PARKINSON DISEASE (Disorder)NCT07817862
Effectiveness of a Home-Based Exercise Program Supported by Self-Management Education in People With Parkinson Disease
A study testing Self-Management Education and Home Exercise Program and Parkinson Disease Educational Booklet in people with PARKINSON DISEASE (Disorder), run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This randomized, assessor-blinded clinical trial evaluates whether a structured self-management education and home exercise program improves balance, walking capacity, fall-related concerns, upper-extremity dexterity, and quality of life in adults with Parkinson disease. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Self-Management Education and Home Exercise Program and Parkinson Disease Educational Booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Sep 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson disease
- Age 45 to 80 years
- Parkinson disease diagnosed at least 1 year before enrollment
- Clinically stable, with no change in medication dose or treatment plan during the previous 3 months
- Modified Hoehn and Yahr stage 1 to 3
Who cannot join
- Cardiovascular, pulmonary, or systemic disease that may limit exercise participation
- Cognitive impairment or a communication barrier that prevents study participation
- Participation in a regular rehabilitation program during the previous 3 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine
Istanbul, Fatih, 34080
About this study
This randomized, assessor-blinded clinical trial evaluates whether a structured self-management education and home exercise program improves balance, walking capacity, fall-related concerns, upper-extremity dexterity, and quality of life in adults with Parkinson disease. Fifty-five participants aged 45-80 years will be randomized to an intervention or control arm. Outcomes will be assessed at baseline, after the 8-week intervention, and at Week 16. The primary outcome is the Berg Balance Scale.
Read the detailed description
Participants meeting the eligibility criteria at Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation will be assigned by a computer-generated randomization procedure to two parallel groups. The intervention group will receive a clinician-led self-management education session, supervised instruction in a home exercise program, an exercise video, an exercise log, and weekly telephone support to monitor and encourage adherence. The home exercise program will include posture, relaxation and deep-breathing exercises; active range-of-motion and stretching exercises for the upper and lower extremities; hip and knee strengthening; rhythmic gait training; and balance, coordination, and proprioception exercises. Participants will be instructed to perform the program three days per week for 30-45 minutes per session for eight weeks. The control group will receive a booklet containing general information about Parkinson disease and will continue to receive usual clinical care. The control group will not receive the structured self-management session, supervised exercise instruction, exercise video, prescribed home exercise program, or weekly adherence-support telephone calls during the study period. An assessor blinded to group allocation will perform outcome assessments at baseline, Week 8, and Week 16.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- Self-Management Education and Home Exercise Program, Parkinson Disease Educational Booklet
- Keywords
- Self-management, Home exercise, Rehabilitation, Balance, gait, Quality of life, Exercise adherence
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Management Education and Home Exercise ProgramOther
The program covers disease information and symptom-management strategies. Exercises include posture, relaxation and deep breathing; active range-of-motion and stretching for the upper and lower extremities; hip and knee strengthening; rhythmic gait training; and balance, coordination, and proprioception tasks including semi-tandem walking, weight shifting, and bending/returning upright. Weekly telephone contact is used to monitor and encourage adherence
Parkinson Disease Educational BookletBehavioural
Participants received an educational booklet containing general information about Parkinson disease and general exercise recommendations in addition to their standard medical treatment. No structured exercise program or additional follow-up was provided.
