Back to resultsEffect of Physical Rehabilitation in Patients With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rehabilitation
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease focused on measuring "Parkinson Disease", "cognitive function", "postural balance", "physical rehabilitation"
Eligibility Criteria
Inclusion Criteria: Diagnosed with Parkinson's disease according to the Movement Disorder Society (MDS) 2015 criteria. Mild to moderate stage according to the Hoehn and Yahr scale. No hearing or visual impairments that could hinder the integration and implementation of the rehabilitation protocol. Has the ability to communicate and walk. Patient has been stable on treatment for 3 months. Exclusion Criteria: A contraindication to engaging in cardiovascular physical activity A Montreal Cognitive Assessment score (MoCA ) of less than 24. A current psychiatric disorder that could make it difficult or dangerous to adhere to the research protocol. Musculoskeletal impairments or excessive pain in any joint that could limit participation in an exercise program. Treatment with sedative medications
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control group
experimental group
Arm Description
The control group will be invited to attend the program three times per week and will engage in an endurance training program
the experimental group will be invited to attend the program three times per week and will participate in a combined endurance training and cognitive training program.
Outcomes
Primary Outcome Measures
Cardiorespiratory Parameters
Cardiorespiratory Parameters will be assessed using the six-minute walk test (6MWT).
Postural Balance
Postural balance will be assessed using the Timed Up and Go test (TUG) and stabilometry platform
Depression
The depression variable will be assessed through Beck Depression Inventory-II .
Cognitive Function
Cognitive function will be evaluated using the Montreal Cognitive Assessment score (MoCA) .
Secondary Outcome Measures
Strength
handgrip test, Functional Reach Test, Five time to sit and stand test
Full Information
NCT ID
NCT06021834
First Posted
May 30, 2023
Last Updated
August 28, 2023
Sponsor
Faculty of Medicine, Sousse
1. Study Identification
Unique Protocol Identification Number
NCT06021834
Brief Title
Effect of Physical Rehabilitation in Patients With Parkinson's Disease
Official Title
Effect of Physical Rehabilitation on Cardiorespiratory Parameters, Postural Balance and Sociopsychological and Cognitive Variables in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 8, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty of Medicine, Sousse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective study. The aim of this study is to investigate the effect of exercise retraining on cardiorespiratory parameters, postural balance, sociopsychological variables, and cognitive function in subjects with Parkinson's disease.
There will be two measurement sessions, one pre-intervention and one post-intervention (measuring cardiorespiratory parameters, evaluating dynamic and static postural balance, and assessing cognitive function).
Detailed Description
this is a 12-week prospective study with the theme that I wish to develop in this context entitled "the effect of exercise retraining on cardiorespiratory parameters, postural balance, sociopsychological variables, and cognitive function in subjects with Parkinson's disease".
There will be two measurement sessions, one pre-intervention and one post-intervention (measuring cardiorespiratory parameters, evaluating dynamic and static postural balance, and assessing cognitive function).
The recruited subjects will be randomly assigned to two groups: a control group and an experimental group. The subjects will be invited to attend the program three times per week.
The control group will engage in an endurance training program, while the experimental group will participate in a combined endurance training and cognitive training program
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
"Parkinson Disease", "cognitive function", "postural balance", "physical rehabilitation"
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Description
The control group will be invited to attend the program three times per week and will engage in an endurance training program
Arm Title
experimental group
Arm Type
Experimental
Arm Description
the experimental group will be invited to attend the program three times per week and will participate in a combined endurance training and cognitive training program.
Intervention Type
Other
Intervention Name(s)
rehabilitation
Intervention Description
The subjects will be invited to attend the program three times per week.
Primary Outcome Measure Information:
Title
Cardiorespiratory Parameters
Description
Cardiorespiratory Parameters will be assessed using the six-minute walk test (6MWT).
Time Frame
There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)
Title
Postural Balance
Description
Postural balance will be assessed using the Timed Up and Go test (TUG) and stabilometry platform
Time Frame
There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)
Title
Depression
Description
The depression variable will be assessed through Beck Depression Inventory-II .
Time Frame
There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)
Title
Cognitive Function
Description
Cognitive function will be evaluated using the Montreal Cognitive Assessment score (MoCA) .
Time Frame
There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)
Secondary Outcome Measure Information:
Title
Strength
Description
handgrip test, Functional Reach Test, Five time to sit and stand test
Time Frame
There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with Parkinson's disease according to the Movement Disorder Society (MDS) 2015 criteria.
Mild to moderate stage according to the Hoehn and Yahr scale.
No hearing or visual impairments that could hinder the integration and implementation of the rehabilitation protocol.
Has the ability to communicate and walk.
Patient has been stable on treatment for 3 months.
Exclusion Criteria:
A contraindication to engaging in cardiovascular physical activity
A Montreal Cognitive Assessment score (MoCA ) of less than 24.
A current psychiatric disorder that could make it difficult or dangerous to adhere to the research protocol.
Musculoskeletal impairments or excessive pain in any joint that could limit participation in an exercise program.
Treatment with sedative medications
12. IPD Sharing Statement
Learn more about this trial
Effect of Physical Rehabilitation in Patients With Parkinson's Disease
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