NCT06274866

Brief Summary

The aim of this study is to examine the effects of home-based exercise on pain-related factors, postural control and early functional parameters in individuals undergoing total hip arthroplasty. Forty-four individuals with hip osteoarthritis were included in current study. Individuals were randomized as study group (n=23) and control group (n=21) by drawing lots. Individuals in the study group were followed up with a personalized home-based exercise program for 6 weeks. Individuals in the control group were followed up with an exercise training brochure. The exercise program of the individuals in the study group was checked at two-week intervals and adjustments were made in the exercise program. All individuals were evaluated before the operation, 2 weeks after the operation, and 12 weeks after the operation, and their data were recorded. Range of motion was measured with an inclinometer, muscle strength was measured with a hand dynamometer, joint position sense was measured with a target angle test, pain was measured with a visual pain scale, leg length was measured with a tape measure, and finally, the Q angle was measured with a goniometer. In addition to these,Tampa kinesiophobia scale, Oxford hip score and international physical activity scale were used. Timed up-and-go test was used to evaluate functional performance. Foursquare step test was used to evaluate balance, and finally, tetrax posturography device was used to evaluate postural control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

February 2, 2024

Last Update Submit

July 30, 2025

Conditions

Keywords

Total Hip ArthroplastyHome Based Exercise ProgramBalancePainFunction

Outcome Measures

Primary Outcomes (9)

  • OXFORD HİP SCORE

    The Oxford Hip Score consists of 12 questions asking patients to describe their hip pain and function during the past 4 weeks. Each item uses a 5-point response scale with values from 0 to 4. An overall score is created by summing the responses to each of the 12 questions. The total score can range from 0 to 48 (most recent scoring system), where 0 is the worst possible score, indicating severe hip problems, and 48 is the best score, suggesting excellent hip function

    Prior to surgery, two weeks following surgery, and twelve weeks following surgery, the same measurements will be taken.

  • TAMPA SCALE FOR KINESİOPHOBİA

    It is a scale consisting of 17 questions created to measure fear of injury. The scale includes injury/re-injury and fear-avoidance parameters in work-related activities.A 4-point Likert scoring on the scale (I strongly disagree 1, I disagree 2, I agree 3, I completely agree 4) is used. Individuals receive a total score between 17-68. A high score on the scale indicates that the person has a high level of kinesiophobia. Scores over 37 points are interpreted as high kinesiophobia.

    Prior to surgery, two weeks following surgery, and twelve weeks following surgery, the same measurements will be taken.

  • İNTERNATİONAL PHYSİCAL ACTİVİTY QUESTİONAİRE (SHORT FORM)

    The short form records the activity of four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting. The original authors recommended the "last 7 day recall" version of the questionaire for physical activity surveillance.

    Prior to surgery, two weeks following surgery, and twelve weeks following surgery, the same measurements will be taken.

  • JOİNT POSİTİON SENSE ERROR TEST

    The range of motion in the hip flexion direction is determined to be tested as active movement and passive movement in the 30 ˚, 60 ˚ and 90 ˚ positions. Movement deviations from specified angles are recorded along with the degree of deviation. The joint position sense error increases with the amount of deviation from the anticipated angle.

    Prior to surgery, two weeks following surgery, and twelve weeks following surgery, the same measurements will be taken.

  • FOUR SQUARE STEP TEST

    It is a measurement of dynamic standing balance.Performance time is calculated for each individual. Prolonged performances indicate an absence of equilibrium.

    Prior to surgery, two weeks following surgery, and twelve weeks following surgery, the same measurements will be taken.

  • THE TİMED UP and GO TEST

    The timed up and go test measures in seconds the time it takes a subject to rise from a chair, walk a distance of 3 meters, turn, walk back to the chair and sit down. This test has been used to examine balance, gait speed, and functional ability that would be required for the performance of basic activities of daily living in older people.

    Prior to surgery, two weeks following surgery, and twelve weeks following surgery, the same measurements will be taken.

  • Assessment of Hip Muscle Strength

    A microFET®2 (Digital Hand-held Dynamometer, Hoggan Scientific, LLC; Salt Lake City, Utah) Hand-Held Dynamometer is going to used to measure muscle strength. Using the break test method, which reveals isometric muscle contraction during the muscle test, force is applied in the opposite direction until a joint movement occurred exceeding the maximum power applied with the dynamometer. The strength of the healthy and osteoarthritic hip muscles are evaluated with the patient in supine position. The measurements are recorded as Newton (N) units.

    Prior to surgery, two weeks following surgery, and twelve weeks following surgery, the same measurements will be taken.

