Parkinson DiseaseNCT02447146
Resistance Training in Patients With Parkinson's Disease.
A study testing Resistance Training and Lectures on the disease in people with Parkinson Disease, run by University of Brasilia.
Trial summary
This is a controlled trial to assess the effects of resistance training on bradykinesia and physical function in patients with Parkinson's Disease. Forty patients diagnosed with Parkinson Disease stage 1 to 3 of the Hoehn and Yahr scale took part in the study and were allocated into 2 groups; Training Group performed… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Resistance Training and Lectures on the disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medical neurologist confirmation of 1-3 Hoehn and Yahr stages,
- age between 50 and 80 years old;
- and physician attested to participate in the resistance training program.
Who cannot join
- Diagnostic of any other neurological disease, cardiovascular disease, hematologic or orthopedic disorders;
- and motor fluctuations or severe dyskinesia that could affect their ability to perform the experimental protocol.
About this study
Official title: Effects of Resistance Training on Bradykinesia and Physical Function in Patients With Parkinson's Disease.
This is a controlled trial to assess the effects of resistance training on bradykinesia and physical function in patients with Parkinson's Disease. Forty patients diagnosed with Parkinson Disease stage 1 to 3 of the Hoehn and Yahr scale took part in the study and were allocated into 2 groups; Training Group performed a 9-week RT program twice a week while the Control Group attended lectures on the disease.
- Conditions
- Parkinson Disease
- Being tested
- Resistance Training, Lectures on the disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingOther
The TG performed the RT program using weight machines. Before the training period, participants underwent three weeks with eight familiarization sessions to ensure proper technique execution. The protocol aimed to workout major muscle groups and involved the following exercises: chest press, knee extension, hamstrings curl, leg press, and seated row. Training sessions lasted approximately 50-60 minutes with 2 sets of 10-12 repetitions until fatigue.
Lectures on the diseaseOther
The control group attended an orientation program with lectures on health, quality of life and scientific update on disease.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | 9-week resistance training program Receives: Other: Resistance Training |
| Control group | Other | 'Lectures on the disease' Receives: Other: Lectures on the disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bradykinesia measured with Unified Parkinson's Disease Rating Scale, section III
Measured: One time point; after the end of 9-week resistance training
Functional Performance measured with Ten Meters Walk Test.
Measured: One time point; after the end of 9-week resistance training
Secondary outcomes (1)
Muscle strength measured with isokinetic peak torque.
Measured: One time point; after the end of 9-week resistance training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wagner Rodrigues Martins, University of Brasilia
- Investigators
- Ricardo Oliveira, PhD, Study director, College of Physical Education - University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447146
- Sponsor's protocol ID
- RT-PD
- Status last verified
- May 2015
- First submitted
- 12 May 2015
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dibble LE, Hale TF, Marcus RL, Droge J, Gerber JP, LaStayo PC. High-intensity resistance training amplifies muscle hypertrophy and functional gains in persons with Parkinson's disease. Mov Disord. 2006 Sep;21(9):1444-52. doi: 10.1002/mds.20997.
PubMed 16773643Falvo MJ, Sirevaag EJ, Rohrbaugh JW, Earhart GM. Resistance training induces supraspinal adaptations: evidence from movement-related cortical potentials. Eur J Appl Physiol. 2010 Jul;109(5):923-33. doi: 10.1007/s00421-010-1432-8. Epub 2010 Mar 21.
PubMed 20306270Fisher BE, Wu AD, Salem GJ, Song J, Lin CH, Yip J, Cen S, Gordon J, Jakowec M, Petzinger G. The effect of exercise training in improving motor performance and corticomotor excitability in people with early Parkinson's disease. Arch Phys Med Rehabil. 2008 Jul;89(7):1221-9. doi: 10.1016/j.apmr.2008.01.013. Epub 2008 Jun 13.
PubMed 18534554Allen NE, Canning CG, Sherrington C, Fung VS. Bradykinesia, muscle weakness and reduced muscle power in Parkinson's disease. Mov Disord. 2009 Jul 15;24(9):1344-51. doi: 10.1002/mds.22609.
PubMed 19425085
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Training on Bradykinesia and Physical Function in Patients With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT02447146
- Acronym / sponsor ID
- RT-PD
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 May 2015 (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 is a controlled trial to assess the effects of resistance training on bradykinesia and physical function in patients with Parkinson's Disease. Forty patients diagnosed with Parkinson Disease stage 1 to 3 of the Hoehn and Yahr scale took part in the study and were allocated into 2 groups; Training Group performed a 9-week RT program twice a week while the Control Group attended lectures on the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: Resistance Training9-week resistance training program |
| Control group | Other | Other: Lectures on the disease'Lectures on the disease' |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical neurologist confirmation of 1-3 Hoehn and Yahr stages,
- age between 50 and 80 years old;
- and physician attested to participate in the resistance training program.
Key exclusion criteria (2 listed)
- Diagnostic of any other neurological disease, cardiovascular disease, hematologic or orthopedic disorders;
- and motor fluctuations or severe dyskinesia that could affect their ability to perform the experimental 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 |
|---|---|---|
| Resistance TrainingThe TG performed the RT program using weight machines. Before the training period, participants underwent three weeks with eight familiarization sessions to ensure proper technique execution. The protocol aimed to workout major muscle groups and involved the following exercises: chest press, knee extension, hamstrings curl, leg press, and seated row. Training sessions lasted approximately 50-60 minutes with 2 sets of 10-12 repetitions until fatigue. | Other | Training group |
| Lectures on the diseaseThe control group attended an orientation program with lectures on health, quality of life and scientific update on disease. | Other | Control group |
Primary outcome
Bradykinesia measured with Unified Parkinson's Disease Rating Scale, section III
Time frame: One time point; after the end of 9-week resistance training
Functional Performance measured with Ten Meters Walk Test.
Time frame: One time point; after the end of 9-week resistance training
1 secondary outcome
Muscle strength measured with isokinetic peak torque.
Time frame: One time point; after the end of 9-week resistance training
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 18 May 2015.
- Background: PubMed 16773643Dibble LE, Hale TF, Marcus RL, Droge J, Gerber JP, LaStayo PC. High-intensity resistance training amplifies muscle hypertrophy and functional gains in persons with Parkinson's disease. Mov Disord. 2006 Sep;21(9):1444-52. doi: 10.1002/mds.20997.
- Background: PubMed 20306270Falvo MJ, Sirevaag EJ, Rohrbaugh JW, Earhart GM. Resistance training induces supraspinal adaptations: evidence from movement-related cortical potentials. Eur J Appl Physiol. 2010 Jul;109(5):923-33. doi: 10.1007/s00421-010-1432-8. Epub 2010 Mar 21.
- Background: PubMed 18534554Fisher BE, Wu AD, Salem GJ, Song J, Lin CH, Yip J, Cen S, Gordon J, Jakowec M, Petzinger G. The effect of exercise training in improving motor performance and corticomotor excitability in people with early Parkinson's disease. Arch Phys Med Rehabil. 2008 Jul;89(7):1221-9. doi: 10.1016/j.apmr.2008.01.013. Epub 2008 Jun 13.
- Results publication: PubMed 19425085Allen NE, Canning CG, Sherrington C, Fung VS. Bradykinesia, muscle weakness and reduced muscle power in Parkinson's disease. Mov Disord. 2009 Jul 15;24(9):1344-51. doi: 10.1002/mds.22609.
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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.
Ricardo Oliveira, PhD study director
College of Physical Education - University of Brasilia
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training and Lectures on the disease in people with Parkinson Disease, run by University of Brasilia.
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 2 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 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Bradykinesia measured with Unified Parkinson's Disease Rating Scale, section III (time frame: One time point; after the end of 9-week resistance training). The study lists 2 primary outcomes in all. 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 NCT02447146, which also lists 4 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 18 May 2015.