Safety and EffectivenessNCT04114318
The Role of Cycling-cognitive Dual-task Training in Early Parkinson's Disease
A study testing Dual-task cognitive-cycling training in people with Safety and Effectiveness, run by Chang Gung Memorial Hospital.
Trial summary
The purpose of the study will investigate the safety and effectiveness with eight-week cycling-cognitive dual-task training for early Parkinson's disease. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Safety and Effectiveness
- What is being tested?
- Dual-task cognitive-cycling training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 31 May 2017
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with Idiopathic Parkinson's disease (IPD)
- an age between 45 to 70 years
- asymmetrical onset of at least 2 of 3 cardinal sign
- Modified Hoehn and Yahr staging from 1 to 2.5 during off state
- Montreal cognitive assessment score of 26 or greater
- Exclusion Criteria: The patients were ineligible if they had
Show all 11Show fewer
- a neurological history other than Parkinson's disease
- ever undergone neurosurgery for Parkinson's disease
- had moderate to severe dyskinesia
- been unstable with medical or psychiatric co-morbidities, orthopedic conditions restricting exercise
- done more than 20 min of aerobic exercise over 3 sessions per week on their own
Who cannot join
None listed.
About this study
The purpose of the study will investigate the safety and effectiveness with eight-week cycling-cognitive dual-task training for early Parkinson's disease.
Read the detailed description
Background: Parkinson's disease is a neurodegenerative disorder of the basal ganglia in which the production of dopamine is reduced, leading to the motor and non-motor impairment and the loss of automaticity. Recently, the results across studies have indicated that motor-cognitive dual-task deficits in individuals with neurologic disorders appear to be amenable to training. Improvement of dual-task ability in individuals with neurologic disorders holds potential for improving gait, balance, and cognition. The most recent European guideline provides a more graded view, stating that in Hoehn and Yahr stages 2 and 3 dual-task training may be safe and effective. An overview of current ongoing randomized controlled trials focusing on dual-task rehabilitation, gait training or treadmill training was the major motor-task. However, cycling augmented by cognitive training has not been evaluated. In addition, antioxidant capacity is unclear for Parkinson's disease patients with long-term, regular cycling training.
Study purpose: The purpose of the study will investigate the safety and effectiveness with eight-week cycling-cognitive dual-task training for early Parkinson's disease. The antioxidant capacity will be assessed as well.
Methods: Parkinson's disease patients will be assigned to cycling training, cycling-cognitive dual task training, and following 8 weeks. All of the subjects will complete 3 assessments at pre-training, post-4 weeks, and post-8 weeks. The outcome measures are clinical severity and disability, performance of gait-cognitive and cycling-cognitive, cognitive-task performance, peripheral-blood oxidative stress, adverse events, etc.
Significance: In this study, evidence-based practice as the foundation, and perspective to design a safe and effective cycling-cognitive dual-task training for early Parkinson's disease. It can be verified in the clinical application of these experiments feasibility (practice-based evidence).
- Conditions
- Safety and Effectiveness
- Being tested
- Dual-task cognitive-cycling training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-task cognitive-cycling trainingOther
Also called Single-task cycling training
Cognitive and cycling training simultaneously for dual-task cognitive-cycling training; stationary bicycle exercise training for single-task cycling training
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Cycling | Experimental | Dual-task cognitive-cycling training; cognitive and cycling training simultaneously Receives: Other: Dual-task cognitive-cycling training |
| Cycling | Active comparator | Single-task cycling training; stationary bicycle exercise training Receives: Other: Dual-task cognitive-cycling training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's disease rating scale
There are 4 parts subscores: part 1 (0-16), part 2 (0-52), part 3 (0-96), part 4 (0-23). Total scale range 0-187 (summed part 1, 2, 3, 4), higher values represent a worse outcome.
Measured: 30 minutes
Gait speed in cm/second
using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
Measured: 5 minutes
Step length in cm
using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
Measured: 5 minutes
Step width in cm
using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
Measured: 5 minutes
Step time in second
using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
Measured: 5 minutes
Double limb support time in second
using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
Measured: 5 minutes
Modified Hoehn and Yahr staging
scale range 0-5. The scale was originally described in 1967 and included stages 1 through 5. It has since been modified with the addition of stages 1.5 and 2.5 to account for the intermediate course of Parkinson disease.
