Prehabilitation in Older People Undergoing Total Hip Replacement

NCT07048080 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-07-02

No results posted yet for this study

Summary

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:

* What is the effects of RET-based (p)rehabilitation versus usual care to improve muscle mass and function in patients undergoing elective unilateral THR surgery for end-stage OA?
* What is the potential of certain circulating biomarkers to predict the efficacy of the musculoskeletal system response to RET in patients with severe OA? Researchers will compare RET-based (p)rehabilitation versus usual care to see if RET works to increase skeletal muscle mass and function.

Participants in the usual care group will undergo standard rehabilitation (12 weeks post-surgery), and participants in the (p)rehabilitation group will undergo RET-based full-body (p)rehabilitation (3x/week) for 2 weeks pre-surgery and 12 weeks post-surgery.

Conditions

  • Hip Replacement in Osteoarthritis Patients
  • Osteoarthritis, Hip

Interventions

BEHAVIORAL

(P)rehabilitation Progresive Resistance Exercise Training

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).

BIOLOGICAL

Prehabilitation Group Deuterated Water

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.

BIOLOGICAL

Usual Care Group Deuterated Water

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.

OTHER

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.

Sponsors & Collaborators

  • Universidad de La Frontera

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2028-12-31
Completion
2029-03-31

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07048080 on ClinicalTrials.gov