- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07307118
Functional Hip Strength Improvement in Knee Osteoarthritis Following Single-Dose PRP and a 6-Week Home Exercise Program
December 13, 2025 updated by: Muharrem Gökhan Beydağı, Firat University
Functional Hip Strength and Pain Changes in Women With Knee Osteoarthritis Following a Single-Dose Intra-Articular Platelet-Rich Plasma Injection and a 6-Week Home Exercise Program: A Single-Group Longitudinal Study
This single-group longitudinal study evaluated changes in hip stability isometric strength, knee muscle strength, and activity-related pain in women with knee osteoarthritis following a single-dose intra-articular platelet-rich plasma (PRP) injection and a 6-week home exercise program.
Outcomes were assessed at baseline (5 days post-injection), week 6, and week 12.
The intervention included strengthening exercises for knee and hip muscle groups performed three times per week and regular walking encouragement with weekly phone follow-up for adherence.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants with unilateral symptomatic knee osteoarthritis performed a standardized 6-week home strengthening program (knee extensors/flexors; hip extensors/abductors/external rotators) three times weekly and were encouraged to walk regularly.
Hip Stability Isometric Test (HipSIT), quadriceps/hamstring strength (hand-held dynamometry, normalized to body mass), and activity pain (VAS 0-10) were measured at baseline, week 6, and week 12 to evaluate functional strength and symptom changes after PRP plus exercise.
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
MErkez
-
Elâzığ, MErkez, Turkey (Türkiye), 23200
- Fırat Üniversitesi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Female patients aged 45-70 years.
- Radiographic knee osteoarthritis: Kellgren-Lawrence grade II-III in the affected knee and grade II or less in the unaffected knee.
- Unilateral knee pain during activity with VAS score ≥5 (for at least the past 3 months).
- Referred to physiotherapy following a unilateral single-dose PRP injection.
Exclusion Criteria:
- Any intra-articular knee injection within the past 6 months.
- Regular lower-extremity strengthening exercise or non-pharmacological treatment for knee OA within the past 6 weeks.
- History of lower-extremity surgery.
- History of neurological, rheumatological and/or cognitive diseases.
- Unable to use a telephone.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single Group: PRP Injection + Home Exercise Program
All participants received a unilateral single-dose intra-articular platelet-rich plasma (PRP) injection for symptomatic knee osteoarthritis, followed by a 6-week home-based strengthening and functional exercise program performed 3 times per week.
The exercise program targeted knee extensors/flexors and hip extensors/abductors/external rotators.
Participants were encouraged to walk at least 30 minutes on at least 5 days per week and were contacted weekly by phone to support adherence.
|
A single unilateral intra-articular autologous platelet-rich plasma (PRP) injection was administered to the affected knee.
Baseline assessments were conducted 5 days following the injection.
Other Names:
Home-based exercise program performed 3 times per week for 6 weeks, designed to strengthen knee extensors/flexors and hip extensors/abductors/external rotators.
Exercises included: quadriceps strengthening (supine isometric contractions with 5-second hold; seated knee extension with 5-second hold; straight leg raise with 5-second hold), hamstring strengthening (supine isometric contractions with 5-second hold; prone active knee flexion with 5-second hold), hip stabilizer strengthening (clamshells and side-lying hip abduction with 5-second hold), and functional exercises (step-ups, forward touchdowns from a step, side stepping, sit-to-stand from a chair without using arms, and partial wall squats), typically 10-15 repetitions.
Participants were also encouraged to walk at least 30 minutes on at least 5 days per week, and adherence was supported via weekly telephone contact.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hip Stability Isometric Test (HipSIT) strength (N/kg), affected side
Time Frame: Baseline (5 days post PRP injection), Week 6, Week 12
|
Hip stability isometric strength (combined hip extensor, abductor and external rotator maximum isometric strength) assessed using a hand-held dynamometer during the Hip Stability Isometric Test (HipSIT).
The test is performed in side-lying "clam" position (hip 45° flexion, knee 90° flexion).
Three maximal trials (5 seconds each) are performed and the maximum force output (N) is normalized to body mass (N/kg).
|
Baseline (5 days post PRP injection), Week 6, Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quadriceps femoris isometric strength (N/kg), affected side
Time Frame: Baseline (5 days post PRP injection), Week 6, Week 12
|
Maximum isometric quadriceps strength measured with a hand-held dynamometer in sitting position (hip 90° flexion, knee semi-flexion), with the dynamometer placed on the anterior surface of the ankle.
Three maximal trials (5 seconds each) are performed and the maximum force output (N) is normalized to body mass (N/kg).
|
Baseline (5 days post PRP injection), Week 6, Week 12
|
|
Hamstring isometric strength (N/kg), affected side
Time Frame: Baseline (5 days post PRP injection), Week 6, Week 12
|
Maximum isometric hamstring strength measured with a hand-held dynamometer in prone position (hip neutral, knee flexion 90°), with the dynamometer placed on the proximal posterior surface of the ankle.
Three maximal trials (5 seconds each) are performed and the maximum force output (N) is normalized to body mass (N/kg).
|
Baseline (5 days post PRP injection), Week 6, Week 12
|
|
Knee pain during activity (Visual Analog Scale, 0-10)
Time Frame: Baseline (5 days post PRP injection), Week 6, Week 12
|
Pain severity during activity assessed using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
|
Baseline (5 days post PRP injection), Week 6, Week 12
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength symmetry indices (QI, HI, HipI), %
Time Frame: Baseline (5 days post PRP injection), Week 6, Week 12
|
Strength symmetry indices calculated as (affected side isometric strength / unaffected side isometric strength) × 100 for HipSIT (HipI), quadriceps (QI), and hamstrings (HI).
|
Baseline (5 days post PRP injection), Week 6, Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 8, 2025
Primary Completion (Actual)
December 12, 2025
Study Completion (Actual)
December 13, 2025
Study Registration Dates
First Submitted
December 13, 2025
First Submitted That Met QC Criteria
December 13, 2025
First Posted (Actual)
December 29, 2025
Study Record Updates
Last Update Posted (Actual)
December 29, 2025
Last Update Submitted That Met QC Criteria
December 13, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FU_MGBeydagi_PRP_B_2025/12/150
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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