Parkinson Disease(PD)NCT01971528
Central and Peripheral Fatigue in Individuals With Parkinson's Disease - Evaluation and Training
A study testing Electronic muscle stimulator and Muscle strength training in people with Parkinson Disease(PD), run by Chang Gung University at 1 site in Taiwan.
Trial summary
Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD). Past research indicated that more than half of the individuals with PD demonstrated fatigue symptom. The severity of fatigue was also correlated to the quality of life in individuals with PD. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease(PD)
- What is being tested?
- Electronic muscle stimulator and Muscle strength training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Dec 2012to 10 May 2015
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson disease.
Who cannot join
- Musculoskeletal injuries for knee.
- Osteoporosis.
- Diabetes.
- PD subjects:
- Musculoskeletal injuries for knee.
- Osteoporosis.
- Diabetes.
- Any peripheral or central nervous system injury or disease patients.
Trial locations and contacts
1 site in 1 country.
About this study
Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD). Past research indicated that more than half of the individuals with PD demonstrated fatigue symptom. The severity of fatigue was also correlated to the quality of life in individuals with PD. Finding the contributions of the central and the peripheral factors to fatigue and developing an effective training program for individuals with PD are very important.
Fatigue can be categorized into peripheral or central causes. The central fatigue and voluntary activation failure originate from the decrease in motivation or the reduction of the conduction within corticospinal tracts. Long term activation failure and central fatigue will cause disuse of muscle and result in peripheral weakness and peripheral fatigue. Quantifying the weighting of central versus peripheral factors contributing to the fatigue in people with PD is important.
Read more
Most of the conventional strength and endurance training programs were based on the researches of young groups. Almost no training program was design for enhancing the voluntary activation level and relief the central fatigue. Seeking an appropriate training program to enhance central activation is very important for individuals with PD who prone to fatigue.
Previous studies have shown that increasing afferent input by peripheral electrical stimulation (ES) at sensory threshold enhanced the plasticity of contralateral primary sensory cortex, the excitability of corticospinal tracts, and the functional performance in young adults. Combining afferent input with strength training was more effective than strength training along. ES, which is easy to quantify the dose of afferent input, is a feasible method to provide such training.
The purpose of this project is to investigate the effects of the combination of ES at sensory threshold and strength training on voluntary activation in the individuals with PD.
- Conditions
- Parkinson Disease(PD)
- Being tested
- Electronic muscle stimulator, Muscle strength training
- Keywords
- Muscle strength, fatigue, electromyography (EMG), central fatigue, strength straining
- 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.
Electronic muscle stimulatorDevice
Participants will perform 8 weeks of electrical stimulation for Quadriceps muscle belly(30 minutes/time, 3 times/week).
Muscle strength trainingOther
Participants will perform 8 weeks of isotonic contraction muscle strength training for lower extremities.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: Health control | No intervention | pilot study: Establishing the central and peripheral contributing factors to the voluntary muscle strength loss during a fatiguing exercise in young and PD groups. |
| Stage 1: PD subjects | No intervention | pilot study: Establishing the central and peripheral contributing factors to the voluntary muscle strength loss during a fatiguing exercise in young and PD groups. |
| Stage 2: Health subjects | No intervention | pilot study: Finding optimal sensory stimulation parameters for PD individuals. |
| Stage 2: PD subjects | No intervention | pilot study: Finding optimal sensory stimulation parameters for PD individuals. |
| Stage 3: PD subjects | Experimental | Investigating the long-term effects of combined sensory stimulating strengthening program on the activation level and central fatigue in PD individuals. Receives: Device: Electronic muscle stimulator; Other: Muscle strength training |
| Stage 3: PD subjects (Control Subjects) | No intervention | Investigating the long-term effects of combined sensory stimulating strengthening program on the activation level and central fatigue in PD individuals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle twitch force
Measure of changes in muscle twitch force by interpolation twitch technique.
Measured: baseline, 8 weeks.
Muscle voluntary activity level
Measure of changes in muscle voluntary activity level by interpolation twitch technique.
Measured: Baseline,8 weeks
Muscle strength test for lower extremities.
Measure of changes in muscle strength test by clinical test.
Measured: Baseline, 8 weeks
The central activation and the excitability of motor cortex
Measure of changes in the central activation and the excitability of motor cortex by Transcranial magnetic stimulation.
