NCT03860649

Brief Summary

The aim of study is to analyze the effects of different physical therapies (Aquatic Jogging, Neurofunctional Physiotherapy, Pilates Training and Nordic Walking) and Dance and compare with unsupervised home exercises in the clinical-functional parameters, postural balance, muscular echographic quality, pendulum gait mechanism, and serum levels of BDNF in people with Parkinson's disease with camptocormia or Pisa Syndrome.

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
100

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Aug 2018

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

August 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

12 months

First QC Date

December 5, 2018

Last Update Submit

June 6, 2020

Conditions

Keywords

MobilityFunctionalityMovement disordersRehabilitationLocomotion

Outcome Measures

Primary Outcomes (1)

  • Test Timed Up and Go

    Test Timed Up and Go This teste evaluate the mobility functional in three meters of self-selected speed (TUGSS) or at forced speed (TUGFS).

    Change from baseline at 12 weeks.

Secondary Outcomes (7)

  • Locomotor Rehabilitation Index

    Change from baseline at 12 weeks.

  • Self-selected walking speed

    Change from baseline at 12 weeks.

  • Optimal Walking Speed (OPT)

    Change from baseline at 12 weeks.

  • Quality of life (QoL): PDQ-39

    Change from baseline at 12 weeks.

  • Cognitive function - Montreal Cognitive Assessment

    Change from baseline at 12 weeks.

  • +2 more secondary outcomes

Other Outcomes (22)

  • Motor symptoms

    Change from baseline at 12 weeks.

  • Freezing of Gait

    Change from baseline at 12 weeks.

  • Balance Static

    Change from baseline at 12 weeks.

  • +19 more other outcomes

Study Arms (4)

Nordic Walking

EXPERIMENTAL

The patient walk program consists of 3 moments: warm up, walk and stretch. They will do a brief free walking warm-up for 3 minutes in the Self-selected walking speed - SSWS (3 'SSWS), then walk according to the training cycle, the intensity will be between 60 to 80% of the Heart of Ratio reserve. In addition, the intensity of the classes will be measured in each phase by the Borg Scale of Perceived Exertion.

Other: Nordic Walking

Jogging

EXPERIMENTAL

This group will undergo 24 Dance sessions. Aquatic therapy patients will receive deep water running intervention with the use of flotation vests. The exercises will consist of: immersion, balance, strength, agility, and movement within the water. The intensity of the classes will be measured in each moment and by the Borg Scale of Perceived Exertion.

Other: Jogging

Dance

EXPERIMENTAL

This group will undergo 24 Dance sessions inspired by Forró dance rhythm and Samba dance 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 barre; exercises inspired by the Samba and Forró dance (Brazilian ballroom dance) basic steps; and Final cool down. The intensity of the classes will be measured according to the beats per minute (BPMs) of the songs used in each moment and by the Borg Scale of Perceived Exertion.

Other: Dance

Pilates Training

EXPERIMENTAL

Classes composed of three phases: Warming up, main part and back to calm. Warming up will begin with pre-Pilates training exercises for 5 minutes (eg. breathing exercises, hip joint mobilization, shoulder girdle, etc.), the main part of the lesson will be the Pilates training drill sequence for the beginner level that will be conducted for 50 minutes in which all exercises will be performed on the floor. The sequence of the eighteen exercises of the main part of the lesson is described in the table below. Back to Calm: will be carried out for 5 final minutes with standing exercises with the subject reclining on the wall to reconnect the subject with orthostatic posture. In the each of the phases of the lesson will be shown to the subject the table of BORG with the objective of measuring the intensity of perceived exertion, using the Borg Scale of Perceived Exertion.

Other: Pilates Training

Interventions

24 sessions will be held twice a week, with each session taking an average of 60 minutes.

Nordic Walking
JoggingOTHER

24 sessions will be held twice a week, with each session taking an average of 60 minutes.

Jogging
DanceOTHER

24 sessions will be held twice a week, with each session taking an average of 60 minutes.

Dance

24 sessions will be held twice a week, with each session taking an average of 60 minutes.

Pilates Training

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers
  • aged over 40 years
  • both sexes
  • clinical diagnosis of idiopathic PD
  • PD staging between 1 and 4 in Hoehn and Yahr Scale (H\&Y).

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)

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90690200, Brazil

Location

Related Publications (34)

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    PMID: 27017543BACKGROUND
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    PMID: 18172414BACKGROUND
  • Hausdorff JM, Schaafsma JD, Balash Y, Bartels AL, Gurevich T, Giladi N. Impaired regulation of stride variability in Parkinson's disease subjects with freezing of gait. Exp Brain Res. 2003 Mar;149(2):187-94. doi: 10.1007/s00221-002-1354-8. Epub 2003 Jan 22.

    PMID: 12610686BACKGROUND
  • 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
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    PMID: 6067254BACKGROUND
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    PMID: 18344392BACKGROUND
  • Kuo AD, Donelan JM. Dynamic principles of gait and their clinical implications. Phys Ther. 2010 Feb;90(2):157-74. doi: 10.2522/ptj.20090125. Epub 2009 Dec 18.

    PMID: 20023002BACKGROUND
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    PMID: 20222128BACKGROUND
  • MONTEIRO, E.P et al. Aspectos biomecânicos da locomoção de pessoas com doença de Parkinson: revisão narrativa. Revista Brasileira de Ciências do Esporte, ago. 2016. doi.org/10.1016/j.rbce.2016.07.003

    BACKGROUND
  • 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.

    PMID: 26833853BACKGROUND
  • 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
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    BACKGROUND
  • 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
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    BACKGROUND
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    BACKGROUND
  • 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
  • Wild LB, de Lima DB, Balardin JB, Rizzi L, Giacobbo BL, Oliveira HB, de Lima Argimon II, Peyre-Tartaruga LA, Rieder CR, Bromberg E. Characterization of cognitive and motor performance during dual-tasking in healthy older adults and patients with Parkinson's disease. J Neurol. 2013 Feb;260(2):580-9. doi: 10.1007/s00415-012-6683-3. Epub 2012 Sep 29.

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MeSH Terms

Conditions

Parkinson DiseaseParkinson Disease 10Movement Disorders

Interventions

Nordic WalkingJoggingExercise Movement Techniques

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

WalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor ActivityRunningPhysical Therapy ModalitiesTherapeutics

Study Officials

  • Leonardo Alexandre Peyré-Tartaruga, PhD

    Federal University of Rio Grande do Sul

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double-blind (Investigator, Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

December 5, 2018

First Posted

March 4, 2019

Study Start

August 1, 2018

Primary Completion

July 30, 2019

Study Completion

December 30, 2022

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations