Parkinson's DiseaseNCT04651140
Research on the Effect and Mechanism of Aerobic Exercise on PD
A study testing aerobic exercise in people with Parkinson's Disease and Physical Exercise, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
This trial is expected to recruit patients with primary Parkinson's disease and give them four consecutive weeks of aerobic exercise to observe its effect on Parkinson's disease and explore its mechanism Read more about this study
- Who is it for?
- Ages 55 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Physical Exercise
- What is being tested?
- aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2020to 30 Oct 2021
- 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 55 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants were diagnosed primary PD according to the 2015 MDS diagnostic criteria
- Participants are between 55 and 65 years old
Who cannot join
- Severe heart
- liver dysfunction
- kidney dysfunction
- severe cognitive dysfunction
- severe anxiety and depression
- history of mental illness
Show all 10Show fewer
- history of cerebral infarction or ischemic attack in the past three months
- acute myocardial infarction or acute coronary in the past three months
- Parkinson's Pulse syndrome
- medication history (drugs that improve blood circulation in the brain and increase the excitability of the nervous system)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research on the Effect and Mechanism of Aerobic Exercise on Parkinson's
This trial is expected to recruit patients with primary Parkinson's disease and give them four consecutive weeks of aerobic exercise to observe its effect on Parkinson's disease and explore its mechanism
Read the detailed description
This trial is expected to recruit patients with primary Parkinson's disease who are distributed into tremor group and stiff group and give them the same kind of four consecutive weeks of aerobic exercise to observe its effect on Parkinson's disease and explore its mechanism
- Conditions
- Parkinson's Disease, Physical Exercise
- Being tested
- aerobic exercise
- Keywords
- Parkinson's Disease, Physical exercise, Mechanism
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseBehavioural
Participants ride an Acon-8650 model exercise bicycle 3 times a week for 1 hour each time for four consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| Tremor group | Active comparator | Participants in the tremor group have tremor as the main clinical manifestation Receives: Behavioral: aerobic exercise |
| Stiff group | Active comparator | Participants in the tremor group have stiff as the main clinical manifestation Receives: Behavioral: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Disorder Society-United Parkinson's Disease Rating Scale (MDS-UPDRS)
to assess the motor and nonmotor function of PD,0-200 scores,the higher scores mean lower function
Measured: changes of MDS-UPDRS score from baseline at four weeks
Montreal Cognitive Assessing(MoCA) score
to assess the cognitive function of PD,0-30 scores,the higher scores mean better function
Measured: changes of MoCA score from baseline at four weeks
The Epworth Sleeping Scale(ESS)
to assess the degree of drowsiness, 0-24 scores, the higher scores mean severe drowsiness
Measured: changes of ESS score from baseline at four weeks
Non-Motor Symptom Scale (NMSS)
to assess the non-motor of PD , 0-120 scores, the higher scores mean severe non-motor damage
Measured: changes of NMSS score from baseline at four weeks
Secondary outcomes (4)
cerebral blood variation by Head MRI
to assess the cerebral blood variation by head MRI
Measured: changes of the cerebral blood from baseline at four weeks
cerebral blood flow velocity
cerebral blood flow velocity is recorded using transcranial Doppler and a servo-controlled plethysmograph respectively.
Measured: changes of the cerebral blood flow velocity from baseline at four weeks
the level of arterial blood pressure
arterial blood pressure is recorded using transcranial Doppler and a servo-controlled plethysmograph respectively. Both systolic and diastolic pressures will be assessed during the study period.
Measured: changes of the arterial blood pressure from baseline at four weeks
the concentration of microRNA in peripheral blood by gene chip
to test the the concentration of microRNA in peripheral blood
Measured: changes of microRNA from baseline at four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start13 Oct 2020
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Ying, The First Hospital of Jilin University
- Investigators
- Ying Zhang, Doctor, Study director, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651140
- Sponsor's protocol ID
- Zhang Ying
- Status last verified
- Nov 2020
- First submitted
- 8 Nov 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Effect and Mechanism of Aerobic Exercise on Parkinson's
- ClinicalTrials.gov ID
- NCT04651140
- Acronym / sponsor ID
- Zhang Ying
- Conditions
- Parkinson's Disease, Physical Exercise
- Keywords
- Parkinson's Disease, Physical exercise, Mechanism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 3 Dec 2020 (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.
This trial is expected to recruit patients with primary Parkinson's disease and give them four consecutive weeks of aerobic exercise to observe its effect on Parkinson's disease and explore its mechanism
Detailed description
This trial is expected to recruit patients with primary Parkinson's disease who are distributed into tremor group and stiff group and give them the same kind of four consecutive weeks of aerobic exercise to observe its effect on Parkinson's disease and explore its mechanism
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tremor group | Active comparator | Behavioral: aerobic exerciseParticipants in the tremor group have tremor as the main clinical manifestation |
| Stiff group | Active comparator | Behavioral: aerobic exerciseParticipants in the tremor group have stiff as the main clinical manifestation |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants were diagnosed primary PD according to the 2015 MDS diagnostic criteria
- Participants are between 55 and 65 years old
Key exclusion criteria (10 listed)
- Severe heart
- liver dysfunction
- kidney dysfunction
- severe cognitive dysfunction
- severe anxiety and depression
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 |
|---|---|---|
| aerobic exerciseParticipants ride an Acon-8650 model exercise bicycle 3 times a week for 1 hour each time for four consecutive weeks | Behavioural | Stiff group, Tremor group |
Primary outcome
Movement Disorder Society-United Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: changes of MDS-UPDRS score from baseline at four weeks
to assess the motor and nonmotor function of PD,0-200 scores,the higher scores mean lower function
Montreal Cognitive Assessing(MoCA) score
Time frame: changes of MoCA score from baseline at four weeks
to assess the cognitive function of PD,0-30 scores,the higher scores mean better function
The Epworth Sleeping Scale(ESS)
Time frame: changes of ESS score from baseline at four weeks
to assess the degree of drowsiness, 0-24 scores, the higher scores mean severe drowsiness
Non-Motor Symptom Scale (NMSS)
Time frame: changes of NMSS score from baseline at four weeks
to assess the non-motor of PD , 0-120 scores, the higher scores mean severe non-motor damage
4 secondary outcomes
cerebral blood variation by Head MRI
Time frame: changes of the cerebral blood from baseline at four weeks
cerebral blood flow velocity
Time frame: changes of the cerebral blood flow velocity from baseline at four weeks
the level of arterial blood pressure
Time frame: changes of the arterial blood pressure from baseline at four weeks
the concentration of microRNA in peripheral blood by gene chip
Time frame: changes of microRNA from baseline at four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Ying Zhang, Doctor study director
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise in people with Parkinson's Disease and Physical Exercise, run by The First Hospital of Jilin University at 1 site in China.
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 10 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 5 Jan 2021. 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 China. 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?
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?
Movement Disorder Society-United Parkinson's Disease Rating Scale (MDS-UPDRS) (time frame: changes of MDS-UPDRS score from baseline at four 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 5 Jan 2021.