- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07590700
Home-Based Exercise Programs for Fall Prevention in Parkinson Disease
Effectiveness of Fall-Preventive Home Exercise Programs in Patients With Parkinson Disease: A Randomized Controlled Trial
Falls are common in patients with Parkinson disease and may lead to reduced mobility, fear of falling, loss of independence, and injury. Exercise-based rehabilitation programs may help improve balance, gait, and physical performance in this population.
This randomized controlled trial aims to compare the effectiveness of two home-based exercise programs in patients with Parkinson disease: the Otago Exercise Program and a structured home exercise program. Participants will be randomly assigned to one of two groups. Both groups will receive exercise education and will perform their assigned home exercise program for 6 weeks.
Participants will be evaluated at baseline, at week 3, and at the end of week 6. The study will assess fall-related outcomes, freezing of gait, functional mobility, gait parameters, postural control, and physical performance. The results may help determine which home-based exercise approach is more effective for reducing fall risk and improving functional outcomes in patients with Parkinson disease.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Selim GÜNAY, Asst Prof
- Phone Number: +90 539 462 8521
- Email: mgselim1@gmail.com
Study Locations
-
-
Antakya
-
Hatay, Antakya, Turkey (Türkiye)
- Recruiting
- Hatay Mustafa Kemal University
-
Contact:
- Selim Mahmut Günay
- Phone Number: +905394628521
- Email: mgselim1@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of Parkinson disease confirmed by a neurologist
- Hoehn and Yahr stage 3 or 4 Parkinson disease
- Diagnosis of Parkinson disease for at least 5 years
- Willingness to participate in the study and provide written informed consent
- Ability to walk independently or with minimal assistance
- Mini-Mental State Examination score >24
Exclusion Criteria:
- Balance or gait impairment due to causes other than Parkinson disease, such as severe orthopedic problems or another neurological disease
- Red flags suggestive of Parkinson-plus syndromes, such as symmetric onset, early falls, early-onset dementia, or gaze palsy
- History of serious fall-related injury or surgery within the last 6 months
- Any additional health condition that would prevent participation in the exercise program during the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Otago Home Exercise Program
Participants in this arm will receive the Otago Home Exercise Program.
The program includes home-based strengthening, static balance, and dynamic balance exercises designed to improve lower extremity muscle strength, balance, functional mobility, and fall-related outcomes.
Participants will perform the exercises 3 times per week for 6 weeks, with each session lasting approximately 40 minutes.
The exercise program will be reviewed and progressed at week 3 according to the participant's functional status.
|
nce exercises designed to improve lower extremity muscle strength, balance, functional mobility, and fall-related outcomes.
Participants will perform the program 3 times per week for 6 weeks, with each session lasting approximately 40 minutes.
The program will be reviewed and progressed at week 3.
|
|
Active Comparator: Structured Home Exercise Program
Participants in this arm will receive a structured home exercise program.
The program includes spinal stabilization exercises and stretching and strengthening exercises targeting the ankle plantar flexor and dorsiflexor muscles, quadriceps, lumbar extensor muscles, pectoral muscles, and hamstring muscles.
Participants will perform the exercises 3 times per week for 6 weeks, with each session lasting approximately 40 minutes.
The exercise program will be reviewed and progressed at week 3 according to the participant's functional status.
|
The structured home exercise program is a home-based exercise intervention including spinal stabilization exercises and stretching and strengthening exercises targeting the ankle plantar flexor and dorsiflexor muscles, quadriceps, lumbar extensor muscles, pectoral muscles, and hamstring muscles.
Participants will perform the program 3 times per week for 6 weeks, with each session lasting approximately 40 minutes.
The program will be reviewed and progressed at week 3.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Falls Efficacy Scale
Time Frame: Baseline, week 3, and week 6
|
Fall-related self-efficacy and fear of falling will be assessed using the Falls Efficacy Scale.
The scale evaluates the participant's confidence in performing daily activities without falling.
Scores range from 10 to 100, with lower scores indicating greater fear of falling and higher scores indicating lower fear of falling.
|
Baseline, week 3, and week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait Speed
Time Frame: Baseline, week 3, and week 6
|
Gait speed will be assessed using video-based kinematic analysis with Kinovea software.
Walking speed will be calculated in meters per second from recorded walking trials.
Higher gait speed indicates better walking performance.
|
Baseline, week 3, and week 6
|
|
Timed Up and Go Test
Time Frame: Baseline, week 3, and week 6
|
r, walk a short distance, turn, walk back, and sit down.
The time required to complete the test will be recorded in seconds, with longer times indicating poorer functional mobility.
|
Baseline, week 3, and week 6
|
|
Functional Reach Test
Time Frame: Baseline, week 3, and week 6
|
The Functional Reach Test will be used to assess dynamic balance and postural control.
The maximum distance the participant can reach forward while standing without losing balance will be recorded in centimeters.
Greater reach distance indicates better functional balance.
|
Baseline, week 3, and week 6
|
|
Sit-to-Stand Test
Time Frame: Baseline, week 3, and week 6
|
The sit-to-stand task will be used to assess functional lower extremity performance and postural control during transition from sitting to standing.
The time required to complete the movement will be recorded in seconds using video-based analysis.
|
Baseline, week 3, and week 6
|
|
Gait Initiation Time
Time Frame: Baseline, week 3, and week 6
|
Gait initiation time will be assessed using video-based kinematic analysis.
The time from the auditory cue to the initiation of the first step will be recorded in seconds.
Longer times indicate impaired gait initiation.
|
Baseline, week 3, and week 6
|
|
Freezing of Gait Questionnaire (FOGQ)
Time Frame: Baseline, week 3, and week 6
|
Freezing of gait will be assessed using the Freezing of Gait Questionnaire (FOGQ).
The FOGQ evaluates the severity of freezing episodes and their impact on walking performance in patients with Parkinson disease.
The total score ranges from 0 to 24.
Higher scores indicate more severe freezing of gait and worse walking performance.
|
Baseline, week 3, and week 6
|
Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- 2025/02-44
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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