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Effect of Body Suspension and Tilting Exercises in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Intervention group (Body body suspension and tilting exercises)
Control group (global muscle stretching)
Sponsored by
Pontificia Universidade Católica do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease focused on measuring Balance, Mobility, Trunk control

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects able to go to training or assessment places;
  • Subjects that are agreement with the study protocol and sign the ;
  • Subjects in stage I, II or III of Parkinson disease according to the Hoehn and Yahr scale.

Exclusion Criteria:

  • Subjects do not keep their usual routine (apart of the research protocol);
  • Subjects with physical or functional limitations that prevent the assessment test battery;
  • Subjects with heart or lung diseases that prevent the exercise performance;
  • Subjects with cancer;
  • Subjects with major visual deficits;
  • Subjects with recurrent vertigo;
  • Subjects with uncontrolled systemic blood pressure.

Sites / Locations

  • Serviço de Neurologia do Hospital São Lucas da PUCRS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention group

Control group

Arm Description

Subjects submitted to a 30-minute session of suspension and tilting exercises on the Chordata equipment (PI: 0804871-1 and BR 10 2012 009901-2) twice a week for eight weeks.

Subjects submitted to a 30-minute passive muscle stretching session twice a week for eight weeks.

Outcomes

Primary Outcome Measures

Timed Up and Go Test
Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down. The person wears regular footwear and customary walking aid.

Secondary Outcome Measures

Berg Balance Test
The Berg Balance Scale (BBS) is a widely used clinical test of a person's static and dynamic balance abilities. For functional balance tests, the BBS is generally considered to be the gold standard. The test takes 15-20 minutes and comprises a set of 14 simple balance related tasks, ranging from standing up from a sitting position, to standing on one foot. The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.
Functional Reach Test
The Functional Reach test can be administered while the patient is standing. The patient is instructed to next to, but not touching, a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. The assessor records the starting position at the 3rd metacarpal head on the yardstick. Instruct the patient to "Reach as far as you can forward without taking a step." The location of the 3rd metacarpal is recorded in centimetre (cm). Scores are determined by assessing the difference between the start and end position is the reach distance. Three trials are done and the average of the last two is noted.
Baropodometry (Stabilometric parameters)
In the test protocol adopted data uptake of the examination will be assessed walking on the pressure platform (dynamic measure) and stopped on the pressure platform with opened eyes (static measure).
Unified Parkinson Disease Rating Scale (UPDRS)
The UPDRS is a rating tool to follow the longitudinal course of Parkinson's Disease. It is made up of the 1) Mentation, Behavior, and Mood, 2) ADL and 3) Motor sections. These are evaluated by interview. Some sections require multiple grades assigned to each extremity. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability.
Parkinson's Disease Questionnaire (PDQ-39)
The Parkinson's Disease Questionnaire (PDQ-39) is primarily used in clinical trials of therapeutics intended to benefit individuals with Parkinson's disease.
Timed Up and Go Test
Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down. The person wears regular footwear and customary walking aid. The investigators will measure the "change" at different time frames.

Full Information

First Posted
April 28, 2016
Last Updated
November 24, 2016
Sponsor
Pontificia Universidade Católica do Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT02763891
Brief Title
Effect of Body Suspension and Tilting Exercises in Parkinson's Disease
Official Title
Effect of Body Suspension and Tilting Exercises in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidade Católica do Rio Grande do Sul

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the effect of body suspension and tilting exercises (performed in Chordata apparatus) on the balance and mobility of subjects with Parkinson disease. Half of patients will perform the exercise protocol while the other half will receive passive muscle stretching and maintain the usual routine.
Detailed Description
Body suspension and tilting exercises performed in the Chordata equipment might be an effective option to improve trunk muscles activation and to facilitate functional balance and mobility control in Parkinson's disease (PD). To evaluate this hypothesis, subjects will be randomized into control group or intervention group. Intervention group will receive 30-minute session of body suspension and tilting exercises on the Chordata equipment (PI: 0804871-1 and BR 10 2012 009901-2) twice a week for eight weeks, while the control group will receive passive muscle stretching and maintained their usual routine during the same period. Both groups will be assessed at baseline and immediately after the intervention protocol. Finally, a follow-up evaluation will be performed 8 weeks after the protocol ending (to verify possible long-lasting effects of this exercise protocol).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Balance, Mobility, Trunk control

