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

NCT07817862 | Not Yet Recruiting

• 1 other identifier: E-29624016-050.99-3324589
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PARKINSON DISEASE (Disorder)

Keywords

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

Outcome Measures

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

  Baseline, Week 8, and Week 16

Secondary Outcomes (8)

• Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  Baseline, Week 8, and Week 16

• Timed Up and Go Test

  Baseline, Week 8, and Week 16

• 6-Minute Walk Test Distance

  Baseline, Week 8, and Week 16

• Falls Efficacy Scale-International Score

  Baseline, Week 8, and Week 16

• Parkinson's Disease Questionnaire-39 Score

  Baseline, Week 8, and Week 16

Study Arms (2)

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.

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.

Behavioral: Parkinson Disease Educational Booklet

Interventions

Self-Management Education and Home Exercise Program OTHER

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

Self-Management Education and Home Exercise

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.

Control Group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, Fatih, 34080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Mehri Güner, MD

CONTACT

+905428125439; mehriguner@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments are performed by a researcher who is blinded to group allocation. Participants and personnel delivering the behavioral intervention cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 14, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): November 5, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 14, 2026

Record last verified: 2026-09

Locations

TU (1)