Progressive Resistance Training Compared to Neuromuscular Exercise in Patients With Hip Osteoarthritis
- Conditions
- Hip Osteoarthritis
- Interventions
- Other: Neuromuscular exercise and booster sessionsOther: Progressive Resistance Training and no booster sessionsOther: Progressive Resistance Training and booster sessionsOther: Neuromuscular exercise and no booster sessions
- Registration Number
- NCT04714047
- Lead Sponsor
- University of Aarhus
- Brief Summary
The primary aim of this randomized controlled trial is to investigate the effectiveness of 12 weeks of progressive resistance training (PRT) compared to neuromuscular exercise (NEMEX) on functional performance in patients with hip OA measured by the 30-seconds chair stand test. Secondary aims are to investigate; the determinants of improvement in physical function following PRT or NEMEX; the effectiveness of booster sessions in prolonging the effects of the initial interventions (12 months), the cost-effectiveness of booster sessions (12 months). We will test the hypothesis that PRT is superior to NEMEX in improving physical function measured with the 30s sit-to-stand test at 12 week follow-up.
- Detailed Description
This randomized controlled trial will be a multicenter trial involving hospitals and physiotherapy clinics across Denmark. Part 1: For the initial 12-week exercise intervention, participants will be randomized into two groups: PRT or NEMEX. Part 2: After the initial intervention, participants in each group will be randomized to booster sessions (PRT+B and NEMEX+B) or to receive no further treatment (PRT-B and NEMEX-B). Booster sessions will be provided at 4, 6, 8 and 10 months after baseline. Outcomes will be measured at baseline, after 12 weeks of intervention, and at 6-, 9- and 12-months follow-up.
The exercise interventions will be performed at the collaborating hospitals and physiotherapy clinics across Denmark. All sessions will be conducted in group sessions with one physiotherapist supervising the exercises. The duration and frequency of the interventions will be 12 weeks with 2 supervised sessions each week. If participants experience pain during exercise exceeding 5 out of 10 on a Visual Analogue Scale (VAS), the physiotherapist will modify the exercise, decreasing the exercise intensity (load) or modifying the range of motion. All unilateral exercises will be performed for both sides.
The NEMEX intervention will follow the NEMEX program as described by Ageberg et al. The sessions consist of a 10-minute submaximal warm up on an exercise bike followed by 50 minutes of NEMEX training with exercises focused on stability, postural function, postural orientation, lower extremity muscle strength, and functional exercises.
The PRT intervention will follow the same protocol for training frequency and duration as the NEMEX intervention. The sessions consist of a 10-minute submaximal warm up on an exercise bike followed by 50 minutes of PRT with exercises targeting the muscles of the hip and knee joints; leg press, hip extension, hip abduction, hip flexion and knee extension.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- Clinically diagnosed OA of the hip joint according to the National Institute for Health and Care Excellence criteria
- Have experienced pain of at least 3 out of 10 on the visual analog scale in the index hip within the last two weeks
- Age ≥ 45 years
- No surgery in the lower extremities six months prior to inclusion
- No comorbidity that prevents exercising
- Adequacy in written and spoken Danish
- Not being a candidate for total hip arthroplasty
- BMI score > 40
- Pregnancy
- Resistance training or neuromuscular training for the lower extremities for more than 12 sessions in the last 6 months or 6 sessions in the last 3 months (resistance training is defined by the American College of Sports Medicine guidelines while neuromuscular training is defined by exercises involving multiple joints and muscle groups performed in functional weight-bearing positions with emphasis on the quality and efficiency of movement, as well as alignment of the trunk and lower limb joints)
- Planned vacation for more than 14 days within the 12-week intervention period without the possibility of expanding the intervention accordingly
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 4: Neuromuscular exercise and booster sessions NEMEX + Booster sessions Group 1: Progressive Resistance Training and no booster sessions PRT Group 2: Progressive Resistance Training and booster sessions PRT + Booster sessions Group 3: Neuromuscular exercise and no booster sessions NEMEX
- Primary Outcome Measures
Name Time Method Change in functional performance measured by the 30-seconds chair stand test Measured at baseline, 12 week and 12 month follow-up. The 30-second chair stand test is a valid and responsive measure of lower-extremity muscle strength evaluating sit-to-stand function, which is limited in people with lower extremity OA.
