Determinants of Physical Frailty in Parkinson's Disease: A Multi-Factorial Analysis

July 14, 2026 updated by: Nuray Alaca, Acibadem University

Investigation of the Relationship Between Motor Imagery, Body Awareness, Kinesiophobia, Physical Activity, Symptom Severity, and Physical Frailty in Patients With Parkinson's Disease

The aim of this study is to examine the associations between motor imagery capacity, body awareness (interoceptive awareness), kinesiophobia, physical activity level, and symptom severity in individuals with Parkinson's disease. In addition, the study aims to evaluate the relationships between these variables and physical frailty. This cross-sectional observational study will provide insight into the biopsychosocial factors associated with frailty in Parkinson's disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of individuals with clinically diagnosed Parkinson's disease (Hoehn and Yahr stage 1-3), aged between 40 and 85 years, with adequate cognitive function (MMSE ≥ 24). Participants will be recruited from patients attending the Movement Disorders Outpatient Clinic of the Neurology Department. The study population represents ambulatory individuals with mild to moderate disease severity suitable for comprehensive biopsychosocial assessment.

Description

Inclusion Criteria:

  • Clinically diagnosed Parkinson's disease
  • Hoehn and Yahr stage 1-3
  • Age 40 to 85 years
  • Mini-Mental State Examination (MMSE) score ≥24
  • Attending the Movement Disorders Outpatient Clinic, Department of Neurology
  • Able to understand the study procedures and provide written informed consent

Exclusion Criteria:

  • Major depressive disorder or psychotic disorder
  • Advanced dementia
  • Severe cardiovascular or respiratory disease
  • Uncontrolled chronic systemic disease (e.g., diabetes mellitus or hypertension)
  • Additional neurological or orthopedic conditions that may affect assessment performance
  • Severe visual or hearing impairment that could interfere with study assessments
  • Inability to cooperate with the physiotherapist during study assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vividness of Movement Imagery Questionnaire-2 (VMIQ-2) Total and Subscale Scores
Time Frame: Baseline (at the time of questionnaire administration)
Motor imagery ability will be assessed using the Vividness of Movement Imagery Questionnaire-2 (VMIQ-2), a validated self-report instrument with established Turkish validity and reliability. The questionnaire consists of 12 items assessing the vividness of imagined movements across three domains: external visual imagery, internal visual imagery, and kinesthetic imagery. Each item is rated on a 5-point Likert scale (1-5), and separate scores are calculated for each subscale as well as a total score. Total scores range from 17 to 68, with higher scores indicating lower vividness of motor imagery ability. Assessments will be administered jointly by the responsible physician and a physiotherapist.
Baseline (at the time of questionnaire administration)
Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) Total and Subscale Scores
Time Frame: Baseline (at the time of questionnaire administration)
Interoceptive body awareness will be assessed using the Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2), a validated self-report instrument with established Turkish validity and reliability. The Turkish version consists of 34 items across seven subscales: Noticing, Not-Distracting, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trusting. Each item is rated on a 6-point Likert scale ranging from 0 (never) to 5 (always). Subscale scores are calculated separately, with higher scores indicating greater interoceptive body awareness in the respective domain.
Baseline (at the time of questionnaire administration)
Fried Frailty Phenotype (FFP) Classification and Total Criteria Score
Time Frame: Baseline (at the time of physical and questionnaire-based assessment)
Physical frailty will be assessed using the Fried Frailty Phenotype (FFP), a validated measure based on five criteria: unintentional weight loss, exhaustion, low physical activity, weak handgrip strength, and slow walking speed. Participants will be classified as robust (0 criteria), prefrail (1-2 criteria), or frail (≥3 criteria). Each criterion will be scored as present or absent, and a total score ranging from 0 to 5 will be calculated. In addition to the original criteria, population-specific cut-off values for handgrip strength (≤13.6 kg for women and ≤27.7 kg for men) will be applied. Higher scores indicate greater frailty.
Baseline (at the time of physical and questionnaire-based assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tampa Scale for Kinesiophobia (TSK) Total Score
Time Frame: Baseline (at the time of questionnaire administration)
Kinesiophobia (fear of movement) will be assessed using the Tampa Scale for Kinesiophobia (TSK), a validated 17-item self-report questionnaire evaluating fear of movement and re-injury. Each item is rated on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree). The total score ranges from 17 to 68, with higher scores indicating greater fear of movement. The Turkish version of the scale has demonstrated validity and reliability in clinical populations.
Baseline (at the time of questionnaire administration)
Physical Activity Scale for the Elderly (PASE) Total Score
Time Frame: Baseline (reflecting physical activity over the previous 7 days)
Physical activity level will be assessed using the Physical Activity Scale for the Elderly (PASE), a validated self-report questionnaire designed to evaluate physical activity in older adults. The scale consists of 12 items covering leisure time activities, household activities, and work-related physical activities performed over the previous 7 days. The total PASE score is calculated by multiplying activity frequency and duration by empirically derived item weights and summing across all activities. Scores range from 0 to over 400, with higher scores indicating higher levels of physical activity.
Baseline (reflecting physical activity over the previous 7 days)
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
Time Frame: Baseline (at the time of clinical assessment)
Symptom severity will be assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), a validated instrument evaluating motor and non-motor aspects of Parkinson's disease. The scale consists of four parts covering non-motor experiences of daily living, motor experiences of daily living, motor examination, and motor complications. Each item is rated from 0 (normal) to 4 (severe), and total and subscale scores are calculated. Higher scores indicate greater disease severity.
Baseline (at the time of clinical assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-03-131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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