Effects of Preoperative Whey Protein and Exercise Support on Recovery After Total Hip Arthroplasty

NCT ID: NCT07329010

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-05-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Arthoplasty Nutrition Geriatric Assessment Exercise Training Preoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomly assigned to either the intervention group, which receives 14 days of preoperative whey protein supplementation combined with a home-based exercise program, or the control group, which receives standard preoperative care. Both groups are followed for metabolic and functional outcomes on postoperative days 3 and 5
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

This is an open-label study. Neither participants nor investigators are blinded to group assignments.

Study Groups

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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

Group Type EXPERIMENTAL

Preoperative Whey Protein and Exercise Program

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Preoperative Whey Protein and Exercise Program

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Dietary Supplement + Behavioral (Exercise)

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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HÜMEYRA YÜKSEL

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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HÜMEYRA YÜKSEL, Msc

Role: CONTACT

+905538748327

References

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Adebero T, Omana H, Somerville L, Lanting B, Hunter SW. Effectiveness of prehabilitation on outcomes following total knee and hip arthroplasty for osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. Disabil Rehabil. 2024 Dec;46(24):5771-5790. doi: 10.1080/09638288.2024.2313128. Epub 2024 Feb 13.

Reference Type RESULT
PMID: 38349251 (View on PubMed)

Other Identifiers

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010203

Identifier Type: -

Identifier Source: org_study_id

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