Progressive Resistance Training Compared to Neuromuscular Exercise in Patients With Hip Osteoarthritis (HipBooster)

Progressive Resistance Training Compared to Neuromuscular Exercise in Patients With Hip Osteoarthritis, and the Additive Effect of Booster Sessions: A Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Other: Progressive Resistance Training and no booster sessions; Other: Progressive Resistance Training and booster sessions; Other: Neuromuscular exercise and no booster sessions; Other: Neuromuscular exercise and booster sessions

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Aarhus University
  • Aarhus N, Denmark, 8200
    • Aarhus University Hospital
  • Slagelse, Denmark
    • Næstved-Slagelse-Ringsted Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: PRT	Other: Progressive Resistance Training and no 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.
Experimental: Group 2: PRT + Booster sessions	Other: Progressive Resistance Training 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 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.
Active Comparator: Group 3: NEMEX	Other: Neuromuscular exercise and no 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 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.
Experimental: Group 4: 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measured at baseline, 12 week and 12 month follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 40m fast-paced walk test	Time (in seconds) taken to complete a 40 m course at fast walking pace.	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).	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.	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.	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.	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.	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.	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	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.	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.	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.	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.	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.	Registered throughout the 12 month study period.
Drop-outs	Number og drop-out from the training interventions.	Registered throughout the 12 month study period.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of joint replacements	Patient-reported joint replacements	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	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.	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.	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.	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.	Measured at baseline, 12 week and 6, 9, 12 month follow-up.

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; University of Southern Denmark; Vejle Hospital; Naestved Hospital; Slagelse Hospital; Regional Hospital Holstebro; Regionshospitalet Silkeborg; Physiotherapy Associates
• Investigators: Principal Investigator: Troels Kjeldsen, MSd, Aarhus University Hospital and Aarhus University; Study Director: Søren T Skou, Prof., Slagelse Hospital and University of Southern Denmark; Study Director: Ulrik Dalgas, Prof., University of Aarhus; Study Director: Inger Mechlenburg, Prof., Aarhus University Hospital and Aarhus University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Actual): May 3, 2024
• Study Completion (Actual): May 3, 2024

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Physical Therapy; Progressive Resistance Training; Physical Rehabilitation; Neuromuscular Exercise
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: HipBooster

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available after publication of the trial.
• IPD Sharing Access Criteria: Data access will be reviewed by the author group. Requesters will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No