| Study group | Role | What they receive |
|---|---|---|
| Self-Management Education and Home Exercise | Experimental | Participants receive a clinician-led self-management education session; practical exercise instruction with a physiotherapist; an exercise video and educational booklet; an exercise log; and weekly telephone adherence support. The home exercise program is performed 3 days per week for 30-45 minutes per session for 8 weeks. Receives: Other: Self-Management Education and Home Exercise Program |
| Control Group | Active comparator | In addition to standard medical treatment, participants in the control group received an educational booklet containing general information about Parkinson disease and exercise recommendations. They did not receive a structured exercise program or any additional follow-up during the study. Receives: Behavioral: Parkinson Disease Educational Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale Score
The Berg Balance Scale is a short, safe, and simple balance test that measures an individual's ability to maintain balance while performing functional tasks. The scale consists of 14 items. Performance on each activity is rated using a five-point scale ranging from 0, "unable to perform," to 4, "able to perform independently and safely." The items assess activities in which maintaining position becomes progressively more difficult and the base of support is reduced. They include daily functional tasks such as standing unsupported, sitting unsupported, moving from standing to sitting, performing transfers, standing in tandem, and standing on one leg. The maximum total score is 56, with higher scores indicating better balance
Measured: Baseline, Week 8, and Week 16
Secondary outcomes (8)
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The MDS-UPDRS is a scale consisting of four main parts designed to evaluate Parkinson disease. Part I includes non-motor experiences of daily living and is divided into two subcomponents: Part IA is completed by the investigator using information obtained from the patient and caregiver, whereas Part IB is completed independently by the patient. Part II focuses on the patient's motor experiences of daily living and is designed as a self-administered questionnaire. Part III includes the motor examination and is administered by the assessor. Part IV evaluates motor complications and is completed using both information obtained from the patient and the assessor's clinical observations. Together, these four parts aim to provide a comprehensive evaluation of both the motor and non-motor effects of the disease
Measured: Baseline, Week 8, and Week 16
Timed Up and Go Test
The Timed Up and Go Test can be used to evaluate functional mobility. Patients are instructed to stand up from a chair, walk 3 meters, turn around, walk back, and sit down again. A marker should be used to indicate the end of the 3-meter distance, and patients who use an assistive device should use it during the test. The time is measured and recorded in seconds. A time of 10 seconds or less indicates that the patient can walk independently and has a low risk of falling. A time greater than 30 seconds indicates that the patient may occasionally require assistance and has a high risk of falling. In patients with Parkinson disease, a test duration longer than 11.5 seconds indicates an increased risk of falling
Measured: Baseline, Week 8, and Week 16
6-Minute Walk Test Distance
Walking capacity can be evaluated using the 6-Minute Walk Test, which is performed in a 30-meter-long corridor. Patients are instructed to complete as many laps as possible along the corridor, and the total distance walked at the end of 6 minutes is recorded. At the beginning of each minute, the administrator reminds the patient of the remaining time and provides verbal encouragement. Patients may use an assistive device if needed
Measured: Baseline, Week 8, and Week 16
Falls Efficacy Scale-International Score
The Falls Efficacy Scale was developed to evaluate fear of falling while performing 10 tasks related to activities of daily living. In 2005, because the FES developed by Tinetti et al. did not directly represent the relationship between fear of falling and self-efficacy, it was expanded into the 16-item Falls Efficacy Scale-International. The items of the FES are related to basic activities of daily living in older adults and do not evaluate social activities or fear of falling in broader life situations. In response to these criticisms, the wording and rating scale of the original FES were revised by replacing the term "confident" with "concerned." The total score ranges from 16, indicating no concern, to 64, indicating extreme concern
Measured: Baseline, Week 8, and Week 16
Parkinson's Disease Questionnaire-39 Score
The Parkinson's Disease Questionnaire-39 is a widely used self-report questionnaire designed to measure disease-specific quality of life in patients with Parkinson disease from their own perspective. It was first developed and validated in the United Kingdom in 1995. The instrument consists of 39 items divided into eight domains that measure different health-related areas affected to varying degrees in Parkinson disease. The eight domains are mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items), and bodily discomfort (3 items). Responses are based on each individual's experiences during the previous month and are rated on a five-point Likert scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = always. Higher scores indicate a greater impact of the disease on the relevant quality-of-life domain or on the individual's overall life experience
Measured: Baseline, Week 8, and Week 16
Box and Block Test
The Box and Block Test, developed and validated by Mathiowetz, is a method designed to evaluate individuals with manual dysfunction. The purpose of the test is to assess and measure manual dexterity and the functions of grasping, holding, and releasing objects. The assessment is performed using a box divided into two equal compartments. The patient is instructed to transfer small wooden blocks from one compartment to the other for one minute. After three trials with each hand, the number of blocks transferred is recorded separately for the right and left hands. The BBT is considered a rapid, simple, and reliable test that is commonly used in older individuals and people who have experienced a stroke
Measured: Baseline, Week 8, and Week 16
Home Exercise Adherence
Number of completed home exercise sessions recorded in the exercise log during the 8-week program.
Measured: Week 8
Modified Hoehn and Yahr Staging
The staging system developed by Hoehn and Yahr in 1967 classifies the disease into five stages and allows both patients and clinicians to easily define disease severity and evaluate progression. Stages 1.5 and 2.5 were added to the Modified Hoehn and Yahr staging scale. In the literature, stages 1 and 2 are classified as "mild," stage 3 as "moderate," and stages 4 and 5 as stages involving "severe" signs and symptoms
Measured: baseline, week 8, week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start17 Sep 2026
- Primary completion5 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehri Güner, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817862
- Sponsor's protocol ID
- E-29624016-050.99-3324589
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Home-Based Exercise Program Supported by Self-Management Education in People With Parkinson Disease
- ClinicalTrials.gov ID
- NCT07817862
- Acronym / sponsor ID
- E-29624016-050.99-3324589
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- Self-management, Home exercise, Rehabilitation, Balance, gait, Quality of life, Exercise adherence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Sep 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.
