Hip OsteoarthritisHipBoosterNCT04714047
Progressive Resistance Training Compared to Neuromuscular Exercise in Patients With Hip Osteoarthritis
A study testing Progressive Resistance Training and no booster sessions, Progressive Resistance Training and booster sessions and Neuromuscular exercise and no booster sessions in people with Hip Osteoarthritis, run by University of Aarhus at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Progressive Resistance Training and no booster sessions, Progressive Resistance Training and booster sessions and Neuromuscular exercise and no booster sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesDenmark
- Study dates
- 18 Jan 2021to 3 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aarhus University
Aarhus
Aarhus University Hospital
Aarhus N, 8200
Næstved-Slagelse-Ringsted Hospitals
Slagelse
About this study
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
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.
Read the 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.
- Conditions
- Hip Osteoarthritis
- Being tested
- Progressive Resistance Training and no booster sessions, Progressive Resistance Training and booster sessions, Neuromuscular exercise and no booster sessions, Neuromuscular exercise and booster sessions
- Keywords
- Progressive Resistance Training, Neuromuscular Exercise, Physical Therapy, Physical Rehabilitation
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Resistance Training and no booster sessionsOther
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 sessionsOther
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 sessionsOther
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 sessionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: | Experimental | PRT Receives: Other: Progressive Resistance Training and no booster sessions |
| Group 2: | Experimental | PRT + Booster sessions Receives: Other: Progressive Resistance Training and booster sessions |
| Group 3: | Active comparator | NEMEX Receives: Other: Neuromuscular exercise and no booster sessions |
| Group 4: | Experimental | NEMEX + Booster sessions Receives: Other: Neuromuscular exercise and booster sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline, 12 week and 12 month follow-up.
Secondary outcomes (14)
Change in 40m fast-paced walk test
Time (in seconds) taken to complete a 40 m course at fast walking pace.
Measured: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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.
Measured: 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.
Measured: 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.
Measured: Registered throughout the 12 month study period.
Drop-outs
Number og drop-out from the training interventions.
Measured: Registered throughout the 12 month study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start18 Jan 2021
- Primary completion3 May 2024
- Study completion3 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Vejle Hospital, Naestved Hospital, Regional Hospital Holstebro, Aarhus University Hospital, Physiotherapy Associates, Slagelse Hospital, University of Southern Denmark, Regionshospitalet Silkeborg
- Responsible party
- Sponsor
- Investigators
- Troels Kjeldsen, MSd, Principal investigator, Aarhus University Hospital and Aarhus UniversityInger Mechlenburg, Prof., Study director, Aarhus University Hospital and Aarhus UniversitySøren T Skou, Prof., Study director, Slagelse Hospital and University of Southern DenmarkUlrik Dalgas, Prof., Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714047
- Sponsor's protocol ID
- HipBooster
- Acronym
- HipBooster
- Status last verified
- May 2023
- First submitted
- 15 Jan 2021
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Kjeldsen T, Dalgas U, Skou ST, Tonning LU, Ingwersen KG, Birch S, Holm PM, Garval M, Varnum C, Callesen J, Foldager F, Bibby BM, Mechlenburg I. Booster sessions for maintaining the effect of neuromuscular exercise and progressive resistance training in hip osteoarthritis: 12-month follow-up from a multicenter cluster-randomized controlled trial. Osteoarthritis Cartilage. 2025 Nov;33(11):1393-1403. doi: 10.1016/j.joca.2025.07.012. Epub 2025 Jul 23.
PubMed 40712915Kjeldsen T, Skou ST, Dalgas U, Tonning LU, Ingwersen KG, Birch S, Holm PM, Frydendal T, Garval M, Varnum C, Bibby BM, Mechlenburg I. Progressive Resistance Training or Neuromuscular Exercise for Hip Osteoarthritis : A Multicenter Cluster Randomized Controlled Trial. Ann Intern Med. 2024 May;177(5):573-582. doi: 10.7326/M23-3225. Epub 2024 Apr 9.
PubMed 38588540Kjeldsen 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.
PubMed 36109033
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04714047
- Acronym / sponsor ID
- HipBooster / HipBooster
- Conditions
- Hip Osteoarthritis
- Keywords
- Progressive Resistance Training, Neuromuscular Exercise, Physical Therapy, Physical Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Vejle Hospital, Naestved Hospital, Regional Hospital Holstebro, Aarhus University Hospital, Physiotherapy Associates, Slagelse Hospital, University of Southern Denmark, Regionshospitalet Silkeborg
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: | Experimental | Other: Progressive Resistance Training and no booster sessionsPRT |
| Group 2: | Experimental | Other: Progressive Resistance Training and booster sessionsPRT + Booster sessions |
| Group 3: | Active comparator | Other: Neuromuscular exercise and no booster sessionsNEMEX |
| Group 4: | Experimental | Other: Neuromuscular exercise and booster sessionsNEMEX + Booster sessions |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Resistance Training and no booster sessionsAn 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. | Other | Group 1: |
| Progressive Resistance Training and booster sessionsAn 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. | Other | Group 2: |
| Neuromuscular exercise and no booster sessionsAn 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. | Other | Group 3: |
| Neuromuscular exercise and booster sessionsAn 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. | Other | Group 4: |
Primary outcome
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.
14 secondary outcomes
Change in 40m fast-paced walk test
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Change in 9 step stair climb test
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Change in leg extension muscle power (watt/kg bodyweight)
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Change in the HOOS pain subscale
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Change in the HOOS activities of daily living (ADL) function subscale
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Change in the HOOS quality-of-life subscale
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Change in the HOOS sports and recreation subscale
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Global Perceived Effect (GPE)
Time frame: Measured at 12 week and 12 month follow-up.
Change in muscle strength
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Change in the HOOS symptoms subscale
Time frame: Measured at baseline, 12 week and 12 month follow-up.
Adherence to the 12 week initial intervention
Time frame: Registered throughout the 12 week initial intervention.
Adherence to the 9 months of self-administered training
Time frame: Registered throughout the 9 months follow-up period.
AE (Adverse Events) & Serious Adverse Events (SAE)
Time frame: Registered throughout the 12 month study period.
Drop-outs
Time frame: Registered throughout the 12 month study period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Derived from this study: PubMed 40712915Kjeldsen T, Dalgas U, Skou ST, Tonning LU, Ingwersen KG, Birch S, Holm PM, Garval M, Varnum C, Callesen J, Foldager F, Bibby BM, Mechlenburg I. Booster sessions for maintaining the effect of neuromuscular exercise and progressive resistance training in hip osteoarthritis: 12-month follow-up from a multicenter cluster-randomized controlled trial. Osteoarthritis Cartilage. 2025 Nov;33(11):1393-1403. doi: 10.1016/j.joca.2025.07.012. Epub 2025 Jul 23.
- Derived from this study: PubMed 38588540Kjeldsen T, Skou ST, Dalgas U, Tonning LU, Ingwersen KG, Birch S, Holm PM, Frydendal T, Garval M, Varnum C, Bibby BM, Mechlenburg I. Progressive Resistance Training or Neuromuscular Exercise for Hip Osteoarthritis : A Multicenter Cluster Randomized Controlled Trial. Ann Intern Med. 2024 May;177(5):573-582. doi: 10.7326/M23-3225. Epub 2024 Apr 9.
- Derived from this study: PubMed 36109033Kjeldsen 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Troels Kjeldsen, MSd principal investigator
Aarhus University Hospital and Aarhus University
Inger Mechlenburg, Prof. study director
Aarhus University Hospital and Aarhus University
Søren T Skou, Prof. study director
Slagelse Hospital and University of Southern Denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Resistance Training and no booster sessions, Progressive Resistance Training and booster sessions and Neuromuscular exercise and no booster sessions in people with Hip Osteoarthritis, run by University of Aarhus at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional performance measured by the 30-seconds chair stand test (time frame: Measured at baseline, 12 week and 12 month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04714047, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.