Investigating and Comparing the Effect of Moderate-Intensity Aerobic Exercises on Implicit Learning, Recall, and Skill Transfer of Upper Limbs in Parkinson's Patients with Freezing of Gait
Design
Twenty-eight Parkinson's patients with freezing of gait symptoms were randomly assigned in a no-blind manner to either intervention or control groups.
Settings and conduct
hospitals and clinics across Tehran will be investigated.
Participants/Inclusion and exclusion criteria
✔ Age between 30 and 75 years
✔ Diagnosis of idiopathic Parkinson’s disease
✔ Disease stage 1–4 according to the Hoehn & Yahr scale
✔ Adequate cognitive status with a score above 24 on the MoCA test
✔ No history of addiction or diabetes
✔ No other neurological disorders
✔ No untreated orthopedic conditions
✔ Presence of Freezing of Gait (FOG)
Exclusion Criteria:
✔ Individuals whose medication regimen changes during the study
✔ Development of disabling comorbid conditions during the study
✔ Presence of cardiovascular or respiratory problems
Intervention groups
Intervention Group:
In the acquisition phase, before performing the simulated eating task, participants perform 30 minutes of moderate-intensity aerobic exercise (60–70% of maximum heart rate) on an ergometer. After 10 minutes of rest, the simulated eating task is performed.
Control Group:
This group rests in a seated position for a duration equal to the aerobic exercise time of the intervention group and enters the simulated eating task practice phase without performing aerobic exercise.
Main outcome variables
Upper limb skill learning
Retention
Transfer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160822029471N2
Registration date:2025-09-07, 1404/06/16
Registration timing:prospective
Last update:2025-09-07, 1404/06/16
Update count:0
Registration date
2025-09-07, 1404/06/16
Registrant information
Name
mohammadtaghi joghataei
Name of organization / entity
professor
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4569
Email address
joghataei@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-11, 1404/06/20
Expected recruitment end date
2025-10-22, 1404/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Aerobic Exercise on Implicit Learning, Retention, and Transfer of Upper Extremity Motor Skills in Parkinson’s Patients with Freezing of Gait
Public title
Effect of Aerobic Exercise on Implicit Learning in Parkinson’s Patients with Freezing of Gait
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Parkinson's disease patients in Hohne and Yahr stage 1-4
intact cognitive function (i.e., score ≥24 on the Montreal Cognitive Assessment (MoCA))
Exclusion criteria:
cardiovascular and pulmonary problems
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
After the initial assessments, patients with Parkinson's disease who have freezing of gait will be randomly allocated using a block randomization method (with concealed allocation via sealed opaque envelopes) in a 1:1 ratio into two groups:
The group receiving aerobic exercise prior to motor training, and
The group that does not receive aerobic exercise before motor training.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-03-11, 1401/12/20
Ethics committee reference number
IR.IUMS.REC.1401.1004
Health conditions studied
1
Description of health condition studied
Parkinson' s disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Implicit learning, retention and transfer
Timepoint
قبل از مداخله - بعد از مداخله
Method of measurement
time
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group, prior to the motor learning sessions (three consecutive sessions), perform a total of three sessions of moderate-intensity aerobic exercise. The exercises are carried out on a stationary bicycle for 30 minutes. Exercise intensity is adjusted so that participants pedal at a rate of 50 to 70 revolutions per minute, corresponding to 70% of their maximum heart rate.
Category
Rehabilitation
2
Description
Control group: Patients in this group do not perform any aerobic exercise and remain at rest during this period.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasol akram Hospital
Full name of responsible person
Amir hosseyn Habibi
Street address
Rasoul-e Akram Hospital, Maziar Mansouri Street, Sattar khan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
rasoolhospital@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Majid Safa
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2703
Email
safa.m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Taghi Joghataie
Position
Professor in Anatomy
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
009821867045696
Email
joghataei@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Taghi Joghatai
Position
Professor in Anatomy
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
009821867045696
Email
joghataei@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naeeme Haji Alizadeh
Position
PhD candidate in Neurosciences
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 7760 2886
Email
alizadeot@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as information related to the primary outcome or similar, can be shared.
When the data will become available and for how long
Access period begins 6 months after publication of the results.
To whom data/document is available
Data will be available to researchers affiliated with academic and scientific institutions.
Under which criteria data/document could be used
Data inspection is permitted provided proper citation is given.
From where data/document is obtainable
Dr. Mohammad Tagh Joghataei
joghataei@iums.ac.ir
What processes are involved for a request to access data/document
Data are available for inspection by qualified researchers upon request, subject to appropriate citation and ethical considerations.