Prehabilitation in Older People Undergoing Total Hip Replacement
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversidad de La Frontera
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals aged from 60 y and over.
18.5 < BMI < 40 kg/m2.
Individuals on waiting list to undergo a unilateral elective surgery for Total Hip Replacement due to primary severe Osteoarthritis.
Disqualifiers
Individuals with severe OA in the contralateral hip.
Individuals who has been performing regular RET (2 or more times per week) in the previous 6 months.
Individuals who smoke.
Significant psychiatric or neurological disorders, with the use of acetylcholinesterase inhibitors, and untreated mood disorders or depressive pathology.
Trial design
Design model
Parallel
Treatments tested in this trial
(P)rehabilitation Progresive Resistance Exercise Training
BehavioralThe (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).
Prehabilitation Group Deuterated Water
Biological/VaccineIn 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.
Usual Care Group Deuterated Water
Biological/VaccineIn 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.
Usual Care
Other interventionParticipants 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: (P)rehabilitation GroupExperimental treatment 2 interventions
Group B: Usual Care GroupOther 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
The assessment will be conducted 2 weeks and 48 hours before surgery and after the 12-week intervention in both groups2
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).
Time frame
The assessment will be conducted 2 weeks before surgery and during the surgery.Secondary outcomes
1
Change in functional capacity measured via Short Physical Performance Battery (SPPB) after resistance exercise training.
The functional capacity is assessed through the Short Physical Performance Battery (SPPB).
Time frame
The assessment will be conducted 2 weeks and 48 hours before surgery and after the 12-week intervention.2
Immunodetection of protein synthesis markers in tissue sample 2 weeks before surgery, during surgery and after resistance exercise training.
Muscle biopsies will be obtained from the middle region of the vastus lateralis muscle. In short, skin and muscle fascia will be locally anesthetized using 1% xylocaine (except during surgery as patient is already anesthesized). After 10 minutes a small incision will be made in skin and fascia after which the biopsy needle will be introduced in the muscle to obtain small muscle samples (total ± 150 mg). Biopsy samples from all tissues will be used to perform Western Blot and PCR analyses. Specifically, (phosphorylated) protein and mRNA expression of several proteins/genes from protein synthesis (Akt, mTOR, S6(K), 4E-BP1) and degradation (MAFbx, MuRF1) pathways will be assessed according to standard procedures. In addition, potential fiber type-specific alterations in muscle fiber size, myonuclear and/or satellite cell content will be assessed using routine immunohistochemistry in participants from whom a muscle biopsy was obtained before and after surgery.
Time frame
The assessments will be conducted with the samples obtained 2 weeks before surgery, during surgery and after 12-week intervention.3
Change in biomarkers measured via blood samples after resistance exercise training.
Blood samples will be taken to obtain plasma and serum in 6 mL tubes. Then, the samples will be centrifuged at 2500 rpm × 15 min. The plasma and serum will be distributed in microtubes and stored in a freezer at -80 °C until the evaluation by ELISA of the biomarkers (Cartilage remodeling: CTX-II and COMP; Bone remodeling: CTX-I and OC, and Muscle mass: PIIINP and SI) using Human Kits following the manufacturer's recommendations.
Time frame
The assessment will be conducted 2 weeks and 48 hours before surgery and after the 12-week intervention.4
Change in functional capacity measured via Timed Up and Go test (TUG) after resistance exercise training.
The functional capacity is assessed through the adapted Timed Up and Go test (TUG).
Time frame
The assessment will be conducted 2 weeks and 48 hours before and after the 12-week interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: