Prehabilitation in Older People Undergoing Total Hip Replacement
NCT07048080 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2025-07-02
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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