NCT04651140

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

January 5, 2021

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

November 8, 2020

Last Update Submit

December 30, 2020

Conditions

Parkinson's DiseasePhysical Exercise

Keywords

Parkinson's DiseasePhysical exerciseMechanism

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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

    changes of NMSS score from baseline at four weeks

Secondary Outcomes (4)

  • cerebral blood variation by Head MRI

    changes of the cerebral blood from baseline at four weeks

  • cerebral blood flow velocity

    changes of the cerebral blood flow velocity from baseline at four weeks

  • the level of arterial blood pressure

    changes of the arterial blood pressure from baseline at four weeks

  • the concentration of microRNA in peripheral blood by gene chip

    changes of microRNA from baseline at four weeks

Study Arms (2)

Tremor group

ACTIVE COMPARATOR

Participants in the tremor group have tremor as the main clinical manifestation

Behavioral: aerobic exercise

Stiff group

ACTIVE COMPARATOR

Participants in the tremor group have stiff as the main clinical manifestation

Behavioral: aerobic exercise

Interventions

aerobic exerciseBEHAVIORAL

Participants ride an Acon-8650 model exercise bicycle 3 times a week for 1 hour each time for four consecutive weeks

Stiff groupTremor group

Eligibility Criteria

Age55 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants were diagnosed primary PD according to the 2015 MDS diagnostic criteria
  • Participants are between 55 and 65 years old

You may not qualify if:

  • Severe heart
  • liver dysfunction
  • kidney dysfunction
  • severe cognitive dysfunction
  • severe anxiety and depression
  • history of mental illness
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FirstJilinU

Changchun, 130021, China

Location

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ying Zhang, Doctor

    The First Hospital of Jilin University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2020

First Posted

December 3, 2020

Study Start

October 13, 2020

Primary Completion

October 30, 2021

Study Completion

October 30, 2021

Last Updated

January 5, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)