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

NCT04714047 | Completed DMC

• 1 other identifier: HipBooster
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

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.

Conditions

Hip Osteoarthritis

Keywords

Progressive Resistance Training; Neuromuscular Exercise; Physical Therapy; Physical Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Change in 40m fast-paced walk test

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

• Change in 9 step stair climb test

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

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

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

• Change in the HOOS pain subscale

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

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

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

Other Outcomes (6)

• Number of joint replacements

  Measured at baseline and 12 month follow-up.

• Productivity Costs Questionnaire (IPCQ)

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

• Physical activity level

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

Study Arms (4)

Group 1:

EXPERIMENTAL

PRT

Other: Progressive Resistance Training and no booster sessions

Group 2:

EXPERIMENTAL

PRT + Booster sessions

Other: Progressive Resistance Training and booster sessions

Group 3:

ACTIVE COMPARATOR

NEMEX

Other: Neuromuscular exercise and no booster sessions

Group 4:

EXPERIMENTAL

NEMEX + Booster sessions

Other: Neuromuscular exercise and booster sessions

Interventions

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.

Group 1:

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.

Group 2:

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.

Group 3:

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.

Group 4:

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 comorbidity that prevents exercising
• Adequacy in written and spoken Danish
• Not being a candidate for total hip arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

Aarhus University

Aarhus, Denmark

Location

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Næstved-Slagelse-Ringsted Hospitals

Slagelse, Denmark

Location

Related Publications (3)

• 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.

  PMID: 40712915 DERIVED

• Kjeldsen 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.

  PMID: 38588540 DERIVED

• 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.

  PMID: 36109033 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Troels Kjeldsen, MSd

  Aarhus University Hospital and Aarhus University

  PRINCIPAL INVESTIGATOR

• Inger Mechlenburg, Prof.

  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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 19, 2021
• Study Start: January 18, 2021
• Primary Completion: May 3, 2024
• Study Completion: May 3, 2024
• Last Updated: May 24, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

DK (3)