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Safety Study to Autonomic Rehabilitation o Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise
Sponsored by
Universidade Metodista de Piracicaba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease focused on measuring Parkinson's disease, Heart Rate Variability, Physiotherapy

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Universidade da Amazônia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Parkinson's Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

Full Information

First Posted
January 29, 2016
Last Updated
February 8, 2016
Sponsor
Universidade Metodista de Piracicaba
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1. Study Identification

Unique Protocol Identification Number
NCT02680522
Brief Title
Safety Study to Autonomic Rehabilitation o Parkinson's Disease
Official Title
Study of Modulation Autonomic Heart Rate of Individuals With Parkinson's Disease and Healty Individuals Subject to a Training With Virtual Reality
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Metodista de Piracicaba

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
To verify that the baseline conditions were adequate for the start of the collection, the volunteer remained 15 minutes at rest in supine position . They were measured and recorded : blood pressure by auscultation , using a mercury sphygmomanometer and a stethoscope ; and heart rate at rest by a heart rate monitor , with all measures carried out by the same researcher . Then the volunteer remained in the same position and was initiated to collect data 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 compatible for Polar softwere , the data being further processed into .txt format. For the analysis we used the Kubius HRV Analysis Version 2.0 software (Kuopio, Finland). From the choice of the most stable stretch of five minutes, HRV was analyzed in the time domain (TD) and the variables selected the RR interval, the square root square mean difference between normal adjacent iR-R expressed in milliseconds (RMSSD) and SDNN, in the frequency domain via LF, HF and LF / HF addition to the non-linear analysis with the contents SD1, SD2 and Shannon Entropy. To carry out the treatment with virtual reality Xbox 360® video game was the (Microsoft) used, the KinectTM Sensor, the kinectTM Adventures !, games with 6 modes and different phases and kinectTM Sports: Ultimate collection with 8 sports and different phases and TV Philips® the mark of 42 inches. The selected games were only the balance category, attention and planning, which consists of ten games, but only eight were used, including Kinect Sports game - "Tennis", "golf", "Ski" and the Kinect Adventure - "space bubble", "rapids", "top of the reflexes," "Hall of ricochets" and "leaks". Before the first virtual training session , the presentation of the goals of each of the games and an adaptation session was held , where the therapists were next to the volunteer performing verbal commands . During the Games volunteers remained in the standing position and barefoot . The volunteers performed 24 sessions in pairs, supervised by researchers for three times a week , every other day , lasting an hour each session. The scheduling range of care was organized so that the GP volunteers were always trained in the ON period of medication.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, Heart Rate Variability, Physiotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
composed of healthy volunteers who underwent training with virtual reality. Exercises with game through virtual reality
Arm Title
Parkinson's Group
Arm Type
Experimental
Arm Description
composed of patients with Parkinson's disease and who underwent training with virtual reality. exercises with game through virtual reality
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
exercise training with virtual reality in videogame
Primary Outcome Measure Information:
Title
Heart Rate Variability
Description
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 .
Time Frame
evaluation before the beginning of the rehabilitation protocol and after 24 sessions (3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Maués, Ms
Organizational Affiliation
Amazon University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade da Amazônia
City
Belém
State/Province
Pará
ZIP/Postal Code
66060902
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Citations:
PubMed Identifier
24703891
Citation
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.
Results Reference
result
PubMed Identifier
18706440
Citation
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.
Results Reference
result
PubMed Identifier
18667809
Citation
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.
Results Reference
result
PubMed Identifier
16629763
Citation
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.
Results Reference
result
PubMed Identifier
20508185
Citation
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.
Results Reference
result
PubMed Identifier
11181850
Citation
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.
Results Reference
result
PubMed Identifier
21861404
Citation
Vasilenko AF, Shamurov IuS, Mironova TF. [Sinus node activity in Parkinson's disease]. Klin Med (Mosk). 2011;89(3):47-50. Russian.
Results Reference
result
PubMed Identifier
21871844
Citation
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.
Results Reference
result

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Safety Study to Autonomic Rehabilitation o Parkinson's Disease

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