- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07302386
Exercise Management in Parkinson's Disease
The Effects of Exercise Management in Parkinson's Disease
The aim of this study is to examine the benefits that individuals with Parkinson's disease will gain from the rehabilitation program by enabling them to manage their exercise times independently using telerehabilitation method.
The main research questions examined in this study are as follows:
- Are the improvements in quality of life, walking speed and changes in functionality parameters achieved by individuals with Parkinson's disease through managing their own exercise plans as effective as those achieved through a supervised exercise programme?
- Is it effective for Parkinson's patients to manage their own exercise plans in improving their adherence to exercise?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Parkinson's Disease (PD) is a movement disorder characterized by motor and non-motor symptoms, changes in the patient's balance and gait patterns, and a significant impact on daily living activities. Physical therapy and rehabilitation play a crucial role in managing the symptoms resulting from PD. It is known that early participation in a rehabilitation program significantly improves patients' quality of life.
Patients need to incorporate exercise prescriptions designed specifically for them into their lives and participate in a lifelong exercise program. While integrating these exercises into their lives, patients encounter certain barriers and lose their motivation to exercise. These barriers can include transportation, economic problems, time management, and motor and non-motor symptoms.
Home-based exercises and telerehabilitation methods emerge as solutions for dealing with transportation, economic problems, and time management. These methods can be seen as important aids in helping patients develop the habit of exercising.
Patients diagnosed with Idiopathic Parkinson's Disease who meet the inclusion criteria and agree to participate in the study will be included. The demographic information (age, occupation, height, body weight, etc.) and clinical status (duration of diagnosis, medication dosage, etc.) of all participants will be recorded. The Montreal Cognitive Assessment Scale will be used to determine the cognitive level of patients. The motor assessment of patients will be performed using the Cognitive Parkinson's Disease Assessment Scale III. The Montreal Cognitive Assessment Scale will be used to determine the cognitive level of patients. Functional balance and mobility will be assessed using the Timed Up and Go Test and the 10-meter Walk Test. Repetitive movement performance will be assessed using the 5 Repeat Sit-to-Stand Test, and balance level will be assessed using the Activity-Specific Balance Confidence Scale. Quality of life will be assessed using the Parkinson's Disease Quality of Life Questionnaire. Motivation to exercise and self-assessment will be determined using the Behavioral Modifications to Exercise Scale-2. These assessment criteria will be re-evaluated before and after the exercise program. Patients will be given an exercise diary and asked to keep it throughout the program. The System Usability Scale will be used to evaluate the usability of the website developed for this thesis study.
Participants will be randomly assigned to 2 groups. The control group will complete the exercise program assigned to them continuously via the web-based system. The experimental group will complete the exercise program assigned to them at their preferred time within the same day. Exercise programs will be planned for 8 weeks.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gökçe Kartal
- Phone Number: +905055624837
- Email: gokcekrtl2@gmail.com
Study Locations
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Istanbul
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Maltepe, Istanbul, Turkey (Türkiye), 34852
- Recruiting
- Marmara University
-
Contact:
- Gökçe Kartal
- Phone Number: 05055624837
- Email: gokcekartal95@hotmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with Idiopathic Parkinson's Disease by a neurologist according to the UK Parkinson's Disease Association Brain Bank clinical diagnostic criteria
- H&Y Stage I-III
- Montreal Cognitive Assessment Scale MoCA≥21
- Having the necessary technological devices to participate in telerehabilitation
- Being able to walk 100 meters
- Having at least a primary school diploma
Exclusion Criteria:
- Presence of a neurological disorder other than Parkinson's disease
- Presence of any cardiopulmonary or musculoskeletal problem that affects gait and balance
- Receiving Deep Brain Stimulation (DBS) treatment or having undergone DBS surgery in the past
- Presence of vision or hearing problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-Management Group
The self-management group will perform the exercise programme prescribed by the physical therapist and tailored to the patient's needs via a web-based system twice a week for eight weeks, at a time of their choosing.
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The exercises will consist of stretching, strengthening, balance, and neuromotor exercises that the patient can perform independently at home.
|
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Active Comparator: Telerehabilitation Group
Telerehabilitation group will perform the exercise programme prescribed by the physical therapist and tailored to the patient's needs via a web-based system twice a week for eight weeks.
|
The exercises will consist of stretching, strengthening, balance, and neuromotor exercises that the patient can perform independently at home.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in motor impairment
Time Frame: Baseline and the end of the 8 weeks exercise program
|
The Unified Parkinson's Disease Rating Scale (UPDRS) is used to determine the symptoms and clinical severity of PD.
