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Completed

NCT Number: NCT04714047

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

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.

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University, Aarhus, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progressive Resistance Training and no booster sessions

Other

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.

Progressive Resistance Training and booster sessions

Other

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.

Neuromuscular exercise and no booster sessions

Other

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.

Neuromuscular exercise and booster sessions

Other

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.

Primary outcomes

  1. Change in functional performance measured by the 30-seconds chair stand test

    Time frame: 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 outcomes

  1. Change in 40m fast-paced walk test

    Time frame: Measured at baseline, 12 week and 12 month follow-up.

    Time (in seconds) taken to complete a 40 m course at fast walking pace.

  2. Change in 9 step stair climb test

    Time frame: 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).

  3. Change in leg extension muscle power (watt/kg bodyweight)

    Time frame: 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.

  4. Change in the HOOS pain subscale

    Time frame: 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.

  5. Change in the HOOS activities of daily living (ADL) function subscale

    Time frame: 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.

  6. Change in the HOOS quality-of-life subscale

    Time frame: 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.

  7. Change in the HOOS sports and recreation subscale

    Time frame: 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.

  8. Global Perceived Effect (GPE)

    Time frame: 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

  9. Change in muscle strength

    Time frame: 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.

  10. Change in the HOOS symptoms subscale

    Time frame: 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.

  11. Adherence to the 12 week initial intervention

    Time frame: Registered throughout the 12 week initial intervention.

    High adherence is defined as ≥ 80% attendance to the supervised interventions.

  12. Adherence to the 9 months of self-administered training

    Time frame: 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.

  13. AE (Adverse Events) & Serious Adverse Events (SAE)

    Time frame: 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.

  14. Drop-outs

    Time frame: Registered throughout the 12 month study period.

    Number og drop-out from the training interventions.

Other outcomes

  1. Number of joint replacements

    Time frame: Measured at baseline and 12 month follow-up.

    Patient-reported joint replacements

  2. Productivity Costs Questionnaire (IPCQ)

    Time frame: Measured at 12 week and 6, 9, 12 month follow-up.

    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

  3. Physical activity level

    Time frame: Measured at baseline, 12 week and 12 month follow-up.

    Patient reported physical activity levels is assessed with a three domain questionnaire.

  4. Change in pain measured on a Numerical Rating Scale (NRS)

    Time frame: Measured at baseline, 12 week and 12 month follow-up.

    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.

  5. Healthcare Utilization Questionnaire (HUQ)

    Time frame: Measured at baseline, 12 week and 6, 9, 12 month follow-up.

    The HUQ is a nine-item patient-reported outcome measure designed to assess healthcare and medicine usage.

  6. Change in EuroQol Group 5-dimension 5-level (EQ-5D-5L)

    Time frame: Measured at baseline, 12 week and 6, 9, 12 month follow-up.

    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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Naestved Hospital
  • Physiotherapy Associates
  • Regional Hospital Holstebro
  • Regionshospitalet Silkeborg
  • Slagelse Hospital
  • University of Southern Denmark
  • Vejle Hospital

Registry information

Official study 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

Acronym: HipBooster

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2021
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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