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临床试验/NCT07329010
NCT07329010已完成不适用

The Effect of Preoperative Whey Protein and Physical Exercise Support on Recovery After Total Hip Arthroplasty

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年9月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
Serum Albumin Level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

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

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Intervention Group: "Preoperative Whey Protein Supplementation and Exercise Program

Experimental

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

干预措施: Preoperative Whey Protein and Exercise Program (Dietary Supplement)

Control Group: "Standard Preoperative Care"

No Intervention

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.

结局指标

主要结局

Serum Albumin Level

时间窗: 5 days

Postoperative serum albumin levels measured on days 3 and 5 after total hip arthroplasty.

C-Reactive Protein (CRP) Level

时间窗: 5 days

Postoperative serum CRP levels measured on days 3 and 5 after total hip arthroplasty.

次要结局

  • Time to Mobilization(5 days)
  • Length of Hospital Stay(5 days)
  • Physical and Social Functioning(5 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

HÜMEYRA YÜKSEL

Principal Investigator

TC Erciyes University

研究点 (1)

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