Measured: Baseline,8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study start18 Dec 2012
- Primary completion11 Sep 2014
- Study completion10 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease(PD)Studies 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
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Ju Chang, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971528
- Sponsor's protocol ID
- 100-3167A3
- Status last verified
- Mar 2024
- First submitted
- 18 Oct 2013
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central and Peripheral Fatigue in Individuals With Parkinson's Disease - Evaluation and Training
- ClinicalTrials.gov ID
- NCT01971528
- Acronym / sponsor ID
- 100-3167A3
- Conditions
- Parkinson Disease(PD)
- Keywords
- Muscle strength, fatigue, electromyography (EMG), central fatigue, strength straining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 18 Dec 2012 (actual)
- Primary completion
- 11 Sep 2014 (actual)
- Study completion
- 10 May 2015 (actual)
- First posted
- 29 Oct 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.
Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD). Past research indicated that more than half of the individuals with PD demonstrated fatigue symptom. The severity of fatigue was also correlated to the quality of life in individuals with PD. Finding the contributions of the central and the peripheral factors to fatigue and developing an effective training program for individuals with PD are very important.
Fatigue can be categorized into peripheral or central causes. The central fatigue and voluntary activation failure originate from the decrease in motivation or the reduction of the conduction within corticospinal tracts. Long term activation failure and central fatigue will cause disuse of muscle and result in peripheral weakness and peripheral fatigue. Quantifying the weighting of central versus peripheral factors contributing to the fatigue in people with PD is important.
Most of the conventional strength and endurance training programs were based on the researches of young groups. Almost no training program was design for enhancing the voluntary activation level and relief the central fatigue. Seeking an appropriate training program to enhance central activation is very important for individuals with PD who prone to fatigue.
Previous studies have shown that increasing afferent input by peripheral electrical stimulation (ES) at sensory threshold enhanced the plasticity of contralateral primary sensory cortex, the excitability of corticospinal tracts, and the functional performance in young adults. Combining afferent input with strength training was more effective than strength training along. ES, which is easy to quantify the dose of afferent input, is a feasible method to provide such training.
The purpose of this project is to investigate the effects of the combination of ES at sensory threshold and strength training on voluntary activation in the individuals with PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Stage 1: Health control | No intervention | –pilot study: Establishing the central and peripheral contributing factors to the voluntary muscle strength loss during a fatiguing exercise in young and PD groups. |
| Stage 1: PD subjects | No intervention | –pilot study: Establishing the central and peripheral contributing factors to the voluntary muscle strength loss during a fatiguing exercise in young and PD groups. |
| Stage 2: Health subjects | No intervention | –pilot study: Finding optimal sensory stimulation parameters for PD individuals. |
| Stage 2: PD subjects | No intervention | –pilot study: Finding optimal sensory stimulation parameters for PD individuals. |
| Stage 3: PD subjects | Experimental | Device: Electronic muscle stimulator, Other: Muscle strength trainingInvestigating the long-term effects of combined sensory stimulating strengthening program on the activation level and central fatigue in PD individuals. |
| Stage 3: PD subjects (Control Subjects) | No intervention | –Investigating the long-term effects of combined sensory stimulating strengthening program on the activation level and central fatigue in PD individuals. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Parkinson disease.
Key exclusion criteria (8 listed)
- Musculoskeletal injuries for knee.
- Osteoporosis.
- Diabetes.
- Musculoskeletal injuries for knee.
- Osteoporosis.
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 |
|---|---|---|
| Electronic muscle stimulatorParticipants will perform 8 weeks of electrical stimulation for Quadriceps muscle belly(30 minutes/time, 3 times/week). | Device | Stage 3: PD subjects |
| Muscle strength trainingParticipants will perform 8 weeks of isotonic contraction muscle strength training for lower extremities. | Other | Stage 3: PD subjects |
Primary outcome
Muscle twitch force
Time frame: baseline, 8 weeks.
Measure of changes in muscle twitch force by interpolation twitch technique.
Muscle voluntary activity level
Time frame: Baseline,8 weeks
Measure of changes in muscle voluntary activity level by interpolation twitch technique.
Muscle strength test for lower extremities.
Time frame: Baseline, 8 weeks
Measure of changes in muscle strength test by clinical test.
The central activation and the excitability of motor cortex
Time frame: Baseline,8 weeks
Measure of changes in the central activation and the excitability of motor cortex by Transcranial magnetic stimulation.
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 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic muscle stimulator and Muscle strength training in people with Parkinson Disease(PD), run by Chang Gung University at 1 site in Taiwan.
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 1 inclusion and 8 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 Mar 2024. 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 Taiwan. 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?
Muscle twitch force (time frame: baseline, 8 weeks.). The study lists 4 primary outcomes in all. 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 Mar 2024.