009. Epub 2014 Sep 28.

    PMID: 25268548BACKGROUND
  • Tuon T, Valvassori SS, Dal Pont GC, Paganini CS, Pozzi BG, Luciano TF, Souza PS, Quevedo J, Souza CT, Pinho RA. Physical training prevents depressive symptoms and a decrease in brain-derived neurotrophic factor in Parkinson's disease. Brain Res Bull. 2014 Sep;108:106-12. doi: 10.1016/j.brainresbull.2014.09.006. Epub 2014 Sep 28.

    PMID: 25264157BACKGROUND
  • Zigmond MJ, Smeyne RJ. Exercise: is it a neuroprotective and if so, how does it work? Parkinsonism Relat Disord. 2014 Jan;20 Suppl 1:S123-7. doi: 10.1016/S1353-8020(13)70030-0.

    PMID: 24262162BACKGROUND
  • Helmich RC, Bloem BR. The Impact of the COVID-19 Pandemic on Parkinson's Disease: Hidden Sorrows and Emerging Opportunities. J Parkinsons Dis. 2020;10(2):351-354. doi: 10.3233/JPD-202038. No abstract available.

    PMID: 32250324BACKGROUND
  • Victorino DB, Guimaraes-Marques M, Nejm M, Scorza FA, Scorza CA. COVID-19 and Parkinson's Disease: Are We Dealing with Short-term Impacts or Something Worse? J Parkinsons Dis. 2020;10(3):899-902. doi: 10.3233/JPD-202073. No abstract available.

    PMID: 32390643BACKGROUND
  • Hong J, Kong HJ, Yoon HJ. Web-Based Telepresence Exercise Program for Community-Dwelling Elderly Women With a High Risk of Falling: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 May 28;6(5):e132. doi: 10.2196/mhealth.9563.

    PMID: 29807877BACKGROUND
  • Monteiro EP, Franzoni LT, Cubillos DM, de Oliveira Fagundes A, Carvalho AR, Oliveira HB, Pantoja PD, Schuch FB, Rieder CR, Martinez FG, Peyre-Tartaruga LA. Effects of Nordic walking training on functional parameters in Parkinson's disease: a randomized controlled clinical trial. Scand J Med Sci Sports. 2017 Mar;27(3):351-358. doi: 10.1111/sms.12652. Epub 2016 Feb 2.

MeSH Terms

Conditions

Parkinson DiseaseParkinson Disease 10Movement DisordersDepression

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSynucleinopathiesNeurodegenerative DiseasesBehavioral SymptomsBehavior

Study Officials

  • Leonardo A. Peyré-Tartaruga, PhD

    Federal University of Rio Grande do Sul

    STUDY DIRECTOR

Central Study Contacts

Leonardo A. Peyré-Tartaruga, PhD

CONTACT

Aline N. Haas, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

June 7, 2020

First Posted

June 9, 2020

Study Start

May 1, 2020

Primary Completion

June 30, 2021

Study Completion

December 30, 2024

Last Updated

May 14, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations