PREHIP
(P)Rehabilitation in Older People With Osteoarthritis Undergoing Total Hip Replacement : From Physicological Mechanism to Clinical Benefits
Sponsor study identifier
interventional
70
1 country
1
Study Start
August 2, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to determine the effect of Resistance Exercise Training (RET)-based (p)rehabilitation versus usual care on skeletal muscle mass and function, as well as on underlying biological processes, in older adults undergoing elective Total Hip Replacement (THR) due to severe Osteoarthritis (OA). The main questions it aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 17, 2025
Actual (reported)July 2, 2025
Actual (reported)August 2, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Cross-Sectional Area of Quadriceps measured via MRI - Scanning after resistance exercise training
Anatomic CSA of the quadriceps muscle will be assessed in the study by MRI scanning at baseline, after 2 weeks of prehabilitation and after 12 weeks of rehabilitation for all participants. On the obtained MRI images, muscle tissue will be defined by threshold values of 0-100 Hounsfield Units, and the quadriceps muscle will be selected by manual tracing using ImageJ software (version 1.45d, National Institute of Health, Maryland, USA). All analyses will be performed by one investigator blinded to participant coding.
The assessment will be conducted 2 weeks and 48 hours before surgery and after the 12-week intervention in both groups
Change in Protein Synthesis Rates (MPS) on Muscle, Bone and Cartilage measured via tissue samples after resistance exercise training.
All tissue samples (muscle, cartilage and bone) will be collected through surgical excision in the sub-study, except for the vastus lateralis muscle which will be collected from the middle region of the vastus lateralis during the surgical procedure. Conventional muscle biopsy samples of the vastus lateralis will be collected to assess MPS rates and compare this between the intervention and usual care group, as well as to provide a reference to the synthesis rates of the various musculoskeletal tissues obtained during surgery. Hereafter, samples will be freed from any visible blood, immediately frozen in liquid nitrogen, and will be stored at -80°C until subsequent analysis (38). Intramuscular free and bound 2H-Alanine enrichment will be analyzed by gas-chromatography mass spectrometer (GC-MS; Agilent 5975C MSD \& 7890A GC, Wilmington, DE).
The assessment will be conducted 2 weeks before surgery and during the surgery.
Change in functional capacity measured via Short Physical Performance Battery (SPPB) after resistance exercise training.
The assessment will be conducted 2 weeks and 48 hours before surgery and after the 12-week intervention.
Immunodetection of protein synthesis markers in tissue sample 2 weeks before surgery, during surgery and after resistance exercise training.
The assessments will be conducted with the samples obtained 2 weeks before surgery, during surgery and after 12-week intervention.
Change in biomarkers measured via blood samples after resistance exercise training.
The assessment will be conducted 2 weeks and 48 hours before surgery and after the 12-week intervention.
Change in functional capacity measured via Timed Up and Go test (TUG) after resistance exercise training.
The assessment will be conducted 2 weeks and 48 hours before and after the 12-week intervention
Change in muscle strength measured via 1RM strength tests after resistance exercise training.
The assessment will be conducted 2 weeks and 48 hours before surgery and after the 12-week intervention
Participants assigned to the (p)rehabilitation group will perform a supervised Progressive Resistance Exercise Training 2 week program for the whole body three times per week before total hip replacement surgery and for 12 weeks after. In a sub-study, the first 10 participants of (P)rehabilitation group will be included to study the effects of 2 weeks prehabilitation on tissue protein synthesis rates. A two-week deuterium oxide (2H2O or 'heavy water') loading protocol will be conducted during the two week before THR surgery to assess diurnal rates of musculoskeletal protein synthesis.
Participants assigned to the control group will receive the usual therapy, medical monitoring, and educational lectures after surgery. No intervention is planned before total hip replacement surgery. In a sub-study, the first 10 participants of Usual Care group will be included to study the effects of 2 weeks prehabilitation on tissue protein synthesis rates. A two-week deuterium oxide (2H2O or 'heavy water') loading protocol will be conducted during the two week before THR surgery to assess diurnal rates of musculoskeletal protein synthesis.
The (p)rehabilitation intervention program will be based on supervised whole-body RET performed 3 times/week before (2-week) and up to 12 weeks after surgery, with one day in-between sessions. Training will consist of a 10-min warm-up, followed by one warm-up and 4 sets on leg press, leg-extension and leg abductor machines. Upper body exercises (chest press, lat pulldown and horizontal row will be performed with 2 sets of each exercise. During the 2-week training before surgery, the workload will be increased from 70% (week 1) to 80% (week 2) of 1RM (10 repetitions in each set). After surgery, the workload will be increasing from 50% of 1RM to 80% from the last 6 weeks. All the participants included in the per-protocol analysis must complete at least 80% of the training sessions. We will take into consideration the mobility precautions so as not to dislocate the prosthesis (avoid hip flexion of 90 degrees and more; do not perform adduction exercises and hip rotations).
Universidad de La Frontera
Temuco, Cautin, 4780000, Chile
First Submitted
June 17, 2025
First Posted
July 2, 2025
Study Start
August 2, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
In a sub-study, the first 10 participants of the (P)rehabilitation group will be included to study the effects of 2 weeks prehabilitation on tissue protein synthesis rates. A two-week deuterium oxide (2H2O or 'heavy water') loading protocol will be conducted during the two week before THR surgery to assess diurnal rates of musculoskeletal protein synthesis. This 2H2O method enables the assessment of muscle, cartilage and bone tissue protein synthesis rates when tissue samples are collected after the 2 weeks of prehabilitation.
In a sub-study, the first 10 participants of the Usual Care group will be included to study the effects of 2 weeks prehabilitation on tissue protein synthesis rates. A two-week deuterium oxide (2H2O or 'heavy water') loading protocol will be conducted during the two week before THR surgery to assess diurnal rates of musculoskeletal protein synthesis. This 2H2O method enables the assessment of muscle, cartilage and bone tissue protein synthesis rates when tissue samples are collected after the 2 weeks of usual care.
Participants assigned to the usual care group will receive the usual therapy, medical monitoring, and educational lectures after surgery. No intervention is planned before total hip replacement surgery. The patient is hospitalized for surgery. At hospital discharge, the usual care group will start with standard rehabilitation (sessions: 1st month, 2-3x/week, 2nd month 1-2x/week and 3rd month 1x/month) based on mobility and strength exercises without using progressive RET with machines until 3 months after surgery.
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Primary Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 12, 2026
Record last verified: 2026-06
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