Parkinson's DiseaseNCT00890669
Treadmill Training and Quality of Life in Parkinson's Disease
A study testing Treadmill walking training with additional body load in people with Parkinson's Disease, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
Parkinson's disease (PD) causes motor and non-motor impairments that affect the quality of life of the subjects. The purpose was to assess the effects of treadmill walking training with additional body load on the quality of life and motor symptoms of the subjects with PD. Read more about this study
- Who is it for?
- Ages 51 to 81 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Treadmill walking training with additional body load
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2007to Dec 2008
- 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 51 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hoehn and Yahr (H-Y) stages 2 through 3
- Absence of dementia (Mini-Mental Status Examination - MMSE, defined according to educational level)
- Capacity to ambulate independently for at least 10 meters
Who cannot join
- Change medication (dopaminergic) during the study period
- Use treadmill for at least six months prior to the study
- Other neurologic problems or musculoskeletal, cardiovascular and respiratory disease or uncorrected visual deficit that could represent risk and interfere in the accomplishment of the training
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de São Carlos
São Carlos, São Paulo, 13565-905
About this study
Official title: Treadmill Walking Training With Additional Body Load Improves Quality of Life in Subjects With Parkinson's Disease
Parkinson's disease (PD) causes motor and non-motor impairments that affect the quality of life of the subjects. The purpose was to assess the effects of treadmill walking training with additional body load on the quality of life and motor symptoms of the subjects with PD.
Methods: Nine subjects with PD, Hoehn and Yahr stages 2 through 3, not demented and with capability to ambulate independently voluntarily participate in this study. The training program was divided into three phases (A1-B-A2): treadmill training with additional body load (A1), control condition (conventional physical therapy group) (B) and treadmill training with load again (A2). Each phase lasted six weeks. The quality of life and motor symptoms were assessed by PDQ-39 and UPDRS, respectively. Both evaluations and training were performed during on-phase of the medication cycle.
- Conditions
- Parkinson's Disease
- Being tested
- Treadmill walking training with additional body load
- Keywords
- treadmill training, body load, quality of life, Parkinson's disease, Motor Symptoms
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill walking training with additional body loadOther
The training program was divided into three phases (A1-B-A2):
- treadmill training with additional body load (A1),
- control condition (conventional physical therapy group) (B). and
- treadmill training with additional body load again (A2).
Each phase lasted six weeks, totaling 18 weeks. Both evaluations and training were performed during on-phase of the medication cycle.
| Study group | Role | What they receive |
|---|---|---|
| PD Group | Experimental | Nine subjects with idiopathic PD, previously diagnosed by one specialist physician participated in this study. Receives: Other: Treadmill walking training with additional body load |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of life was measured through Parkinson Disease Questionnaire (PDQ-39).
Measured: 4 times, once before treatment, and 3 after each treatment phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startAug 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Investigators
- Nadiesca T Filippin, MSc, Principal investigator, Universidade Federal de Sao CarlosRosana Mattioli, PhD, Study chair, Universidade Federal de Sao CarlosPaula H Lobo da Costa, PhD, Study director, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890669
- Sponsor's protocol ID
- 234/07
- Other IDs
- CEP/UFSCar
- Status last verified
- May 2009
- First submitted
- 28 Apr 2009
- Last updated
- 4 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treadmill Walking Training With Additional Body Load Improves Quality of Life in Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00890669
- Acronym / sponsor ID
- 234/07
- Conditions
- Parkinson's Disease
- Keywords
- treadmill training, body load, quality of life, Parkinson's disease, Motor Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Aug 2007
- Study completion
- Dec 2008 (actual)
- First posted
- 30 Apr 2009 (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.
Parkinson's disease (PD) causes motor and non-motor impairments that affect the quality of life of the subjects. The purpose was to assess the effects of treadmill walking training with additional body load on the quality of life and motor symptoms of the subjects with PD.
Methods: Nine subjects with PD, Hoehn and Yahr stages 2 through 3, not demented and with capability to ambulate independently voluntarily participate in this study. The training program was divided into three phases (A1-B-A2): treadmill training with additional body load (A1), control condition (conventional physical therapy group) (B) and treadmill training with load again (A2). Each phase lasted six weeks. The quality of life and motor symptoms were assessed by PDQ-39 and UPDRS, respectively. Both evaluations and training were performed during on-phase of the medication cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD Group | Experimental | Other: Treadmill walking training with additional body loadNine subjects with idiopathic PD, previously diagnosed by one specialist physician participated in this study. |
Who may qualify
- Ages
- 51 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hoehn and Yahr (H-Y) stages 2 through 3
- Absence of dementia (Mini-Mental Status Examination - MMSE, defined according to educational level)
- Capacity to ambulate independently for at least 10 meters
Key exclusion criteria (3 listed)
- Change medication (dopaminergic) during the study period
- Use treadmill for at least six months prior to the study
- Other neurologic problems or musculoskeletal, cardiovascular and respiratory disease or uncorrected visual deficit that could represent risk and interfere in the accomplishment of the training
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 |
|---|---|---|
| Treadmill walking training with additional body loadThe training program was divided into three phases (A1-B-A2): * treadmill training with additional body load (A1), * control condition (conventional physical therapy group) (B). and * treadmill training with additional body load again (A2). Each phase lasted six weeks, totaling 18 weeks. Both evaluations and training were performed during on-phase of the medication cycle. | Other | PD Group |
Primary outcome
The quality of life was measured through Parkinson Disease Questionnaire (PDQ-39).
Time frame: 4 times, once before treatment, and 3 after each treatment phase.
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 4 May 2009.
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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.
Nadiesca T Filippin, MSc principal investigator
Universidade Federal de Sao Carlos
Rosana Mattioli, PhD study chair
Universidade Federal de Sao Carlos
Paula H Lobo da Costa, PhD study director
Universidade Federal de Sao Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill walking training with additional body load in people with Parkinson's Disease, run by Universidade Federal de Sao Carlos 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 3 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 4 May 2009. 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. 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?
The quality of life was measured through Parkinson Disease Questionnaire (PDQ-39). (time frame: 4 times, once before treatment, and 3 after each treatment phase.). 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 4 May 2009.