Parkinson's DiseaseNCT02745171
Continuous Behavior Assessment of the Effects of a Physical Therapy Program for Patients With Parkinson's Disease
A study testing physical therapy in people with Parkinson's Disease, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Introduction: Parkinson's disease (PD) results from dysfunction of the dopaminergic system of degenerative and progressive, with changes in the nigrostriatal pathway, and decreased concentration of dopamine. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2016to Jun 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Idiopathic Parkinson's disease according to the Bank of London Brain (Hughes et al, 1992);
- Both sexes;
- Patients in stages 1 through 3 for this modified version of the Hoehn \& Yahr scale (HY);
- the patient Agreement to participate in the research after explanation and understanding of it and signing the Consent and Informed.
Who cannot join
- cognitive disorder identified by the Mini-Mental State Examination as schooling ;
- Patients with other neurological diseases;
- initiate other rehabilitative treatment throughout and after the physical therapy program.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Pernambuco
Recife, Pernambuco, 50670-901
Bruna P Prudente, (81)99728-0870, brubrupp@hotmail.com
About this study
Introduction: Parkinson's disease (PD) results from dysfunction of the dopaminergic system of degenerative and progressive, with changes in the nigrostriatal pathway, and decreased concentration of dopamine. Has as clinical signs, symptoms called cardinal engines: resting tremor, bradykinesia, rigidity and postural instability. In addition to drug therapy, physical therapy is also considered a useful tool for the treatment of motor disorders of the disease. The role of physiotherapy aims to stimulate the security and independence of patients with PD in carrying out activities and to preserve and improve physical function. Some studies have shown the negative effect of the disease on quality of life and functional mobility. Few studies have been conducted to evaluate the effects of long-term therapy in PD, but many report the beneficial effects of a rehabilitation program in a short period of time.
Objective: To continually assess the effects after the completion of a physical therapy program in patients with Parkinson's disease.
Methods: Type study randomized double blind clinical trial in Parkinson Pro Program Hospital of the Federal University of Pernambuco. Will be recruited subjects with PD, both sexes, in stages 1 to 3 on the scale of Hoehn Yahr and score greater than 18 on the Mini-Mental. Patients who are recruited will undergo an assessment using the scales of assessment of functional mobility, quality of life and motor examination before starting physical therapy at the end of treatment and two months after completion of treatment, and the intervals assessments of a month.
Read the detailed description
The Parkinson's disease results from dysfunction of the dopaminergic systems, cholinergic, serotonergic and noradrenergic, though the neuropathological basic pattern is the change of the nigrostriatal pathway, with decreased concentration of dopamine at the level of dopamine receptors in the body striatum.
With still little known etiology in most instances, the Parkinson's disease has as clinical signs, symptoms called cardinal engines: resting tremor, bradykinesia, rigidity and postural instability. Additionally, patients may exhibit cognitive deficits and emotional changes with the progression of the disease.
The clinical diagnosis is primarily based on the identification of the cardinal motor symptoms plus the initial response to levodopa therapy . The literature is unanimous in admitting that the use of Levodopa (L-dopa) is the most effective drug for the treatment, and its administration the most recommended in satisfactory symptom control.
In addition to drug therapy, physical therapy is also considered a useful tool for the treatment of motor disorders associated disease. Although the speed of the motor of the patient learningParkinson's disease is lower than their control group of the same age, rehabilitation, these individuals may also acquire motor skills as well as improve their performance through practice repetition.
Although a physical rehabilitation program to be beneficial to improve the activities of daily living (ADL) and mobility in patients with Parkinson's disease , it is not yet clear how long its effect is sustained. Most clinical trials of physiotherapy in PD were based on short-term rehabilitation programs.
Few studies have been conducted to evaluate the effects of long-term physical therapy in Parkinson's disease, but many report the beneficial effects of a short-term rehabilitation program, without having to concern monitoring after the physical therapy.
Thus this study aims to continuously evaluate the behavior of the effects of a physical therapy program in patients with Parkinson's disease.
Knowledge of the time interval which is the decline of the gains from physiotherapy is a guiding point to guide the patient regarding their return to service for revaluation, also considering the fact that the disease have progressive.
- Conditions
- Parkinson's Disease
- Being tested
- physical therapy
- Keywords
- Parkinson's disease, Quality of life, Functional mobility, Follow up
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapyOther
Will be held 15 sessions, 2 times a week, lasting 50 minutes, a physical therapy protocol developed by the Pro-Parkinson Physiotherapy based on the Guide of the Dutch Society of Physiotherapy (Keus, 2004).
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | This group will be evaluated after three months there will be a reassessment, in this case the participating subjects do not perform any kind of therapy. |
| Experimental group | Experimental | There will be an initial evaluation, after a month of physical therapy at the end of the protocol, and twice more after the protocol, both interval a month. Receives: Other: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from quality of life
The PDQ-39 is a specific rating scale of QOL in PD and comprises 39 items that can be answered with five different response options: "never"; "On occasion"; "sometimes"; "often"; "Always" or "it is impossible for me."