This randomized, assessor-blinded clinical trial evaluates whether a structured self-management education and home exercise program improves balance, walking capacity, fall-related concerns, upper-extremity dexterity, and quality of life in adults with Parkinson disease. Fifty-five participants aged 45-80 years will be randomized to an intervention or control arm. Outcomes will be assessed at baseline, after the 8-week intervention, and at Week 16. The primary outcome is the Berg Balance Scale.
Detailed description
Participants meeting the eligibility criteria at Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation will be assigned by a computer-generated randomization procedure to two parallel groups. The intervention group will receive a clinician-led self-management education session, supervised instruction in a home exercise program, an exercise video, an exercise log, and weekly telephone support to monitor and encourage adherence. The home exercise program will include posture, relaxation and deep-breathing exercises; active range-of-motion and stretching exercises for the upper and lower extremities; hip and knee strengthening; rhythmic gait training; and balance, coordination, and proprioception exercises. Participants will be instructed to perform the program three days per week for 30-45 minutes per session for eight weeks. The control group will receive a booklet containing general information about Parkinson disease and will continue to receive usual clinical care. The control group will not receive the structured self-management session, supervised exercise instruction, exercise video, prescribed home exercise program, or weekly adherence-support telephone calls during the study period. An assessor blinded to group allocation will perform outcome assessments at baseline, Week 8, and Week 16.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Management Education and Home Exercise | Experimental | Other: Self-Management Education and Home Exercise ProgramParticipants receive a clinician-led self-management education session; practical exercise instruction with a physiotherapist; an exercise video and educational booklet; an exercise log; and weekly telephone adherence support. The home exercise program is performed 3 days per week for 30-45 minutes per session for 8 weeks. |
| Control Group | Active comparator | Behavioral: Parkinson Disease Educational BookletIn addition to standard medical treatment, participants in the control group received an educational booklet containing general information about Parkinson disease and exercise recommendations. They did not receive a structured exercise program or any additional follow-up during the study. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of Parkinson disease
- Age 45 to 80 years
- Parkinson disease diagnosed at least 1 year before enrollment
- Clinically stable, with no change in medication dose or treatment plan during the previous 3 months
- Modified Hoehn and Yahr stage 1 to 3
Key exclusion criteria (3 listed)
- Cardiovascular, pulmonary, or systemic disease that may limit exercise participation
- Cognitive impairment or a communication barrier that prevents study participation
- Participation in a regular rehabilitation program during the previous 3 months
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 |
|---|---|---|
| Self-Management Education and Home Exercise ProgramThe program covers disease information and symptom-management strategies. Exercises include posture, relaxation and deep breathing; active range-of-motion and stretching for the upper and lower extremities; hip and knee strengthening; rhythmic gait training; and balance, coordination, and proprioception tasks including semi-tandem walking, weight shifting, and bending/returning upright. Weekly telephone contact is used to monitor and encourage adherence | Other | Self-Management Education and Home Exercise |
| Parkinson Disease Educational BookletParticipants received an educational booklet containing general information about Parkinson disease and general exercise recommendations in addition to their standard medical treatment. No structured exercise program or additional follow-up was provided. | Behavioural | Control Group |
Primary outcome
Berg Balance Scale Score
Time frame: Baseline, Week 8, and Week 16
The Berg Balance Scale is a short, safe, and simple balance test that measures an individual's ability to maintain balance while performing functional tasks. The scale consists of 14 items. Performance on each activity is rated using a five-point scale ranging from 0, "unable to perform," to 4, "able to perform independently and safely." The items assess activities in which maintaining position becomes progressively more difficult and the base of support is reduced. They include daily functional tasks such as standing unsupported, sitting unsupported, moving from standing to sitting, performing transfers, standing in tandem, and standing on one leg. The maximum total score is 56, with higher scores indicating better balance
8 secondary outcomes
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: Baseline, Week 8, and Week 16
Timed Up and Go Test
Time frame: Baseline, Week 8, and Week 16
6-Minute Walk Test Distance
Time frame: Baseline, Week 8, and Week 16
Falls Efficacy Scale-International Score
Time frame: Baseline, Week 8, and Week 16
Parkinson's Disease Questionnaire-39 Score
Time frame: Baseline, Week 8, and Week 16
Box and Block Test
Time frame: Baseline, Week 8, and Week 16
Home Exercise Adherence
Time frame: Week 8
Modified Hoehn and Yahr Staging
Time frame: baseline, week 8, week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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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 Self-Management Education and Home Exercise Program and Parkinson Disease Educational Booklet in people with PARKINSON DISEASE (Disorder), run by Istanbul 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Berg Balance Scale Score (time frame: Baseline, Week 8, and Week 16). 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 19 Oct 2026.