- Secondary Outcome Measures
Name Time Method Change in 40m fast-paced walk test Measured at baseline, 12 week and 12 month follow-up. Time (in seconds) taken to complete a 40 m course at fast walking pace.
Change in the HOOS activities of daily living (ADL) function subscale Measured at baseline, 12 week and 12 month follow-up. The HOOS ADL function subscale is a 17-item patient-reported outcome measure designed to assess ADL function in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better ADL function status.
Change in the HOOS sports and recreation subscale Measured at baseline, 12 week and 12 month follow-up. The HOOS sports and recreation subscale is a four-item patient-reported outcome measure designed to assess sports and recreation function in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better sports and recreation status.
Change in the HOOS symptoms subscale Measured at baseline, 12 week and 12 month follow-up. The HOOS symptoms subscale is a five-item patient-reported outcome measure designed to assess hip symptoms in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better symptoms status.
Global Perceived Effect (GPE) Measured at 12 week and 12 month follow-up. The GPE of the interventions will be assessed for three domains on a 7-point Likert scale
Change in the HOOS pain subscale Measured at baseline, 12 week and 12 month follow-up. The HOOS pain subscale is a 10-item patient-reported outcome measure designed to assess other hip symptoms in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better symptoms status.
Change in the HOOS quality-of-life subscale Measured at baseline, 12 week and 12 month follow-up. The HOOS quality-of-life subscale is a four-item patient-reported outcome measure designed to assess hip-related quality-of-life in patients with hip osteoarthritis. The total score ranges from 0 to 100, with higher scores indicating better quality-of-life status.
Adherence to the 12 week initial intervention Registered throughout the 12 week initial intervention. High adherence is defined as ≥ 80% attendance to the supervised interventions.
Change in leg extension muscle power (watt/kg bodyweight) Measured at baseline, 12 week and 12 month follow-up. Leg extensor muscle power (force times acceleration) will be measured using the Nottingham Power Rig (NPR). The NPR measures the power output in total watt and watt pr. bodyweight in kilograms from a seated push on a flat pedal which is transmitted by a lever and chain to spin a flywheel. The NPR is a safe and reliable method to measure explosive knee extensor muscle power and has been validated as a clinically important measure of muscle function in elderly individuals.
Change in 9 step stair climb test Measured at baseline, 12 week and 12 month follow-up. Time (in seconds) taken to negotiate 9 steps on a standard step-height stair-way (up and down).
Adherence to the 9 months of self-administered training Registered throughout the 9 months follow-up period. High adherence is defined by ≥ 80% of the assigned exercise programs performed at home or at the fitness center.
AE (Adverse Events) & Serious Adverse Events (SAE) Registered throughout the 12 month study period. Continous registration of health issues and injuries. Physiotherapists in charge of the training sessions will monitor potential AE and SAE. Also, during the follow-up visits at week 12 and 12 months, the participants will be asked about potential AE's and SAE's using open-probe questions.
Drop-outs Registered throughout the 12 month study period. Number og drop-out from the training interventions.
Change in muscle strength Measured at baseline, 12 week and 12 month follow-up. Muscle strength is measured in a standardized one-repetition maximum test for the leg press exercise.
Trial Locations
- Locations (3)
Aarhus University Hospital
🇩🇰Aarhus N, Denmark
Aarhus University
🇩🇰Aarhus, Denmark
Næstved-Slagelse-Ringsted Hospitals
🇩🇰Slagelse, Denmark