An interventional study of Progressive Resistance Training and no booster sessions and Progressive Resistance Training and booster sessions in Hip Osteoarthritis, sponsored by University of Aarhus. Completed at 3 sites in Denmark. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-05-24.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
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.
642 studies on the registry are indexed under Osteoarthritis, Hip; 122 are open to participants now.
This study's enrollment of 160 is above the median of 90 across 458 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →University of Aarhus is the lead sponsor of 1,299 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
PRT
Other: Progressive Resistance Training and no booster sessions
PRT + Booster sessions
Other: Progressive Resistance Training and booster sessions
NEMEX
Other: Neuromuscular exercise and no booster sessions
NEMEX + Booster sessions
Other: Neuromuscular exercise and booster sessions
An initial 12-week exercise intervention, consisting of 1-hour group sessions of progressive resistance training supervised by a physiotherapist 2 times per week. 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. The progression will be in line with guidelines provided by the American College of Sports Medicine. The intensity will follow repetition maximum (RM) targets, from 12 RM for the first week towards 8 RM for the last weeks. After the 12 weeks, this group consists of patients who are randomized to receive no further treatment. For the following 9 months, these patients are given a membership to a fitness center where they are encouraged to continue the same exercise regime.
An initial 12-week exercise intervention, consisting of 1-hour group sessions of progressive resistance training supervised by a physiotherapist 2 times per week. 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. The progression will be in line with guidelines provided by the American College of Sports Medicine. The intensity will follow repetition maximum (RM) targets, from 12 RM for the first week towards 8 RM for the last weeks. After the 12 weeks, this group consists of patients who are randomized to receive 4 booster sessions (at 1, 3, 5 and 7 months after termination of the initial 12 week intervention). Additionally, for the following 9 months, these patients are given a membership to a fitness center where they are encouraged to continue the same exercise regime without supervision.
An initial 12-week exercise intervention, consisting of 1-hour group sessions of progressive resistance training supervised by a physiotherapist 2 times per week. 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. Progression is made when an exercise is performed with good sensorimotor control and good quality of the performance and with minimal exertion and adequate control of the movement. After the 12 weeks, this group consists of patients who are randomized to receive no further treatment. For the following 9 months, these patients are given equipment and encouraged to continue the same exercise regime at home without supervision.
An initial 12-week exercise intervention, consisting of 1-hour group sessions of progressive resistance training supervised by a physiotherapist 2 times per week. 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. Progression is made when an exercise is performed with good sensorimotor control and good quality of the performance and with minimal exertion and adequate control of the movement. After the 12 weeks, this group consists of patients who are randomized to receive 4 booster sessions (at 1, 3, 5 and 7 months after termination of the initial 12 week intervention). Additionally, for the following 9 months, these patients are given equipment and encouraged to continue the same exercise regime at home.
Change in functional performance measured by the 30-seconds chair stand test
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.
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Change in 40m fast-paced walk test
Time (in seconds) taken to complete a 40 m course at fast walking pace.
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Change in 9 step stair climb test
Time (in seconds) taken to negotiate 9 steps on a standard step-height stair-way (up and down).
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Change in leg extension muscle power (watt/kg bodyweight)
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.
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Change in the HOOS pain subscale
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.
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Change in the HOOS activities of daily living (ADL) function subscale
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.
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Change in the HOOS quality-of-life subscale
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.
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Change in the HOOS sports and recreation subscale
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.
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Global Perceived Effect (GPE)
The GPE of the interventions will be assessed for three domains on a 7-point Likert scale
Time frame: Measured at 12 week and 12 month follow-up.
Change in muscle strength
Muscle strength is measured in a standardized one-repetition maximum test for the leg press exercise.
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Change in the HOOS symptoms subscale
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.
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Adherence to the 12 week initial intervention
High adherence is defined as ≥ 80% attendance to the supervised interventions.
Time frame: Registered throughout the 12 week initial intervention.
Adherence to the 9 months of self-administered training
High adherence is defined by ≥ 80% of the assigned exercise programs performed at home or at the fitness center.
Time frame: Registered throughout the 9 months follow-up period.
AE (Adverse Events) & Serious Adverse Events (SAE)
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.
Time frame: Registered throughout the 12 month study period.
Drop-outs
Number og drop-out from the training interventions.
Time frame: Registered throughout the 12 month study period.
Number of joint replacements
Patient-reported joint replacements
Time frame: Measured at baseline and 12 month follow-up.
Productivity Costs Questionnaire (IPCQ)
The IPCQ questionnaire includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work
Time frame: Measured at 12 week and 6, 9, 12 month follow-up.
Physical activity level
Patient reported physical activity levels is assessed with a three domain questionnaire.
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Change in pain measured on a Numerical Rating Scale (NRS)
NRS pain score will be measured before and after each exercise session and at each follow-up evaluation before and after completing the functional performance tests.
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Healthcare Utilization Questionnaire (HUQ)
The HUQ is a nine-item patient-reported outcome measure designed to assess healthcare and medicine usage.
Time frame: Measured at baseline, 12 week and 6, 9, 12 month follow-up.
Change in EuroQol Group 5-dimension 5-level (EQ-5D-5L)
The EQ-5D-5L is a five-item patient-reported outcome measure designed to assess generic health-related quality-of-life. The total score of the descriptive index and EQ-VAS ranges from -0.624 (worst) to 1.000 (best) and 0 (worst imaginable health) to 100 (best imaginable health), respectively.
Time frame: Measured at baseline, 12 week and 6, 9, 12 month follow-up.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Anonymised patient-level data for the primary and all secondary outcome measures will be made available if required by the scientific journal, in which the results of the trial are published.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will be available after publication of the trial.
Access criteria: Data access will be reviewed by the author group. Requesters will be required to sign a Data Access Agreement.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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