ArthoplastyTHANCT07329010
Effects of Preoperative Whey Protein and Exercise Support on Recovery After Total Hip Arthroplasty
A study testing Preoperative Whey Protein and Exercise Program in people with Arthoplasty and Nutrition, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Arthoplasty, Nutrition, Geriatric Assessment
- What is being tested?
- Preoperative Whey Protein and Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Arthoplasty, Nutrition, Geriatric Assessment, Exercise Training, Preoperative
- Being tested
- Preoperative Whey Protein and Exercise Program
- Keywords
- Whey Protein, Exercise, Preoperative Nutrition, Total Hip Arthroplasty (THA), Elderly Patients, Postoperative Recovery, Functional Outcomes
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Whey Protein and Exercise ProgramDietary supplement
Also called Dietary Supplement + Behavioral (Exercise)
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Albumin Level
Postoperative serum albumin levels measured on days 3 and 5 after total hip arthroplasty.
Measured: 5 days
C-Reactive Protein (CRP) Level
Postoperative serum CRP levels measured on days 3 and 5 after total hip arthroplasty.
Measured: 5 days
Secondary outcomes (3)
Time to Mobilization
Time (in hours) from surgery completion to first independent mobilization.
Measured: 5 days
Length of Hospital Stay
Total duration of hospital stay (in days) after surgery.
Measured: 5 days
Physical and Social Functioning
Assessment of patients' physical and social functioning using standardized scales.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start25 Sep 2025
- Primary completion15 Jan 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthoplastyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HÜMEYRA YÜKSEL, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329010
- Sponsor's protocol ID
- 010203
- Acronym
- THA
- Status last verified
- May 2026
- First submitted
- 2 Dec 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38349251
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Whey Protein and Physical Exercise Support on Recovery After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT07329010
- Acronym / sponsor ID
- THA / 010203
- Conditions
- Arthoplasty, Nutrition, Geriatric Assessment, Exercise Training, Preoperative
- Keywords
- Whey Protein, Exercise, Preoperative Nutrition, Total Hip Arthroplasty (THA), Elderly Patients, Postoperative Recovery, Functional Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: "Preoperative Whey Protein Supplementation and Exercise Program | Experimental | Dietary Supplement: Preoperative Whey Protein and Exercise ProgramThe 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 |
| 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Whey Protein and Exercise ProgramAlso: Dietary Supplement + Behavioral (Exercise)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 | Dietary supplement | Intervention Group: "Preoperative Whey Protein Supplementation and Exercise Program |
Primary outcome
Serum Albumin Level
Time frame: 5 days
Postoperative serum albumin levels measured on days 3 and 5 after total hip arthroplasty.
C-Reactive Protein (CRP) Level
Time frame: 5 days
Postoperative serum CRP levels measured on days 3 and 5 after total hip arthroplasty.
3 secondary outcomes
Time to Mobilization
Time frame: 5 days
Length of Hospital Stay
Time frame: 5 days
Physical and Social Functioning
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Results publication: PubMed 38349251Adebero 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Whey Protein and Exercise Program in people with Arthoplasty and Nutrition, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Albumin Level (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07329010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.