Clinical trial NCT04714047: Progressive Resistance Training Compared to Neuromuscular Exercise in Patients With Hip Osteoarthritis
Official title: Progressive Resistance Training Compared to Neuromuscular Exercise in Patients With Hip Osteoarthritis, and the Additive Effect of Booster Sessions: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: Progressive Resistance Training
Neuromuscular Exercise
Physical Therapy
Physical Rehabilitation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Vejle Hospital
name: Naestved Hospital
name: Regional Hospital Holstebro
name: Aarhus University Hospital
name: Physiotherapy Associates
name: Slagelse Hospital
name: University of Southern Denmark
name: Regionshospitalet Silkeborg
First posted: 2021-01-19
Enrollment: 160
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in functional performance measured by the 30-seconds chair stand test
timeFrame: Measured at baseline, 12 week and 12 month follow-up.
Secondary outcomes:
measure: Change in 40m fast-paced walk test
timeFrame: Measured at baseline, 12 week and 12 month follow-up.
measure: Change in 9 step stair climb test
timeFrame: Measured at baseline, 12 week and 12 month follow-up.
measure: Change in leg extension muscle power (watt/kg bodyweight)
timeFrame: Measured at baseline, 12 week and 12 month follow-up.
measure: Change in the HOOS pain subscale
timeFrame: Measured at baseline, 12 week and 12 month follow-up.
measure: Change in the HOOS activities of daily living (ADL) function subscale
timeFrame: Measured at baseline, 12 week and 12 month follow-up.
measure: Change in the HOOS quality-of-life subscale
timeFrame: Measured at baseline, 12 week and 12 month follow-up.
measure: Change in the HOOS sports and recreation subscale
timeFrame: Measured at baseline, 12 week and 12 month follow-up.
measure: Global Perceived Effect (GPE)
timeFrame: Measured at 12 week and 12 month follow-up.
measure: Change in muscle strength
timeFrame: Measured at baseline, 12 week and 12 month follow-up.
measure: Change in the HOOS symptoms subscale
timeFrame: Measured at baseline, 12 week and 12 month follow-up.
measure: Adherence to the 12 week initial intervention
timeFrame: Registered throughout the 12 week initial intervention.
measure: Adherence to the 9 months of self-administered training
timeFrame: Registered throughout the 9 months follow-up period.
measure: AE (Adverse Events) & Serious Adverse Events (SAE)
timeFrame: Registered throughout the 12 month study period.
measure: Drop-outs
timeFrame: Registered throughout the 12 month study period.
Other outcomes:
measure: Number of joint replacements
timeFrame: Measured at baseline and 12 month follow-up.
measure: Productivity Costs Questionnaire (IPCQ)
timeFrame: Measured at 12 week and 6, 9, 12 month follow-up.
measure: Physical activity level
timeFrame: Measured at baseline, 12 week and 12 month follow-up.
measure: Change in pain measured on a Numerical Rating Scale (NRS)
timeFrame: Measured at baseline, 12 week and 12 month follow-up.
measure: Healthcare Utilization Questionnaire (HUQ)
timeFrame: Measured at baseline, 12 week and 6, 9, 12 month follow-up.
measure: Change in EuroQol Group 5-dimension 5-level (EQ-5D-5L)
timeFrame: Measured at baseline, 12 week and 6, 9, 12 month follow-up.
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University
city: Slagelse
country: Denmark
facility: Næstved-Slagelse-Ringsted Hospitals
Study officials:
affiliation: Aarhus University Hospital and Aarhus University
name: Troels Kjeldsen, MSd
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital and Aarhus University
name: Inger Mechlenburg, Prof.
role: STUDY_DIRECTOR
affiliation: Slagelse Hospital and University of Southern Denmark
name: Søren T Skou, Prof.
role: STUDY_DIRECTOR
affiliation: University of Aarhus
name: Ulrik Dalgas, Prof.
role: STUDY_DIRECTOR
References:
citation: Kjeldsen T, Dalgas U, Skou ST, van Tulder M, Bibby BM, Mechlenburg I. Progressive resistance training compared to neuromuscular exercise in patients with hip osteoarthritis and the additive effect of exercise booster sessions: protocol for a multicentre cluster randomised controlled trial (The Hip Booster Trial). BMJ Open. 2022 Sep 15;12(9):e061053. doi: 10.1136/bmjopen-2022-061053.