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NCT Number: NCT07488364

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

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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Acibadem University

Istanbul, Turkey, +90, Turkey (Türkiye)

Location status: Recruiting

Location contact

Nuray ALACA

CONTACT

[email protected]

05324251290

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nuray ALACA

CONTACT

[email protected]

05324251290

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 23, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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