Effects of Early Home-based Strength and Sensory-motor Training After THA on Functional Outcome and Patient Satisfaction

Valdoltra Orthopedic Hospital

Status: Completed

Conditions: Arthroplasty; Replacement; Hip; Strength Training

Treatments: Procedure: Strength and Sensory-Motor Training; Procedure: Current Standard Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04061993

PRT_PhD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 4 patient groups

Intervention Group OBV

Experimental group

Description:

Intervention Group in Valdoltra Orthopaedic Hospital. Patients will get current standard physiotherapy during hospitalisation and extra one-on-one training to learn strength and sensory-motor exercises. At discharge they will get USB drives with exercise videos, written exercise instructions, training diary and exercise aids for strength and sensory-motor training.

Treatment:

Procedure: Strength and Sensory-Motor Training

Procedure: Current Standard Physiotherapy

Control Group OBV

Active Comparator group

Description:

Control Group in Valdoltra Orthopaedic Hospital. Patients will get current standard physiotherapy during hospitalisation and USB drives with exercise videos, written exercise instructions and training diary at discharge.

Treatment:

Procedure: Current Standard Physiotherapy

Intervention Group SBNM

Experimental group

Description:

Intervention Group in General Hospital Novo mesto. Patients will get current standard physiotherapy during hospitalisation and extra one-on-one training to learn strength and sensory-motor exercises. At discharge they will get USB drives with exercise videos, written exercise instructions, training diary and exercise aids for strength and sensory-motor training.

Treatment:

Procedure: Strength and Sensory-Motor Training

Procedure: Current Standard Physiotherapy

Control Group SBNM

Active Comparator group

Description:

Control Group in General Hospital Novo mesto. Patients will get current standard physiotherapy during hospitalisation and USB drives with exercise videos, written exercise instructions and training diary at discharge.

Treatment:

Procedure: Current Standard Physiotherapy