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

NCT07488364 | Not Yet Recruiting

• 1 other identifier: 2026-03-131
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• Vividness of Movement Imagery Questionnaire-2 (VMIQ-2) Total and Subscale Scores

  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

  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

  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 Outcomes (3)

• Tampa Scale for Kinesiophobia (TSK) Total Score

  Baseline (at the time of questionnaire administration)

• Physical Activity Scale for the Elderly (PASE) Total Score

  Baseline (reflecting physical activity over the previous 7 days)

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

  Baseline (at the time of clinical assessment)

Interventions

Observational Questionnaire and Functional Assessment OTHER

This is a non-interventional, cross-sectional observational study. No therapeutic or experimental intervention will be administered. Participants will undergo a comprehensive assessment including validated self-report questionnaires and standardized performance-based tests to evaluate motor imagery capacity, interoceptive body awareness, kinesiophobia, physical activity level, symptom severity, and physical frailty. All data will be collected during a single assessment session for observational analysis.

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Clinically diagnosed Parkinson's disease
• Hoehn and Yahr stage 1-3
• Age between 40 and 85 years
• Adequate cognitive function (Mini-Mental State Examination \[MMSE\] score ≥ 24)
• Patients attending the Movement Disorders Outpatient Clinic of the Neurology Department
• Ability to understand study procedures and provide informed consent

You may not qualify if:

• Presence of psychiatric disorders (major depression, psychotic disorders)
• Diagnosis of advanced dementia
• Presence of severe cardiovascular or respiratory disease, or uncontrolled chronic systemic conditions (diabetes mellitus, hypertension)
• Presence of additional neurological or orthopedic conditions that may affect assessment performance
• Severe visual or hearing impairments that could interfere with testing procedures
• Inability to cooperate adequately with the physiotherapist during assessments

Sponsors & Collaborators

• Acibadem University: lead

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 23, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03