The UPDRS-III subscore will be used to assess changes in motor impairment.
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Baseline and the end of the 8 weeks exercise program
|
|
Change in behavioral regulations in exercise
Time Frame: Baseline and the end of the 8 weeks exercise program
|
Behavioral Regulations in Exercise Questionnaire-2 consists of 19 items and five subscales.
The subscales consist of external regulation, internalized regulation, defined regulation, internal regulation and lack of motivation.
It is a 5-point Likert-type scale scored between 0-4.
|
Baseline and the end of the 8 weeks exercise program
|
|
Change in lower extremity power and endurance
Time Frame: Baseline and the end of the 8 weeks exercise program
|
Five Times Sit to Stand Test will be used to measure repetitive movement performance.
The patient will be asked to sit down and stand up 5 times as quickly as possible, and this time will be recorded in seconds.
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Baseline and the end of the 8 weeks exercise program
|
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Change in walking speed
Time Frame: Baseline and the end of the 8 weeks exercise program
|
10-Meter Walk Test will be applied to assess walking speed.
The first 2 meters of the 14-meter distance are allocated for acceleration, the last 2 meters for deceleration, and the time taken to walk the 10-meter distance is recorded.
Walking speed is calculated in meters per second.
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Baseline and the end of the 8 weeks exercise program
|
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Change in mobility
Time Frame: Baseline and the end of the 8 weeks exercise program
|
Timed Up and Go Test is used to assess mobility, balance, and risk of falling.
The patient is asked to stand up from a chair, walk around a cone 3 meters away, and return to sit on the chair.
The total time is recorded using a stopwatch.
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Baseline and the end of the 8 weeks exercise program
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Change in body position
Time Frame: Baseline and the end of the 8 weeks exercise program
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Activities-Specific Balance Confidence is a measure that assesses a person's level of confidence in their balance both indoors and outdoors.
It consists of 16 different activities and is rated on a scale from no confidence (-0) to complete confidence (-100).
A higher score indicates a greater level of confidence in balance.
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Baseline and the end of the 8 weeks exercise program
|
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Change in quality of life
Time Frame: Baseline and the end of the 8 weeks exercise program
|
The Parkinson's Disease Quality of Life Questionnaire (PDQ-39) will be used to assess quality of life.
It consists of 39 items and is composed of 8 sub-parameters: mobility, activities of daily living, stigma, social support, communication, emotional well-being, and physical discomfort.
As the score increases, quality of life deteriorates.
|
Baseline and the end of the 8 weeks exercise program
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Semra Oğuz, PhD, Marmara University
Publications and helpful links
General Publications
- Bloem BR, Okun MS, Klein C. Parkinson's disease. Lancet. 2021 Jun 12;397(10291):2284-2303. doi: 10.1016/S0140-6736(21)00218-X. Epub 2021 Apr 10.
- Goetz CG, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stebbins GT, Stern MB, Tilley BC, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, Van Hilten JJ, LaPelle N. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Process, format, and clinimetric testing plan. Mov Disord. 2007 Jan;22(1):41-7. doi: 10.1002/mds.21198.
- Duncan RP, Leddy AL, Earhart GM. Five times sit-to-stand test performance in Parkinson's disease. Arch Phys Med Rehabil. 2011 Sep;92(9):1431-6. doi: 10.1016/j.apmr.2011.04.008.
- Franchignoni F, Giordano A, Ronconi G, Rabini A, Ferriero G. Rasch validation of the Activities-specific Balance Confidence Scale and its short versions in patients with Parkinson's disease. J Rehabil Med. 2014 Jun;46(6):532-9. doi: 10.2340/16501977-1808.
- Huang SL, Hsieh CL, Wu RM, Tai CH, Lin CH, Lu WS. Minimal detectable change of the timed "up & go" test and the dynamic gait index in people with Parkinson disease. Phys Ther. 2011 Jan;91(1):114-21. doi: 10.2522/ptj.20090126. Epub 2010 Oct 14.
- Dean CM, Richards CL, Malouin F. Walking speed over 10 metres overestimates locomotor capacity after stroke. Clin Rehabil. 2001 Aug;15(4):415-21. doi: 10.1191/026921501678310216.
- Fahn S. Unified Parkinson's disease rating scale. Recent developments in Parkinson's disease. 1987:153-63.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Parkinson Disease
- Health Services Administration
- Delivery of Health Care
- Therapeutics
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Telemedicine
- Patient Care Management
- Telerehabilitation
Other Study ID Numbers
- 949
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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