Parkinson DiseaseNCT02023034
Virtual Exercises in Patients With Parkinson's Disease.
A study testing Virtual exercises in people with Parkinson Disease, run by Faculdade Evangelica do Parana at 1 site in Brazil.
Trial summary
Introduction: Although the motor changes are well determined in Parkinson's disease (PD), few studies describe the effects the virtual exercises on the clinical and functional outcomes in this disease. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Virtual exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2013to Feb 2014
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- will be selected for the study
- subjects with a clinical diagnosis of Parkinson's disease
- 0-III H\&Y
- 40 to 80 years
- both sexes
- with preserved cognitive stage (Mini Mental> 24).
Who cannot join
- will be excluded subjects who have some acute pain or associated diseases
- such as severe or unstable heart disease
- visual disturbances
- using some march auxiliary device, which compromise the 6MWT and exercise protocol
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Associação Paranaense dos Portadores de Parkinsonismo
Curitiba, Paraná
About this study
Official title: EFFECTIVENESS OF VIRTUAL EXERCISES ON THE FUNCTIONAL EXERCISE CAPACITY, FATIGUE AND QUALITY OF LIFE IN PATIENTS WITH PARKINSON'S DISEASE: A RANDOMIZED CLINICAL TRIAL
Introduction: Although the motor changes are well determined in Parkinson's disease (PD), few studies describe the effects the virtual exercises on the clinical and functional outcomes in this disease.
Objectives: To analyze the effectiveness of virtual exercises on functional exercise capacity, fatigue and quality of life in patients with PD.
Read more
Methods: 20 subjects, 60 years old will be included, who will be randomized into 2 groups: group of virtual exercises associated with conventional exercises (n = 10) and control group with conventional exercise group (n = 10).
The following variables are evaluated: functional exercise through walking test in 6 minutes, fatigue by the Fatigue Severity Scale and Quality of Life through Quality of Life Questionnaire-PDQ-39.
- Conditions
- Parkinson Disease
- Being tested
- Virtual exercises
- Keywords
- Parkinson disease, Physical Therapy, Fatigue, Quality of Life
- Medical subject headings
- Parkinson Disease, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual exercisesOther
The exercises will be performed with the Nintendo ® Wii Balance Board ® platform, and consist in: 1) Table Tilt; 2) Obstacle Course; 3) Tilt City; 4) Basic step; 5) Penguin; 6) Heading Soccer; 7) Basic Run. All patients underwent 12 sessions, twice a week for a period of 06 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Virtual exercises | Experimental | All patients underwent 12 sessions, twice a week for a period of 06 weeks. The exercises were performed in the "on" dopaminergic medication, supervised by the researchers, the period instrument used was the video game with the Nintendo ® Wii Balance Board ® platform. Receives: Other: Virtual exercises |
| Control | Sham comparator | Traditional exercises. All patients underwent 12 sessions, twice a week for a period of 06 weeks. The exercises were performed in the "on" dopaminergic medication, supervised by the researchers. Receives: Other: Virtual exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of functional exercise capacity
Assessed by the 6-minute walk test (6MWT), according to the guidelines of the American Thoracic Society, which is based on the evaluation of the maximum distance traveled by the patient for six minutes, expressed in meters.
Measured: The subjects will be followed for a period of 90 days.
Secondary outcomes (1)
Reduction of Fatigue
Assessed by the Fatigue Severity Scale, which consists of a questionnaire that assesses the impact of fatigue-related activities of daily living, rating ranges from 1 to 7 where 1 indicates little tired and 7, very tired.
Measured: The subjects will be followed for a period of 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionFeb 2014
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade Evangelica do Parana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Valderramas, Faculdade Evangelica do Parana
- Investigators
- Silvia Valderramas, PhD, Principal investigator, Faculdade Evangelica do Parana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023034
- Sponsor's protocol ID
- FEPAR - 04
- Status last verified
- Jul 2019
- First submitted
- 23 Dec 2013
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF VIRTUAL EXERCISES ON THE FUNCTIONAL EXERCISE CAPACITY, FATIGUE AND QUALITY OF LIFE IN PATIENTS WITH PARKINSON'S DISEASE: A RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT02023034
- Acronym / sponsor ID
- FEPAR - 04
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Physical Therapy, Fatigue, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Faculdade Evangelica do ParanaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 30 Dec 2013 (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.
Introduction: Although the motor changes are well determined in Parkinson's disease (PD), few studies describe the effects the virtual exercises on the clinical and functional outcomes in this disease.
Objectives: To analyze the effectiveness of virtual exercises on functional exercise capacity, fatigue and quality of life in patients with PD.
Methods: 20 subjects, 60 years old will be included, who will be randomized into 2 groups: group of virtual exercises associated with conventional exercises (n = 10) and control group with conventional exercise group (n = 10).
The following variables are evaluated: functional exercise through walking test in 6 minutes, fatigue by the Fatigue Severity Scale and Quality of Life through Quality of Life Questionnaire-PDQ-39.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual exercises | Experimental | Other: Virtual exercisesAll patients underwent 12 sessions, twice a week for a period of 06 weeks. The exercises were performed in the "on" dopaminergic medication, supervised by the researchers, the period instrument used was the video game with the Nintendo ® Wii Balance Board ® platform. |
| Control | Sham comparator | Other: Virtual exercisesTraditional exercises. All patients underwent 12 sessions, twice a week for a period of 06 weeks. The exercises were performed in the "on" dopaminergic medication, supervised by the researchers. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- will be selected for the study
- subjects with a clinical diagnosis of Parkinson's disease
- 0-III H\&Y
- 40 to 80 years
- both sexes
Key exclusion criteria (4 listed)
- will be excluded subjects who have some acute pain or associated diseases
- such as severe or unstable heart disease
- visual disturbances
- using some march auxiliary device, which compromise the 6MWT and exercise protocol
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 |
|---|---|---|
| Virtual exercisesThe exercises will be performed with the Nintendo ® Wii Balance Board ® platform, and consist in: 1) Table Tilt; 2) Obstacle Course; 3) Tilt City; 4) Basic step; 5) Penguin; 6) Heading Soccer; 7) Basic Run. All patients underwent 12 sessions, twice a week for a period of 06 weeks. | Other | Control, Virtual exercises |
Primary outcome
Improvement of functional exercise capacity
Time frame: The subjects will be followed for a period of 90 days.
Assessed by the 6-minute walk test (6MWT), according to the guidelines of the American Thoracic Society, which is based on the evaluation of the maximum distance traveled by the patient for six minutes, expressed in meters.
1 secondary outcome
Reduction of Fatigue
Time frame: The subjects will be followed for a period of 90 days.
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 1 Aug 2019.
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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.
Silvia Valderramas, PhD principal investigator
Faculdade Evangelica do Parana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual exercises in people with Parkinson Disease, run by Faculdade Evangelica do Parana 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 6 inclusion and 4 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 1 Aug 2019. 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?
Improvement of functional exercise capacity (time frame: The subjects will be followed for a period of 90 days.). 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 1 Aug 2019.