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Subjects submitted to a 30-minute session of suspension and tilting exercises on the Chordata equipment (PI: 0804871-1 and BR 10 2012 009901-2) twice a week for eight weeks.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Subjects submitted to a 30-minute passive muscle stretching session twice a week for eight weeks.
Intervention Type
Other
Intervention Name(s)
Intervention group (Body body suspension and tilting exercises)
Other Intervention Name(s)
Chordata body suspension and tilting
Intervention Description
The body suspension and tilting exercise program (Chordata Method) involved suspending the body in the apparatus while performing tilting exercises. The Chordata apparatus consists of a steel structure with special springs and a harness specifically manufactured for practicing the Chordata Method. During the training sessions, the prescribed exercises emphasize the repetition of movements designed to promote different types of muscle contractions (concentric, eccentric, static) performed in different body positions and joint angles. Thus, when using the method, patients experience maximal functional performance beyond to the body mass centre, activating trunk antagonist muscles and motor memory evocation. Each session lasts 30 minutes.
Intervention Type
Other
Intervention Name(s)
Control group (global muscle stretching)
Other Intervention Name(s)
Control
Intervention Description
Subjects receiving submitted a global muscle stretching session twice a week for eight weeks. During this period. All participants are requested to don't engage in any additional type of exercise program or physical activity throughout the study period.
Primary Outcome Measure Information:
Title
Timed Up and Go Test
Description
Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down. The person wears regular footwear and customary walking aid.
Time Frame
At 8th week (in the end of exercise protocol).
Secondary Outcome Measure Information:
Title
Berg Balance Test
Description
The Berg Balance Scale (BBS) is a widely used clinical test of a person's static and dynamic balance abilities. For functional balance tests, the BBS is generally considered to be the gold standard. The test takes 15-20 minutes and comprises a set of 14 simple balance related tasks, ranging from standing up from a sitting position, to standing on one foot. The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.
Time Frame
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Title
Functional Reach Test
Description
The Functional Reach test can be administered while the patient is standing. The patient is instructed to next to, but not touching, a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. The assessor records the starting position at the 3rd metacarpal head on the yardstick. Instruct the patient to "Reach as far as you can forward without taking a step." The location of the 3rd metacarpal is recorded in centimetre (cm). Scores are determined by assessing the difference between the start and end position is the reach distance. Three trials are done and the average of the last two is noted.
Time Frame
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Title
Baropodometry (Stabilometric parameters)
Description
In the test protocol adopted data uptake of the examination will be assessed walking on the pressure platform (dynamic measure) and stopped on the pressure platform with opened eyes (static measure).
Time Frame
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Title
Unified Parkinson Disease Rating Scale (UPDRS)
Description
The UPDRS is a rating tool to follow the longitudinal course of Parkinson's Disease. It is made up of the 1) Mentation, Behavior, and Mood, 2) ADL and 3) Motor sections. These are evaluated by interview. Some sections require multiple grades assigned to each extremity. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability.
Time Frame
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Title
Parkinson's Disease Questionnaire (PDQ-39)
Description
The Parkinson's Disease Questionnaire (PDQ-39) is primarily used in clinical trials of therapeutics intended to benefit individuals with Parkinson's disease.
Time Frame
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Title
Timed Up and Go Test
Description
Measurement of the time in seconds for a person to rise from sitting from a standard arm chair, walk 3 meters, turn, walk back to the chair, and sit down. The person wears regular footwear and customary walking aid. The investigators will measure the "change" at different time frames.
Time Frame
At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Other Pre-specified Outcome Measures:
Title
Hoehn and Yahr Staging of Parkinson's Disease
Description
The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress.
Time Frame
This test will be performed just at baseline (to classify the subjects).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects able to go to training or assessment places; Subjects that are agreement with the study protocol and sign the ; Subjects in stage I, II or III of Parkinson disease according to the Hoehn and Yahr scale. Exclusion Criteria: Subjects do not keep their usual routine (apart of the research protocol); Subjects with physical or functional limitations that prevent the assessment test battery; Subjects with heart or lung diseases that prevent the exercise performance; Subjects with cancer; Subjects with major visual deficits; Subjects with recurrent vertigo; Subjects with uncontrolled systemic blood pressure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irênio G da Silva Filho, PhD
Organizational Affiliation
Pontifícia Universidade Católica do Rio Grande do Sul
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carlos Roberto M Rieder, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Régis G Mestriner, PhD
Organizational Affiliation
Pontifícia Universidade Católica do Rio Grande do Sul
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Charlene B de Oliveira, MSc
Organizational Affiliation
Pontifícia Universidade Católica do Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Serviço de Neurologia do Hospital São Lucas da PUCRS
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Body Suspension and Tilting Exercises in Parkinson's Disease

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