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Active, not recruitingNCT07817862Updated Oct 19, 2026

Effectiveness of a Home-Based Exercise Program Supported by Self-Management Education in People With Parkinson Disease

An interventional study of Self-Management Education and Home Exercise Program and Parkinson Disease Educational Booklet in PARKINSON DISEASE (Disorder), sponsored by Istanbul University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Istanbul University · Not applicable, Interventional, and Treatment

Updated Oct 19, 2026Now Active, not recruitingStart date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 171 studies in Parkinson Disease with a site in Turkey — 49 open to participants now, 56 under way, none of them phase 3. Parkinson Disease · Turkey.

Planned enrollment
15th of 98
55 · median 32
Started
2026
with 27 others
No phase
91 of 171
25 open now
Primary completion
2026-11
later than 35 of 55 live
Registered
166th of 171
by date
Lead sponsor
4 of 171
Istanbul University

Among the 171 studies in Parkinson Disease with a site in Turkey, this one is the 15th largest by planned enrollment of the 98 interventional ones, is one of 28 that started in 2026, is one of 91 with no phase, reaches primary completion later than 35 of the 55 other live ones, and was the 166th registered.

By phase

171 studies; the count open now beside each. This study's row is marked.

No phasethis study91 · 25 open
Observational73 · 23 open
Phase 33 · 0 open
Phase 43 · 1 open
Phase 21 · 0 open

By the year they started

First in 2004; this study’s year is marked. 28 started in 2026.

Size and results

Median enrollment 32 across the 98 interventional studies, 61 across the 73 observational. Of the 103 that completed or were terminated, 2 (2%) have results posted.

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02

Study 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. 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.

03

Conditions studied

  • PARKINSON DISEASE (Disorder)

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Keywords

  • Self-management
  • Home exercise
  • Rehabilitation
  • Balance
  • gait
  • Quality of life
  • Exercise adherence
04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
55 participants (estimated)

Study arms

  • Experimental
    Self-Management Education and Home Exercise

    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.

    Other: Self-Management Education and Home Exercise Program

  • Active comparator
    Control Group

    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.

    Behavioral: Parkinson Disease Educational Booklet

Interventions

  • OtherSelf-Management Education and Home Exercise Program

    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

  • BehavioralParkinson Disease Educational Booklet

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline, Week 8, and Week 16

Secondary outcomes

  1. 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

    Time frame: Baseline, Week 8, and Week 16

  2. 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

    Time frame: Baseline, Week 8, and Week 16

  3. 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

    Time frame: Baseline, Week 8, and Week 16

  4. 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

    Time frame: Baseline, Week 8, and Week 16

  5. 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

    Time frame: Baseline, Week 8, and Week 16

  6. 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

    Time frame: Baseline, Week 8, and Week 16

  7. Home Exercise Adherence

    Number of completed home exercise sessions recorded in the exercise log during the 8-week program.

    Time frame: Week 8

  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

    Time frame: baseline, week 8, week 16

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Nov 2026, 1 month after the start.

Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 1 month is below that.

Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2026
First posted
Sep 14, 2026
StartActual
Sep 17, 2026
Primary completionEst.
Nov 5, 2026
CompletionEst.
Dec 31, 2026
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Active, not recruiting
changed Oct 19, 2026
Start date
Sep 10, 2026→Sep 17, 2026 (actual)
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    Not yet recruiting→Active, not recruiting
    Start date Sep 10, 2026→Sep 17, 2026 (now actual)
    + 1 other change: contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07817862
Responsible party
Mehri Güner (MD, Istanbul University) — Principal investigator
First posted
Sep 14, 2026
Start date
Sep 17, 2026
Primary completion
Nov 5, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 19, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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