Parkinson DiseaseNCT02763891
Effect of Body Suspension and Tilting Exercises in Parkinson's Disease
A study testing Intervention group (Body body suspension and tilting exercises) in people with Parkinson Disease, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Intervention group (Body body suspension and tilting exercises)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Serviço de Neurologia do Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul
About this study
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.
Read the 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
- Being tested
- Intervention group (Body body suspension and tilting exercises), Control group (global muscle stretching)
- Keywords
- Balance, Mobility, Trunk control
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group (Body body suspension and tilting exercises)Other
Also called Chordata body suspension and tilting
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)Other
Also called Control
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control group (global muscle stretching) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 8th week (in the end of exercise protocol).
Secondary outcomes (6)
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.
Measured: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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.
Measured: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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).
Measured: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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.
Measured: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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.
Measured: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
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.
Measured: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startSep 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irênio G da Silva Filho, PhD, Study chair, Pontifícia Universidade Católica do Rio Grande do SulCarlos Roberto M Rieder, PhD, Study chair, Hospital de Clinicas de Porto AlegreRégis G Mestriner, PhD, Study director, Pontifícia Universidade Católica do Rio Grande do SulCharlene B de Oliveira, MSc, Principal investigator, Pontifícia Universidade Católica do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763891
- Sponsor's protocol ID
- 555
- Status last verified
- Nov 2016
- First submitted
- 28 Apr 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Body Suspension and Tilting Exercises in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02763891
- Acronym / sponsor ID
- 555
- Conditions
- Parkinson Disease
- Keywords
- Balance, Mobility, Trunk control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do SulUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Intervention group (Body body suspension and tilting exercises)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. |
| Control group | Sham comparator | Other: Control group (global muscle stretching)Subjects submitted to a 30-minute passive muscle stretching session twice a week for eight weeks. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention group (Body body suspension and tilting exercises)Also: Chordata body suspension and tiltingThe 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. | Other | Intervention group |
| Control group (global muscle stretching)Also: ControlSubjects 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. | Other | Control group |
Primary outcome
Timed Up and Go Test
Time frame: At 8th week (in the end of exercise protocol).
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.
6 secondary outcomes
Berg Balance Test
Time frame: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Functional Reach Test
Time frame: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Baropodometry (Stabilometric parameters)
Time frame: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Unified Parkinson Disease Rating Scale (UPDRS)
Time frame: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Timed Up and Go Test
Time frame: At baseline, at 8th week (in the end of exercise protocol) and at 16th week (follow-up).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irênio G da Silva Filho, PhD study chair
Pontifícia Universidade Católica do Rio Grande do Sul
Carlos Roberto M Rieder, PhD study chair
Hospital de Clinicas de Porto Alegre
Régis G Mestriner, PhD study director
Pontifícia Universidade Católica do Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group (Body body suspension and tilting exercises) in people with Parkinson Disease, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go Test (time frame: At 8th week (in the end of exercise protocol).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.