Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Hip Osteoarthritis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 45 years and 125 years
Gender
Both males and females

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 eac...

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- 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.

Tracking Information

NCT #
NCT04714047
Collaborators
  • Vejle Hospital
  • Naestved Hospital
  • Regional Hospital Holstebro
  • Aarhus University Hospital
  • Physiotherapy Associates
  • Slagelse Hospital
  • University of Southern Denmark
Investigators
Principal Investigator: Troels Kjeldsen, MSd Aarhus University Hospital and Aarhus University Study Director: 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