Measured: 5 minutes
Time up and go test in second
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility
Measured: 2 minutes
Secondary outcomes (3)
Cognitive performance
The cognitive performance was described as a composite score (%) = accuracy (%)/reaction time (ms) *100
Measured: 10 minutes
Dual-task interference
The effect of the dual-task was calculated as the difference between single-task and dual-task performance expressed as a percentage of single-task performance
Measured: 10 minutes
Adverse event
any complain from study subject
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Jun 2016
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and EffectivenessStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chin-Song Lu, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114318
- Sponsor's protocol ID
- 201600213A3
- Status last verified
- Aug 2019
- First submitted
- 26 Aug 2019
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after publishing, we will share IPD
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cycling-cognitive Dual-task Training in Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04114318
- Acronym / sponsor ID
- 201600213A3
- Conditions
- Safety and Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 3 Oct 2019 (actual)
- 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.
The purpose of the study will investigate the safety and effectiveness with eight-week cycling-cognitive dual-task training for early Parkinson's disease.
Detailed description
Background: Parkinson's disease is a neurodegenerative disorder of the basal ganglia in which the production of dopamine is reduced, leading to the motor and non-motor impairment and the loss of automaticity. Recently, the results across studies have indicated that motor-cognitive dual-task deficits in individuals with neurologic disorders appear to be amenable to training. Improvement of dual-task ability in individuals with neurologic disorders holds potential for improving gait, balance, and cognition. The most recent European guideline provides a more graded view, stating that in Hoehn and Yahr stages 2 and 3 dual-task training may be safe and effective. An overview of current ongoing randomized controlled trials focusing on dual-task rehabilitation, gait training or treadmill training was the major motor-task. However, cycling augmented by cognitive training has not been evaluated. In addition, antioxidant capacity is unclear for Parkinson's disease patients with long-term, regular cycling training.
Study purpose: The purpose of the study will investigate the safety and effectiveness with eight-week cycling-cognitive dual-task training for early Parkinson's disease. The antioxidant capacity will be assessed as well.
Methods: Parkinson's disease patients will be assigned to cycling training, cycling-cognitive dual task training, and following 8 weeks. All of the subjects will complete 3 assessments at pre-training, post-4 weeks, and post-8 weeks. The outcome measures are clinical severity and disability, performance of gait-cognitive and cycling-cognitive, cognitive-task performance, peripheral-blood oxidative stress, adverse events, etc.
Significance: In this study, evidence-based practice as the foundation, and perspective to design a safe and effective cycling-cognitive dual-task training for early Parkinson's disease. It can be verified in the clinical application of these experiments feasibility (practice-based evidence).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Cycling | Experimental | Other: Dual-task cognitive-cycling trainingDual-task cognitive-cycling training; cognitive and cycling training simultaneously |
| Cycling | Active comparator | Other: Dual-task cognitive-cycling trainingSingle-task cycling training; stationary bicycle exercise training |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- patients with Idiopathic Parkinson's disease (IPD)
- an age between 45 to 70 years
- asymmetrical onset of at least 2 of 3 cardinal sign
- Modified Hoehn and Yahr staging from 1 to 2.5 during off state
- Montreal cognitive assessment score of 26 or greater
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Dual-task cognitive-cycling trainingAlso: Single-task cycling trainingCognitive and cycling training simultaneously for dual-task cognitive-cycling training; stationary bicycle exercise training for single-task cycling training | Other | Cognitive-Cycling, Cycling |
Primary outcome
Unified Parkinson's disease rating scale
Time frame: 30 minutes
There are 4 parts subscores: part 1 (0-16), part 2 (0-52), part 3 (0-96), part 4 (0-23). Total scale range 0-187 (summed part 1, 2, 3, 4), higher values represent a worse outcome.
Gait speed in cm/second
Time frame: 5 minutes
using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
Step length in cm
Time frame: 5 minutes
using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
Step width in cm
Time frame: 5 minutes
using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
Step time in second
Time frame: 5 minutes
using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
Double limb support time in second
Time frame: 5 minutes
using GAITRite with a 3.66-meter long and 0.9-meter wide instrumented walkway
Modified Hoehn and Yahr staging
Time frame: 5 minutes
scale range 0-5. The scale was originally described in 1967 and included stages 1 through 5. It has since been modified with the addition of stages 1.5 and 2.5 to account for the intermediate course of Parkinson disease.
Time up and go test in second
Time frame: 2 minutes
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility
3 secondary outcomes
Cognitive performance
Time frame: 10 minutes
Dual-task interference
Time frame: 10 minutes
Adverse event
Time frame: 5 minutes
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 3 Oct 2019.
- Individual participant dataSharing planned: No. after publishing, we will share IPD
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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.
Chin-Song Lu, MD principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Dual-task cognitive-cycling training in people with Safety and Effectiveness, run by Chang Gung Memorial Hospital.
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 11 inclusion and 0 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 3 Oct 2019. 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?
Unified Parkinson's disease rating scale (time frame: 30 minutes). The study lists 8 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 3 Oct 2019.