Effectiveness of a Home-Based Exercise Program Supported by Self-Management Education in People With Parkinson Disease
9 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
55
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Mehri Güner, MD
- Número de telefone: +905428125439
- E-mail: mehriguner@gmail.com
Locais de estudo
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Fatih
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Istanbul, Fatih, Turquia (Türkiye), 34080
- Istanbul University, Istanbul Faculty of Medicine
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Contato:
- Ekin Ilke SEN, MD
- Número de telefone: +90 212 414 20 00
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
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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
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Comparador Ativo: 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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Berg Balance Scale Score
Prazo: Baseline, Week 8, and Week 16
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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
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Baseline, Week 8, and Week 16
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Prazo: Baseline, Week 8, and Week 16
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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
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Baseline, Week 8, and Week 16
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Timed Up and Go Test
Prazo: Baseline, Week 8, and Week 16
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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
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Baseline, Week 8, and Week 16
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6-Minute Walk Test Distance
Prazo: Baseline, Week 8, and Week 16
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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
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Baseline, Week 8, and Week 16
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Falls Efficacy Scale-International Score
Prazo: Baseline, Week 8, and Week 16
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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
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Baseline, Week 8, and Week 16
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Parkinson's Disease Questionnaire-39 Score
Prazo: Baseline, Week 8, and Week 16
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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
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Baseline, Week 8, and Week 16
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Box and Block Test
Prazo: Baseline, Week 8, and Week 16
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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
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Baseline, Week 8, and Week 16
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Home Exercise Adherence
Prazo: Week 8
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Number of completed home exercise sessions recorded in the exercise log during the 8-week program.
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Week 8
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Modified Hoehn and Yahr Staging
Prazo: baseline, week 8, week 16
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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
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baseline, week 8, week 16
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Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
10 de setembro de 2026
Conclusão Primária (Estimado)
5 de novembro de 2026
Conclusão do estudo (Estimado)
31 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
4 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de setembro de 2026
Primeira postagem (Real)
14 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
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Outros números de identificação do estudo
- E-29624016-050.99-3324589
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Não
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