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

NCT ID: NCT02763891

Last Updated: 2016-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-05-31

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).

Conditions

Parkinson Disease

Keywords

Balance; Mobility; Trunk control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Intervention group (Body body suspension and tilting exercises)

Intervention Type: 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.

Control group

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

Group Type: SHAM_COMPARATOR

Control group (global muscle stretching)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

Chordata body suspension and tilting; Control

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pontificia Universidade Católica do Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irênio G da Silva Filho, PhD

Role: STUDY_CHAIR

Pontifícia Universidade Católica do Rio Grande do Sul

Carlos Roberto M Rieder, PhD

Role: STUDY_CHAIR

Hospital de Clínicas de Porto Alegre

Régis G Mestriner, PhD

Role: STUDY_DIRECTOR

Pontifícia Universidade Católica do Rio Grande do Sul

Charlene B de Oliveira, MSc

Role: PRINCIPAL_INVESTIGATOR

Pontifícia Universidade Católica do Rio Grande do Sul

Locations

Serviço de Neurologia do Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

555

Identifier Type: -

Identifier Source: org_study_id