Effects Of A Home Based Exercise Program Following Total Hip Arthroplasty

PHYSIOTHERAPY Clinical Trial

Official title:

Investigation Of The Effects Of A Home Based Exercise Program Under Physiotherapist Supervision Following Total Hip Arthroplasty And Comparison With The Control Group

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06274866
• Other study ID #: dsahinoglu
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Halic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The aim of this study was to examine the patients who underwent Total Hip Arthroplasty surgery with the diagnosis of hip osteoarthritis. Home-based exercise program given individually under the control of a physiotherapist is effective in reducing pain. related factors (joint range of motion, muscle strength, kinesiophobia, physical activity), To investigate its effect on functional status, balance and postural control.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• PHYSIOTHERAPY

Intervention

Other:
• exercise program
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
• control group
Individuals in the control group were followed up with an exercise training brochure.

Locations

Country	Name	City	State
Turkey	Yeditepe Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Halic University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OXFORD HIP 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.
Primary	TAMPA SCALE FOR KINESIOPHOBIA	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.
Primary	INTERNATIONAL PHYSICAL ACTIVITY QUESTIONAIRE (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.
Primary	JOINT POSITION 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.
Primary	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.
Primary	THE TIMED 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.
Primary	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.
Primary	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.
Primary	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	MEASURING LEG LENGTH DISCREPANCY	Leg length will be recorded in cm by measuring the distance between the major trochanter and the medial malleolus with a 6 mm tape measure.	Prior to surgery, two weeks following surgery, and twelve weeks following surgery, the same measurements will be taken.
Secondary	Q ANGLE	The patients are placed in the supine position, and the axis between the tibial tubercle and the midpoint of the patella is measured along with the axis between the spina iliaca anterior superior and the midpoint of the patella. The angle value between these two axes is then recorded numerically. Goniometers are used to take measurements.	Prior to surgery, two weeks following surgery, and twelve weeks following surgery, the same measurements will be taken.