Clinical trial NCT02763891: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Balance
Mobility
Trunk control
Lead sponsor: Pontificia Universidade Católica do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Timed Up and Go Test
timeFrame: At 8th week (in the end of exercise protocol).
Secondary outcomes:
measure: Berg Balance Test
timeFrame: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
measure: Functional Reach Test
timeFrame: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
measure: Baropodometry (Stabilometric parameters)
timeFrame: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
measure: Unified Parkinson Disease Rating Scale (UPDRS)
timeFrame: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
measure: Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
measure: Timed Up and Go Test
timeFrame: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Other outcomes:
measure: Hoehn and Yahr Staging of Parkinson's Disease
timeFrame: This test will be performed just at baseline (to classify the subjects).
Locations:
city: Porto Alegre
country: Brazil
facility: Serviço de Neurologia do Hospital São Lucas da PUCRS
state: Rio Grande do Sul
Study officials:
affiliation: Pontifícia Universidade Católica do Rio Grande do Sul
name: Irênio G da Silva Filho, PhD
role: STUDY_CHAIR
affiliation: Hospital de Clínicas de Porto Alegre
name: Carlos Roberto M Rieder, PhD
role: STUDY_CHAIR
affiliation: Pontifícia Universidade Católica do Rio Grande do Sul
name: Régis G Mestriner, PhD
role: STUDY_DIRECTOR
affiliation: Pontifícia Universidade Católica do Rio Grande do Sul
name: Charlene B de Oliveira, MSc
role: PRINCIPAL_INVESTIGATOR
References: