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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763891
• Other study ID #: 555
• Status: Completed
• Phase: N/A
• First received: April 28, 2016
• Last updated: November 24, 2016
• Start date: September 2015
• Est. completion date: May 2016

Study information

• Verified date: November 2016
• Source: Pontificia Universidade Católica do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Intervention group (Body body suspension and tilting exercises)
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.
• Control group (global muscle stretching)
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.

Locations

Country	Name	City	State
Brazil	Serviço de Neurologia do Hospital São Lucas da PUCRS	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidade Católica do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hoehn and Yahr Staging of Parkinson's Disease	The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress.	This test will be performed just at baseline (to classify the subjects).	No
Primary	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.	At 8th week (in the end of exercise protocol).	No
Secondary	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.	At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).	No
Secondary	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.	At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).	No
Secondary	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).	At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).	No
Secondary	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.	At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).	No
Secondary	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.	At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).	No
Secondary	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.	At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).	No