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

NCT02763891 | Completed

• 1 other identifier: 555
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Balance; Mobility; Trunk control

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (6)

• Berg Balance Test

  At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).

• Functional Reach Test

  At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).

• Baropodometry (Stabilometric parameters)

  At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).

• Unified Parkinson Disease Rating Scale (UPDRS)

  At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).

• Parkinson's Disease Questionnaire (PDQ-39)

  At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).

Other Outcomes (1)

• Hoehn and Yahr Staging of Parkinson's Disease

  This test will be performed just at baseline (to classify the subjects).

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Other: Intervention group (Body body suspension and tilting exercises)

Control group

SHAM COMPARATOR

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

Other: Control group (global muscle stretching)

Interventions

Intervention group (Body body suspension and tilting exercises) OTHER

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.

Also known as: Chordata body suspension and tilting

Intervention group

Control group (global muscle stretching) OTHER

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.

Also known as: Control

Control group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidade Católica do Rio Grande do Sul: lead

Study Sites (1)

Serviço de Neurologia do Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Irênio G da Silva Filho, PhD

  Pontifícia Universidade Católica do Rio Grande do Sul

  STUDY CHAIR

• Carlos Roberto M Rieder, PhD

  Hospital de Clínicas de Porto Alegre

  STUDY CHAIR

• Régis G Mestriner, PhD

  Pontifícia Universidade Católica do Rio Grande do Sul

  STUDY DIRECTOR

• Charlene B de Oliveira, MSc

  Pontifícia Universidade Católica do Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 5, 2016
• Study Start: September 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 28, 2016

Record last verified: 2016-11

Locations

BR (1)