NCT07590700

Brief Summary

Falls are common in patients with Parkinson disease and may lead to reduced mobility, fear of falling, loss of independence, and injury. Exercise-based rehabilitation programs may help improve balance, gait, and physical performance in this population. This randomized controlled trial aims to compare the effectiveness of two home-based exercise programs in patients with Parkinson disease: the Otago Exercise Program and a structured home exercise program. Participants will be randomly assigned to one of two groups. Both groups will receive exercise education and will perform their assigned home exercise program for 6 weeks. Participants will be evaluated at baseline, at week 3, and at the end of week 6. The study will assess fall-related outcomes, freezing of gait, functional mobility, gait parameters, postural control, and physical performance. The results may help determine which home-based exercise approach is more effective for reducing fall risk and improving functional outcomes in patients with Parkinson disease.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Feb 2026Aug 2026

Study Start

First participant enrolled

February 8, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 10, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

parkinson diseasefall preventionOtagoHome-basedExecise

Outcome Measures

Primary Outcomes (1)

  • Falls Efficacy Scale

    Fall-related self-efficacy and fear of falling will be assessed using the Falls Efficacy Scale. The scale evaluates the participant's confidence in performing daily activities without falling. Scores range from 10 to 100, with lower scores indicating greater fear of falling and higher scores indicating lower fear of falling.

    Baseline, week 3, and week 6

Secondary Outcomes (6)

  • Freezing of Gait Questionnaire (FOGQ)

    Baseline, week 3, and week 6

  • Gait Speed

    Baseline, week 3, and week 6

  • Timed Up and Go Test

    Baseline, week 3, and week 6

  • Functional Reach Test

    Baseline, week 3, and week 6

  • Sit-to-Stand Test

    Baseline, week 3, and week 6

  • +1 more secondary outcomes

Study Arms (2)

Otago Home Exercise Program

EXPERIMENTAL

Participants in this arm will receive the Otago Home Exercise Program. The program includes home-based strengthening, static balance, and dynamic balance exercises designed to improve lower extremity muscle strength, balance, functional mobility, and fall-related outcomes. Participants will perform the exercises 3 times per week for 6 weeks, with each session lasting approximately 40 minutes. The exercise program will be reviewed and progressed at week 3 according to the participant's functional status.

Behavioral: Otago Home Exercise Program

Structured Home Exercise Program

ACTIVE COMPARATOR

Participants in this arm will receive a structured home exercise program. The program includes spinal stabilization exercises and stretching and strengthening exercises targeting the ankle plantar flexor and dorsiflexor muscles, quadriceps, lumbar extensor muscles, pectoral muscles, and hamstring muscles. Participants will perform the exercises 3 times per week for 6 weeks, with each session lasting approximately 40 minutes. The exercise program will be reviewed and progressed at week 3 according to the participant's functional status.

Behavioral: Structured Home Exercise Program

Interventions

nce exercises designed to improve lower extremity muscle strength, balance, functional mobility, and fall-related outcomes. Participants will perform the program 3 times per week for 6 weeks, with each session lasting approximately 40 minutes. The program will be reviewed and progressed at week 3.

Otago Home Exercise Program

The structured home exercise program is a home-based exercise intervention including spinal stabilization exercises and stretching and strengthening exercises targeting the ankle plantar flexor and dorsiflexor muscles, quadriceps, lumbar extensor muscles, pectoral muscles, and hamstring muscles. Participants will perform the program 3 times per week for 6 weeks, with each session lasting approximately 40 minutes. The program will be reviewed and progressed at week 3.

Structured Home Exercise Program

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Parkinson disease confirmed by a neurologist
  • Hoehn and Yahr stage 3 or 4 Parkinson disease
  • Diagnosis of Parkinson disease for at least 5 years
  • Willingness to participate in the study and provide written informed consent
  • Ability to walk independently or with minimal assistance
  • Mini-Mental State Examination score \>24

You may not qualify if:

  • Balance or gait impairment due to causes other than Parkinson disease, such as severe orthopedic problems or another neurological disease
  • Red flags suggestive of Parkinson-plus syndromes, such as symmetric onset, early falls, early-onset dementia, or gaze palsy
  • History of serious fall-related injury or surgery within the last 6 months
  • Any additional health condition that would prevent participation in the exercise program during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatay Mustafa Kemal University

Hatay, Antakya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Central Study Contacts

Selim GÜNAY, Asst Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: rcise Program group or the structured home exercise program group. Both interventions will be delivered as home-based exercise programs for 6 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

May 10, 2026

First Posted

May 15, 2026

Study Start

February 8, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations