Determinants of Physical Frailty in Parkinson's Disease: A Multi-Factorial Analysis
ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-85
SponsorAcibadem University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinically diagnosed Parkinson's disease
Hoehn and Yahr stage 1-3
Age 40 to 85 years
Mini-Mental State Examination (MMSE) score ≥24
Disqualifiers
Major depressive disorder or psychotic disorder
Advanced dementia
Severe cardiovascular or respiratory disease
Uncontrolled chronic systemic disease (e.g., diabetes mellitus or hypertension)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Observational Questionnaire and Functional Assessment
Other interventionThis 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (at the time of questionnaire administration)2
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.
Time frame
Baseline (at the time of questionnaire administration)3
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.
Time frame
Baseline (at the time of physical and questionnaire-based assessment)Secondary outcomes
1
Tampa Scale for Kinesiophobia (TSK) Total Score
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.
Time frame
Baseline (at the time of questionnaire administration)2
Physical Activity Scale for the Elderly (PASE) Total Score
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.
Time frame
Baseline (reflecting physical activity over the previous 7 days)3
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
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.
Time frame
Baseline (at the time of clinical assessment)Sponsors and contacts
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Source ClinicalTrials.gov