NCT07329010

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

December 2, 2025

Last Update Submit

May 3, 2026

Conditions

Keywords

Whey ProteinExercisePreoperative NutritionTotal Hip Arthroplasty (THA)Elderly PatientsPostoperative RecoveryFunctional Outcomes

Outcome Measures

Primary Outcomes (2)

  • Serum Albumin Level

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

    5 days

  • C-Reactive Protein (CRP) Level

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

    5 days

Secondary Outcomes (3)

  • Time to Mobilization

    5 days

  • Length of Hospital Stay

    5 days

  • Physical and Social Functioning

    5 days

Study Arms (2)

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

Dietary Supplement: Preoperative Whey Protein and Exercise Program

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.

Interventions

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

Also known as: Dietary Supplement + Behavioral (Exercise)
Intervention Group: "Preoperative Whey Protein Supplementation and Exercise Program

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes unıversity

Kayseri, Talas, 38260, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Dietary SupplementsExercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study. Neither participants nor investigators are blinded to group assignments.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 2, 2025

First Posted

January 9, 2026

Study Start

September 25, 2025

Primary Completion

January 15, 2026

Study Completion

April 30, 2026

Last Updated

May 5, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations