NCT07272876

Brief Summary

This study aims to investigate how kinesiophobia (fear of movement), pain intensity, and physical performance are related in older adults experiencing musculoskeletal pain. Musculoskeletal pain is highly common in the elderly due to age-related degenerative changes, such as osteoarthritis, chronic low back pain, osteoporosis, and muscle weakness. These conditions often lead to reduced mobility, impaired balance, and limitations in daily living activities. As a result, many older adults may avoid physical activity due to fear of pain or reinjury, which may further decrease their functional capacity. The primary purpose of this study is to understand whether kinesiophobia contributes to lower physical performance in elderly individuals who have musculoskeletal pain. The study will also examine how pain intensity relates to balance, upper and lower limb strength, and overall functional ability. Participants aged 65 years and older will complete a set of standard assessments in a single 30-minute session. Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia, a 17-item questionnaire designed to assess fear of movement and avoidance behaviors. Balance will be evaluated with the Berg Balance Scale, which includes 14 tasks commonly performed in daily life. Lower limb strength will be assessed with the 30-Second Sit-to-Stand Test, while upper limb strength will be measured with a handgrip dynamometer. Understanding these relationships may help clinicians design better rehabilitation programs that reduce fear, improve physical performance, and support healthy aging. The findings of this study may also contribute to strategies for preventing disability and promoting independence in older adults with musculoskeletal pain.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

October 23, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2026

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

November 26, 2025

Last Update Submit

December 9, 2025

Conditions

Keywords

musculoskeletal painPhysical PerformanceGeriatricsKinesiophobia

Outcome Measures

Primary Outcomes (1)

  • Kinesiophobia Level (Tampa Scale of Kinesiophobia Score)

    Kinesiophobia will be assessed using the Tampa Scale of Kinesiophobia (TSK), a 17-item self-report questionnaire. Each item is scored from 1 (strongly disagree) to 4 (strongly agree), yielding a total score range of 17 to 68. Higher scores indicate greater fear of movement and higher levels of avoidance behavior.

    At a single assessment session (approximately 30 minutes after enrollment).

Secondary Outcomes (4)

  • Balance Performance (Berg Balance Scale Score)

    At a single assessment session (approximately 30 minutes after enrollment).

  • Lower Limb Strength and Functional Performance (30-Second Sit-to-Stand Test Repetitions)

    At a single assessment session (approximately 30 minutes after enrollment).

  • Upper Limb Strength (Handgrip Dynamometry)

    At a single assessment session (approximately 30 minutes after enrollment).

  • Pain Intensity (Numeric Rating Scale)

    At a single assessment session (approximately 30 minutes after enrollment).

Study Arms (1)

Elderly Individuals With Musculoskeletal Pain

This cohort consists of community-dwelling adults aged 65 years and older who are experiencing musculoskeletal pain. Participants in this group present with age-related degenerative musculoskeletal conditions that may affect movement, balance, and functional ability. All individuals in this cohort undergo standardized assessments of kinesiophobia, pain intensity, and physical performance. The cohort reflects a population with chronic musculoskeletal symptoms but without distinctions based on specific diagnoses, treatment exposure, or disease severity.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be community-dwelling older adults recruited from local geriatric outpatient clinics, physiotherapy centers, and community health facilities. The study population will primarily consist of individuals aged 65 years and above who seek evaluation or follow-up care related to musculoskeletal health, mobility, or general functional status within these clinical and community settings.

You may qualify if:

  • Being over 65 years of age
  • Having musculoskeletal pain
  • Having the ability to read, write, and understand Turkish

You may not qualify if:

  • Presence of any neurological disease
  • Presence of a mental health problem that would prevent participation in the study
  • Presence of a metabolic disease such as diabetes or hypothyroidism
  • Presence of a malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Musculoskeletal PainKinesiophobia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Zeynep Kaçar Akkoç

    Istinye University

    PRINCIPAL INVESTIGATOR
  • Zeynep Kaçar Akkoç

    zeynep.kacar@stu.istinye.edu.tr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 9, 2025

Study Start

October 23, 2025

Primary Completion

December 30, 2025

Study Completion

January 25, 2026

Last Updated

December 17, 2025

Record last verified: 2025-12

Locations