Parkinson's Disease (PD)NCT02017938
Establishing the Central and Peripheral Fatigue Indexes and VR Based Anti-fatigue Training Paradigm for Individuals With Parkinson Disease
A study testing Virtual Reality anti-fatigue ergo cycling training (Self-made) in people with Parkinson's 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 researches 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 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- Virtual Reality anti-fatigue ergo cycling training (Self-made)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Dec 2014to 31 Jul 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson disease
- Hoehn and Yahr ≦3
Who cannot join
- Musculoskeletal injuries
- 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 researches 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, building reliable fatigue indexes, and developing an effective training program for individuals with PD are very important.
The purpose of this project is to develop non-invasive method to monitor central and peripheral fatigue, to establish Virtual Reality(VR) anti-fatigue ergo cycling training paradigm, and to evaluate the long term training effect in individuals with PD.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- Virtual Reality anti-fatigue ergo cycling training (Self-made)
- Keywords
- Fatigue, electromyography (EMG), central fatigue, cycling training
- 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 Reality anti-fatigue ergo cycling training (Self-made)Procedure or surgery
To establish a Virtual Reality systems to reduce fatigue of cycling training for PD subjects.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: Health group | No intervention | To establish non-invasive fatigue monitoring method via testing healthy individuals. |
| Stage 2: PD group | Experimental | To find the optimal feedback variables for anti-fatigue training on individuals with PD. Receives: Procedure: Virtual Reality anti-fatigue ergo cycling training (Self-made) |
| Stage 2: Health group | Experimental | Stage 2 controlled group Receives: Procedure: Virtual Reality anti-fatigue ergo cycling training (Self-made) |
| Stage 3: PD group | Experimental | To evaluate the effect of four weeks of VR anti-fatigue ergo cycling training on various fatigue components and functional abilities in individuals with PD. Receives: Procedure: Virtual Reality anti-fatigue ergo cycling training (Self-made) |
| Stage 3: PD controlled group | No intervention | Stage 3 controlled group |
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, 1 week
Muscle voluntary activity level
Measure of changes in muscle voluntary activity level by interpolation twitch technique.
Measured: Baseline,1 week
Heart rate/Heart rate variability
Measure of changes in Heart rate/Heart rate variability.
Measured: Baseline,1 week
Borg's rate of perceived exertion
Measure of changes in Borg's rate of perceived exertion.
Measured: Baseline,1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study start10 Dec 2014
- Primary completion30 Jul 2015
- Study completion31 Jul 2016
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 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
- 31 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
- NCT02017938
- Sponsor's protocol ID
- 101-5141B
- Status last verified
- Mar 2024
- First submitted
- 17 Dec 2013
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
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 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Central and Peripheral Fatigue Indexes and VR Based Anti-fatigue Training Paradigm for Individuals With Parkinson Disease
- ClinicalTrials.gov ID
- NCT02017938
- Acronym / sponsor ID
- 101-5141B
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Fatigue, electromyography (EMG), central fatigue, cycling training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 10 Dec 2014 (actual)
- Primary completion
- 30 Jul 2015 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 23 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.
Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD). Past researches 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, building reliable fatigue indexes, and developing an effective training program for individuals with PD are very important.
The purpose of this project is to develop non-invasive method to monitor central and peripheral fatigue, to establish Virtual Reality(VR) anti-fatigue ergo cycling training paradigm, and to evaluate the long term training effect in individuals with PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Stage 1: Health group | No intervention | –To establish non-invasive fatigue monitoring method via testing healthy individuals. |
| Stage 2: PD group | Experimental | Procedure: Virtual Reality anti-fatigue ergo cycling training (Self-made)To find the optimal feedback variables for anti-fatigue training on individuals with PD. |
| Stage 2: Health group | Experimental | Procedure: Virtual Reality anti-fatigue ergo cycling training (Self-made)Stage 2 controlled group |
| Stage 3: PD group | Experimental | Procedure: Virtual Reality anti-fatigue ergo cycling training (Self-made)To evaluate the effect of four weeks of VR anti-fatigue ergo cycling training on various fatigue components and functional abilities in individuals with PD. |
| Stage 3: PD controlled group | No intervention | –Stage 3 controlled group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Parkinson disease
- Hoehn and Yahr ≦3
Key exclusion criteria (4 listed)
- Musculoskeletal injuries
- Osteoporosis
- Diabetes
- Any peripheral or central nervous system injury or disease patients
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 Reality anti-fatigue ergo cycling training (Self-made)To establish a Virtual Reality systems to reduce fatigue of cycling training for PD subjects. | Procedure or surgery | Stage 2: Health group, Stage 2: PD group, Stage 3: PD group |
Primary outcome
Muscle twitch force
Time frame: baseline, 1 week
Measure of changes in muscle twitch force by interpolation twitch technique.
Muscle voluntary activity level
Time frame: Baseline,1 week
Measure of changes in muscle voluntary activity level by interpolation twitch technique.
Heart rate/Heart rate variability
Time frame: Baseline,1 week
Measure of changes in Heart rate/Heart rate variability.
Borg's rate of perceived exertion
Time frame: Baseline,1 week
Measure of changes in Borg's rate of perceived exertion.
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 Apr 2024.
- 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.
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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 Virtual Reality anti-fatigue ergo cycling training (Self-made) in people with Parkinson's 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 2 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 Apr 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, 1 week). 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?
On the ClinicalTrials.gov record for NCT02017938, 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 1 Apr 2024.