NCT02680522

Brief Summary

Introduction: The Parkinson is one of the most common degenerative diseases of the central nervous system , mainly characterized by resting tremor , rigidity, akinesia and postural instability , also featuring the autonomic modulation of heart rate , which can lead to reduced frequency variability heart . Some activities may modify the modulation , including rehabilitation using virtual reality. Method: The research is interventional type , quantity and prospective, where volunteers were chosen for inclusion and exclusion criteria and divided into two groups , Control and Parkinson's, where they underwent 24 sections with virtual reality physiotherapy three times a week . Analysis of the autonomic modulation of heart rate was performed before and after the rehabilitation program with the frequency meter Polar brand. Statistical analysis was performed in 5.2 Biostat program with Shapiro- Wilk test to verify the normality , followed by t test to compare the data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

January 29, 2016

Last Update Submit

February 8, 2016

Conditions

Parkinson Disease

Keywords

Parkinson's diseaseHeart Rate VariabilityPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Heart Rate Variability

    Data collection with the registration of iR-R by Polar heart rate monitor model RS800CX (Polar Electro Co.Ltda. Kempele, Finland) for 15 min. During the registration time, the participants maintained spontaneous respiration, were told not to talk, not sleep and avoid sudden movements. Subsequently, the recorded iR-R were transferred via an interface to a computer. For the analysis we used the Kubius HRV Analysis Version 2.0 software (Kuopio, Finland). 50 volunteers evaluation with Parkinson's disease and 50 healthy volunteers to investigate the improvement of autonomic modulation. all volunteers will be evaluated after three months of the end of the rehabilitation protocol in order to investigate whether the protocol improved the autonomic modulation in patients with Parkinson 's disease .

    evaluation before the beginning of the rehabilitation protocol and after 24 sessions (3 months)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

composed of healthy volunteers who underwent training with virtual reality. Exercises with game through virtual reality

Other: Exercise

Parkinson's Group

EXPERIMENTAL

composed of patients with Parkinson's disease and who underwent training with virtual reality. exercises with game through virtual reality

Other: Exercise

Interventions

ExerciseOTHER

exercise training with virtual reality in videogame

Control GroupParkinson's Group

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of Parkinson's Disease confirmed by medical evidence
  • disease progression between three and ten years
  • ranked between levels 2-3 in the modified Hoehn and Yahr
  • with higher scores 24 or classified as illiterate score for the Mini-Mental State Examination.

You may not qualify if:

  • With breathing problems induced by exercise
  • orthopedic diseases
  • with visual and / or hearing impairment
  • uncontrolled hypertension
  • use of vasoactive drugs
  • which have performed heart surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade da Amazônia

Belém, Pará, 66060902, Brazil

Location

Related Publications (8)

  • Pompeu JE, Arduini LA, Botelho AR, Fonseca MB, Pompeu SM, Torriani-Pasin C, Deutsch JE. Feasibility, safety and outcomes of playing Kinect Adventures! for people with Parkinson's disease: a pilot study. Physiotherapy. 2014 Jun;100(2):162-8. doi: 10.1016/j.physio.2013.10.003. Epub 2013 Dec 27.

    PMID: 24703891RESULT

  • Montano N, Porta A, Cogliati C, Costantino G, Tobaldini E, Casali KR, Iellamo F. Heart rate variability explored in the frequency domain: a tool to investigate the link between heart and behavior. Neurosci Biobehav Rev. 2009 Feb;33(2):71-80. doi: 10.1016/j.neubiorev.2008.07.006. Epub 2008 Jul 30.

    PMID: 18706440RESULT

  • Broeren J, Claesson L, Goude D, Rydmark M, Sunnerhagen KS. Virtual rehabilitation in an activity centre for community-dwelling persons with stroke. The possibilities of 3-dimensional computer games. Cerebrovasc Dis. 2008;26(3):289-96. doi: 10.1159/000149576. Epub 2008 Jul 31.

    PMID: 18667809RESULT

  • Mihci E, Kardelen F, Dora B, Balkan S. Orthostatic heart rate variability analysis in idiopathic Parkinson's disease. Acta Neurol Scand. 2006 May;113(5):288-93. doi: 10.1111/j.1600-0404.2006.00580.x.

    PMID: 16629763RESULT

  • Saposnik G, Teasell R, Mamdani M, Hall J, McIlroy W, Cheung D, Thorpe KE, Cohen LG, Bayley M; Stroke Outcome Research Canada (SORCan) Working Group. Effectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle. Stroke. 2010 Jul;41(7):1477-84. doi: 10.1161/STROKEAHA.110.584979. Epub 2010 May 27.

    PMID: 20508185RESULT

  • Haapaniemi TH, Pursiainen V, Korpelainen JT, Huikuri HV, Sotaniemi KA, Myllyla VV. Ambulatory ECG and analysis of heart rate variability in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2001 Mar;70(3):305-10. doi: 10.1136/jnnp.70.3.305.

    PMID: 11181850RESULT

  • Vasilenko AF, Shamurov IuS, Mironova TF. [Sinus node activity in Parkinson's disease]. Klin Med (Mosk). 2011;89(3):47-50. Russian.

    PMID: 21861404RESULT

  • Niwa F, Kuriyama N, Nakagawa M, Imanishi J. Circadian rhythm of rest activity and autonomic nervous system activity at different stages in Parkinson's disease. Auton Neurosci. 2011 Dec 7;165(2):195-200. doi: 10.1016/j.autneu.2011.07.010. Epub 2011 Aug 25.

    PMID: 21871844RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sarah Maués, Ms

    Amazon University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student of the program in science of human movement

Study Record Dates

First Submitted

January 29, 2016

First Posted

February 11, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 11, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

The data of the volunteers will be kept confidential , being only used the amount of data for publication in journals with the period until 2017

Locations

BR(1)