PARKINSON DISEASE (Disorder)NCT07590700
Home-Based Exercise Programs for Fall Prevention in Parkinson Disease
A study testing Otago Home Exercise Program and Structured Home Exercise Program in people with PARKINSON DISEASE (Disorder) and Falls Prevention, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Falls Prevention, Exercise
- What is being tested?
- Otago Home Exercise Program and Structured Home Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Feb 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- PARKINSON DISEASE (Disorder), Falls Prevention, Exercise
- Being tested
- Otago Home Exercise Program, Structured Home Exercise Program
- Keywords
- parkinson disease, fall prevention, Otago, Home-based, Execise
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago Home Exercise ProgramBehavioural
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.
Structured Home Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Otago Home Exercise Program | Experimental | 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. Receives: Behavioral: Otago Home Exercise Program |
| Structured Home Exercise Program | Active comparator | 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. Receives: Behavioral: Structured Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freezing of Gait Questionnaire (FOGQ)
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.
Measured: Baseline, week 3, and week 6
Secondary outcomes (5)
Falls Efficacy Scale
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.
Measured: Baseline, week 3, and week 6
Timed Up and Go Test
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.
Measured: Baseline, week 3, and week 6
Functional Reach Test
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.
Measured: Baseline, week 3, and week 6
Sit-to-Stand Test
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.
Measured: Baseline, week 3, and week 6
Gait Initiation Time
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.
Measured: Baseline, week 3, and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start8 Feb 2026
- Primary completion1 Jul 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- rcise Program group or the structured home exercise program group. Both interventions will be delivered as home-based exercise programs for 6 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selim Mahmut GÜNAY, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590700
- Sponsor's protocol ID
- 2025/02-44
- Status last verified
- Aug 2026
- First submitted
- 10 May 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Fall-Preventive Home Exercise Programs in Patients With Parkinson Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07590700
- Acronym / sponsor ID
- 2025/02-44
- Conditions
- PARKINSON DISEASE (Disorder), Falls Prevention, Exercise
- Keywords
- parkinson disease, fall prevention, Otago, Home-based, Execise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 8 Feb 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- rcise Program group or the structured home exercise program group. Both interventions will be delivered as home-based exercise programs for 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| Otago Home Exercise Program | Experimental | Behavioral: Otago Home Exercise ProgramParticipants 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. |
| Structured Home Exercise Program | Active comparator | Behavioral: Structured Home Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Otago Home Exercise Programnce 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. | Behavioural | Otago Home Exercise Program |
| Structured Home Exercise ProgramThe 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. | Behavioural | Structured Home Exercise Program |
Primary outcome
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.
5 secondary outcomes
Falls Efficacy Scale
Time frame: Baseline, week 3, and week 6
Timed Up and Go Test
Time frame: Baseline, week 3, and week 6
Functional Reach Test
Time frame: Baseline, week 3, and week 6
Sit-to-Stand Test
Time frame: Baseline, week 3, and week 6
Gait Initiation Time
Time frame: Baseline, week 3, and week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otago Home Exercise Program and Structured Home Exercise Program in people with PARKINSON DISEASE (Disorder) and Falls Prevention, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freezing of Gait Questionnaire (FOGQ) (time frame: Baseline, week 3, and week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.