Measured: change in quality of life, it is evaluated every month to complete the four-month period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2016
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIA DAS GRAÇAS WANDERLEY DE SALES CORIOLANO, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745171
- Sponsor's protocol ID
- 50967815.7.0000.5208
- Status last verified
- Apr 2016
- First submitted
- 30 Mar 2016
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Behavior Assessment of the Effects of a Physical Therapy Program for Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02745171
- Acronym / sponsor ID
- 50967815.7.0000.5208
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Quality of life, Functional mobility, Follow up
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 20 Apr 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.
Introduction: Parkinson's disease (PD) results from dysfunction of the dopaminergic system of degenerative and progressive, with changes in the nigrostriatal pathway, and decreased concentration of dopamine. Has as clinical signs, symptoms called cardinal engines: resting tremor, bradykinesia, rigidity and postural instability. In addition to drug therapy, physical therapy is also considered a useful tool for the treatment of motor disorders of the disease. The role of physiotherapy aims to stimulate the security and independence of patients with PD in carrying out activities and to preserve and improve physical function. Some studies have shown the negative effect of the disease on quality of life and functional mobility. Few studies have been conducted to evaluate the effects of long-term therapy in PD, but many report the beneficial effects of a rehabilitation program in a short period of time.
Objective: To continually assess the effects after the completion of a physical therapy program in patients with Parkinson's disease.
Methods: Type study randomized double blind clinical trial in Parkinson Pro Program Hospital of the Federal University of Pernambuco. Will be recruited subjects with PD, both sexes, in stages 1 to 3 on the scale of Hoehn Yahr and score greater than 18 on the Mini-Mental. Patients who are recruited will undergo an assessment using the scales of assessment of functional mobility, quality of life and motor examination before starting physical therapy at the end of treatment and two months after completion of treatment, and the intervals assessments of a month.
Detailed description
The Parkinson's disease results from dysfunction of the dopaminergic systems, cholinergic, serotonergic and noradrenergic, though the neuropathological basic pattern is the change of the nigrostriatal pathway, with decreased concentration of dopamine at the level of dopamine receptors in the body striatum.
With still little known etiology in most instances, the Parkinson's disease has as clinical signs, symptoms called cardinal engines: resting tremor, bradykinesia, rigidity and postural instability. Additionally, patients may exhibit cognitive deficits and emotional changes with the progression of the disease.
The clinical diagnosis is primarily based on the identification of the cardinal motor symptoms plus the initial response to levodopa therapy . The literature is unanimous in admitting that the use of Levodopa (L-dopa) is the most effective drug for the treatment, and its administration the most recommended in satisfactory symptom control.
In addition to drug therapy, physical therapy is also considered a useful tool for the treatment of motor disorders associated disease. Although the speed of the motor of the patient learningParkinson's disease is lower than their control group of the same age, rehabilitation, these individuals may also acquire motor skills as well as improve their performance through practice repetition.
Although a physical rehabilitation program to be beneficial to improve the activities of daily living (ADL) and mobility in patients with Parkinson's disease , it is not yet clear how long its effect is sustained. Most clinical trials of physiotherapy in PD were based on short-term rehabilitation programs.
Few studies have been conducted to evaluate the effects of long-term physical therapy in Parkinson's disease, but many report the beneficial effects of a short-term rehabilitation program, without having to concern monitoring after the physical therapy.
Thus this study aims to continuously evaluate the behavior of the effects of a physical therapy program in patients with Parkinson's disease.
Knowledge of the time interval which is the decline of the gains from physiotherapy is a guiding point to guide the patient regarding their return to service for revaluation, also considering the fact that the disease have progressive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –This group will be evaluated after three months there will be a reassessment, in this case the participating subjects do not perform any kind of therapy. |
| Experimental group | Experimental | Other: physical therapyThere will be an initial evaluation, after a month of physical therapy at the end of the protocol, and twice more after the protocol, both interval a month. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with Idiopathic Parkinson's disease according to the Bank of London Brain (Hughes et al, 1992);
- Both sexes;
- Patients in stages 1 through 3 for this modified version of the Hoehn \& Yahr scale (HY);
- the patient Agreement to participate in the research after explanation and understanding of it and signing the Consent and Informed.
Key exclusion criteria (3 listed)
- cognitive disorder identified by the Mini-Mental State Examination as schooling ;
- Patients with other neurological diseases;
- initiate other rehabilitative treatment throughout and after the physical therapy program.
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 |
|---|---|---|
| physical therapyWill be held 15 sessions, 2 times a week, lasting 50 minutes, a physical therapy protocol developed by the Pro-Parkinson Physiotherapy based on the Guide of the Dutch Society of Physiotherapy (Keus, 2004). | Other | Experimental group |
Primary outcome
change from quality of life
Time frame: change in quality of life, it is evaluated every month to complete the four-month period.
The PDQ-39 is a specific rating scale of QOL in PD and comprises 39 items that can be answered with five different response options: "never"; "On occasion"; "sometimes"; "often"; "Always" or "it is impossible for me."
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy in people with Parkinson's Disease, run by Universidade Federal de Pernambuco 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 4 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: status not confirmed, as of the sponsor's last update on 20 Apr 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria G Coriolano ((81)984768060, gracawander@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from quality of life (time frame: change in quality of life, it is evaluated every month to complete the four-month period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02745171, which also lists 2 linked publications.
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 20 Apr 2016.