Clinical trial NCT04061993: Effects of Early Home-based Strength and Sensory-motor Training After THA on Functional Outcome and Patient Satisfaction
Official title: Effects of Early Home-based Strength and Sensory-motor Training After Total Hip Arthroplasty: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty
Replacement
Hip
Strength Training
Keywords: Total hip arthroplasty
Early postoperative exercise
Home-based training
Lead sponsor: Valdoltra Orthopedic Hospital
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A prospective multicentre randomised clinical trial of 250 selected patients with THA, who will be randomly assigned to intervention (IG) or control group (CG). Both will have standard physiotherapy during hospitalisation, IG will additionally learn strength and sensory-motor training exercises. Follow up will be performed with physical tests, maximal voluntary isometric contractions and outcome assessment questionnaires at baseline and 1, 3 and 12 months after surgery.

Detailed description: This study is a prospective multicentre randomised clinical trial to be conducted in orthopaedic departments of two Slovenian hospitals. In each hospital 125 patients aged 60 or older with unilateral osteoarthritis, ASA score 1-3, signed informed consent, access to watching USB videos and without terminal illnesses disabling rehabilitation participation, will be randomly assigned to intervention (IG) or control group (CG). Total hip arthroplasty with anterior approach will be performed. All patients will get current standard physiotherapy during hospitalisation. Patients in IG will additionally learn strength and sensory-motor training exercises. Patients in both groups will get USB drives with exercise videos, written exercise instructions and training diary. Physiotherapists will perform measurements (physical tests and maximal voluntary isometric contractions) and patients will fill in outcome assessment questionnaires (Harris Hip Score and 36-Item Short Form Health Survey) at baseline and 1, 3 and 12 months after surgery.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing elective primary unilateral THA for OA.
2. Patients older than 60 years at the time of surgery.
3. Ability to watch exercise videos on USB drive.
4. American Society of Anaesthesiologists (ASA) Classification 1-3.
5. Patients are able to consent and willing to comply with the study protocol.

Exclusion Criteria:

1. Primary THA for a diagnosis other than OA (aseptic femoral head necrosis, dysplastic hip...) or revision THA.
2. Patients having previous hip interventions (osteosynthesis, osteotomy...)
3. Discharge to rehabilitation units or nursing homes.
4. Patients unable to consent and comply with the study protocol (diagnosed with dementia, mental disorders, poor preoperative physical status - neurological disorders, amputations, trouble walking with walkers or wheelchairs, painful hip or knee prosthesis in other joints).

Primary outcomes:
measure: Change in isometric hip and trunk muscles strength
timeFrame: Baseline (before surgery), 1, 3 and 12 months after surgery
measure: Change in 8UG
timeFrame: Baseline (before surgery), 1, 3 and 12 months after surgery
measure: Change in 10MW
timeFrame: Baseline (before surgery), 1, 3 and 12 months after surgery
Secondary outcomes:
measure: HHS
timeFrame: Baseline (before surgery), 1, 3 and 12 months after surgery
measure: SF-36_v2
timeFrame: Baseline (before surgery), 3 and 12 months after surgery
Other outcomes:
measure: Training compliance
timeFrame: First 3 months after surgery
Locations:
city: Ankaran
country: Slovenia
facility: Valdoltra Orthopaedic Hospital
city: Novo Mesto
country: Slovenia
facility: General Hospital Novo mesto
Study officials:
References:
citation: Kristof Mirt P, Strojnik V, Kavcic G, Trebse R. Effects of early home-based strength and sensory-motor training after total hip arthroplasty: study protocol for a multicenter randomized controlled trial. Trials. 2022 Nov 8;23(1):929. doi: 10.1186/s13063-022-06779-8.