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

2026. szeptember 9. frissítette: Mehri Güner, Istanbul University
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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

55

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Törökország (Türkiye)
    • Fatih
      • Istanbul, Fatih, Törökország (Türkiye), 34080
        • Istanbul University, Istanbul Faculty of Medicine
        • Kapcsolatba lépni:
          • Ekin Ilke SEN, MD
          • Telefonszám: +90 212 414 20 00

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

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:

  • 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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.
Egyéb: Self-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
Aktív összehasonlító: 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.
Viselkedési: Parkinson 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Berg Balance Scale Score
Időkeret: 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
Baseline, Week 8, and Week 16

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Időkeret: Baseline, Week 8, and Week 16
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
Baseline, Week 8, and Week 16
Timed Up and Go Test
Időkeret: Baseline, Week 8, and Week 16
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
Baseline, Week 8, and Week 16
6-Minute Walk Test Distance
Időkeret: Baseline, Week 8, and Week 16
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
Baseline, Week 8, and Week 16
Falls Efficacy Scale-International Score
Időkeret: Baseline, Week 8, and Week 16
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
Baseline, Week 8, and Week 16
Parkinson's Disease Questionnaire-39 Score
Időkeret: Baseline, Week 8, and Week 16
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
Baseline, Week 8, and Week 16
Box and Block Test
Időkeret: Baseline, Week 8, and Week 16
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
Baseline, Week 8, and Week 16
Home Exercise Adherence
Időkeret: Week 8
Number of completed home exercise sessions recorded in the exercise log during the 8-week program.
Week 8
Modified Hoehn and Yahr Staging
Időkeret: baseline, week 8, week 16
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
baseline, week 8, week 16

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Istanbul University

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. szeptember 10.

Elsődleges befejezés (Becsült)

2026. november 5.

A tanulmány befejezése (Becsült)

2026. december 31.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. szeptember 4.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 9.

Első közzététel (Tényleges)

2026. szeptember 14.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. szeptember 14.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 9.

Utolsó ellenőrzés

2026. szeptember 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • E-29624016-050.99-3324589

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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