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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorIstanbul University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Self-Management Education and Home Exercise Program

    Other intervention

    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 Booklet

    Behavioral

    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.

Treatment groups

55 Participants
are divided into 2 treatment groups
Group A: Self-Management Education and Home ExerciseExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

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

Other outcomes

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