- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07329010
Effects of Preoperative Whey Protein and Exercise Support on Recovery After Total Hip Arthroplasty (THA)
The Effect of Preoperative Whey Protein and Physical Exercise Support on Recovery After Total Hip Arthroplasty
Objective:
The aim of this project is to evaluate the effects of preoperative whey protein supplementation and a physical exercise program on postoperative recovery outcomes in patients undergoing total hip arthroplasty (THA). Specifically, inflammatory markers (CRP), nutritional status (albumin), mobilization time, length of hospital stay, and physical and social functioning will be assessed. As one of the first randomized controlled trials in Turkey to focus on the preoperative period and to evaluate a combined nutrition and exercise intervention in elderly surgical patients, this study holds pioneering significance in both clinical and academic contexts.
Methods:
This study is designed as a randomized controlled trial. The intervention group will receive whey protein supplementation and a home-based exercise program for 14 days preoperatively, while the control group will receive standard preoperative care. Data collection will be performed preoperatively and on postoperative days 3 and 5, focusing on metabolic and functional parameters.
Expected Outcomes:
The findings of this study are expected to contribute to the improvement of patient care through a multidisciplinary approach, inform health policy development, and provide a foundation for larger-scale clinical research in Turkey.
Study Overview
Status
Intervention / Treatment
Detailed Description
Background:
Hip osteoarthritis (HOA) is a common degenerative disease in older adults that leads to pain, deformity, and functional loss, thereby reducing quality of life. Muscle atrophy, neuromuscular dysfunction, and pain are frequently observed in the affected limb, resulting in decreased muscle strength. Gait analyses have shown reduced hip range of motion (ROM), decreased walking speed, and diminished hip flexion and abduction moments.
Total hip arthroplasty (THA), widely used in the treatment of HOA, is also performed for femoral fractures, arthritis, developmental hip dysplasia, and osteonecrosis. Although THA is an effective surgical method, delayed wound healing, infection risk, muscle weakness, and mobilization limitations remain important postoperative challenges. With postoperative pain reduction, hip function and quality of life improve significantly. However, diminished proprioception may cause balance problems, increasing the risk of falls.
Exercise therapy plays a key role in postoperative rehabilitation after THA. Physiotherapists provide gait training, ROM exercises, and balance activities. Exercise therapy reduces pain and increases physical activity levels. Systematic reviews have demonstrated the positive effects of exercise on muscle strength and gait performance following THA.
Nevertheless, delayed wound healing, infection, increased morbidity and mortality, and prolonged hospitalization may still occur after THA. In this context, preoperative nutritional support plays a critical role in improving patient outcomes. Protein-based supplements can support muscle protein synthesis and accelerate recovery. Increased protein intake helps prevent muscle breakdown and supports recovery. Thus, selecting an appropriate nutritional and exercise strategy is essential in the postoperative management of orthopedic patients.
Whey protein (WP) is a protein source rich in branched-chain amino acids (BCAAs) and essential amino acids, with high bioavailability and easy digestibility. WP has been shown to stimulate muscle protein synthesis, enhance recovery, and reduce postoperative infection risk.
In Turkey, the surgical needs of the elderly population are steadily increasing, and THA procedures are becoming a major healthcare requirement, especially in older age groups. While the separate effects of exercise and protein supplementation on postoperative outcomes have been demonstrated, there is no study in Turkey evaluating the combined impact of these two interventions when applied in the preoperative period.
This project aims to be the first randomized controlled trial in elderly THA patients to investigate the effects of oral whey protein supplementation combined with a preoperative exercise program on metabolic markers, early mobilization, and length of hospital stay. Both interventions are safe, cost-effective, and easy to apply, and they allow elderly patients to continue daily activities without additional effort or time burden. This project is expected to contribute significantly to the literature by offering an innovative approach in postoperative THA management and by generating scientific evidence on the interaction between nutrition, exercise, and surgical outcomes. The study will be conducted under the supervision of an experienced orthopedic surgeon, with methodological and practical support from clinical dietitians and physiotherapists. The intervention design, data collection, and analysis procedures are planned in accordance with the literature and scientific standards.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Talas
-
Kayseri, Talas, Turkey (Türkiye), 38260
- Erciyes unıversity
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 50 and 70 years
- Scheduled for elective total hip arthroplasty (THA)
- Able to participate in the preoperative intervention for at least 2 weeks
- Conscious and able to communicate
Exclusion Criteria:
- Patients with advanced malnutrition
- Patients with active cancer, malabsorption, liver or kidney failure
- Patients with severe cognitive impairment
- Patients with health conditions that prevent participation in exercise
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group: "Preoperative Whey Protein Supplementation and Exercise Program
The preoperative exercise and protein supplementation program will be conducted by patients in their home environment.
Patients will be enrolled in the study 14 days prior to the scheduled surgery.
At the start of the program, all patients will receive face-to-face instructions, and data will be collected under the supervision of an experienced orthopedic surgeon at the hospital
|
The intervention group will receive 14 days of preoperative whey protein supplementation combined with a home-based exercise program.
Patients will receive face-to-face instructions at program initiation, and data will be collected under the supervision of an experienced orthopedic surgeon
Other Names:
|
|
No Intervention: Control Group: "Standard Preoperative Care"
Patients in the control group will receive only the hospital's standard preoperative care protocol. This care includes: Daily monitoring of vital signs Preoperative laboratory tests Anesthesia pre-assessment Surgical information and counseling Medication management No additional protein supplementation or exercise training will be provided specifically to this group. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum Albumin Level
Time Frame: 5 days
|
Postoperative serum albumin levels measured on days 3 and 5 after total hip arthroplasty.
|
5 days
|
|
C-Reactive Protein (CRP) Level
Time Frame: 5 days
|
Postoperative serum CRP levels measured on days 3 and 5 after total hip arthroplasty.
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Mobilization
Time Frame: 5 days
|
Time (in hours) from surgery completion to first independent mobilization.
|
5 days
|
|
Length of Hospital Stay
Time Frame: 5 days
|
Total duration of hospital stay (in days) after surgery.
|
5 days
|
|
Physical and Social Functioning
Time Frame: 5 days
|
Assessment of patients' physical and social functioning using standardized scales.
|
5 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 010203
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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