  • Assessment of Hip Joint Range of Motion

    Individuals' hip joint range of motion will be evaluated using the Baseline Bubble® Inclinometer. Hip flexion and abduction active range of motion will be evaluated in the standing position, and hip rotations will be evaluated in the supine position. Decreased hip joint range of motion is a clinical precursor of hip osteoarthritis, characterized by pain and loss of function.

    Prior to surgery, two weeks following surgery, and twelve weeks following surgery, the same measurements will be taken.

  • Assessment of Postural Control

    To evaluate postural control, measurements will be made with a software-based static posturography device (Tetrax®, Sunlight Medical Ltd). Tetrax® consists of four independent platforms that measure vertical pressure changes from both toes and both heels, and a computer software that combines the digital data from this platform. The system can digitally record data from four different measurement platforms in a certain period of time and document it as visual and numerical values. While measuring, individuals place their bare feet on the platforms and stand comfortably in a quiet environment. Individuals hold their head and eyes open and closed. It is evaluated in 8 different positions using neck rotations. The software evaluates postural control by generating a stability index with a numerical value from all measurements.

    Prior to surgery, two weeks following surgery, and twelve weeks following surgery, the same measurements will be taken.

Secondary Outcomes (2)

  • MEASURİNG LEG LENGTH DİSCREPANCY

    Prior to surgery, two weeks following surgery, and twelve weeks following surgery, the same measurements will be taken.

  • Q ANGLE

    Prior to surgery, two weeks following surgery, and twelve weeks following surgery, the same measurements will be taken.

Study Arms (2)

Study Group

EXPERIMENTAL

After total hip arthroplasty, participants who take supervised home based exercised program which consists especially early weight bearing hip specific mobilization and strengthening exercises.

Other: exercise program

Control group

OTHER

After total hip arthroplasty, participants who take an educational booklet (about exercise program) at hospital stay

Other: control group

Interventions

Study group were followed up with a personalized home-based exercise program for 6 weeks. IThe exercise program of the individuals in the study group was checked at two-week intervals and adjustments were made in the exercise program

Also known as: educational supervised exercises
Study Group

Individuals in the control group were followed up with an exercise training brochure.

Also known as: educational booklet
Control group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having surgery with a diagnosis of osteoarthritis
  • Cases have unilateral hip osteoarthritis
  • Not having received physical therapy in the 6 months before the surgery
  • Total hip arthroplasty surgery should only be performed on posterior or posterolateral done with initiative

You may not qualify if:

  • Presence of Dementia, Neurological Deficit
  • Having other diseases that may affect balance (vertigo, previous CVO, neuropathy, epilepsy)
  • Being on medication that may affect balance (antidepressants, antiepileptics, antipsychotics)
  • Individuals who use alcohol heavily
  • End stage organ failure
  • Cancer patients under active treatment (except those in remission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • Davis AM, Perruccio AV, Ibrahim S, Hogg-Johnson S, Wong R, Streiner DL, Beaton DE, Cote P, Gignac MA, Flannery J, Schemitsch E, Mahomed NN, Badley EM. The trajectory of recovery and the inter-relationships of symptoms, activity and participation in the first year following total hip and knee replacement. Osteoarthritis Cartilage. 2011 Dec;19(12):1413-21. doi: 10.1016/j.joca.2011.08.007. Epub 2011 Aug 18.

    PMID: 21889596BACKGROUND
  • Pop T, Szymczyk D, Majewska J, Bejer A, Baran J, Bielecki A, Rusek W. The Assessment of Static Balance in Patients after Total Hip Replacement in the Period of 2-3 Years after Surgery. Biomed Res Int. 2018 Jan 4;2018:3707254. doi: 10.1155/2018/3707254. eCollection 2018.

    PMID: 29511678BACKGROUND
  • Ometti M, Brambilla L, Gatti R, Tettamanti A, La Cava T, Pironti P, Fraschini G, Salini V. Capsulectomy vs capsulotomy in total hip arthroplasty. Clinical outcomes and proprioception evaluation: Study protocol for a randomized, controlled, double blinded trial. J Orthop. 2019 Sep 12;16(6):526-533. doi: 10.1016/j.jor.2019.09.020. eCollection 2019 Nov-Dec.

    PMID: 31680746BACKGROUND
  • Trudelle-Jackson E, Emerson R, Smith S. Outcomes of total hip arthroplasty: a study of patients one year postsurgery. J Orthop Sports Phys Ther. 2002 Jun;32(6):260-7. doi: 10.2519/jospt.2002.32.6.260.

MeSH Terms

Conditions

Pain

Interventions

Resistance TrainingControl Groups

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
no blinding
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomize controlled two groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2024

First Posted

February 23, 2024

Study Start

January 10, 2023

Primary Completion

April 30, 2023

Study Completion

June 30, 2024

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations