Progressive Exercise Therapy and Patient Education Compared With Usual Care in Patients With Hip Dysplasia

Overview

This trial will investigate the effectiveness of randomisation to progressive exercise therapy and patient education compared with randomisation to usual care on self-reported pain in patients with hip dysplasia, who are not candidates for periacetabular osteotomy. Participating patients will be allocated to either progressive exercise therapy and patient education or usual care. Alongside, a health economic study and a process evaluation study will be conducted.

Full Title of Study: “MovetheHip-trial: The Effectiveness of Exercise Therapy and Patient Education Compared With Usual Care on Self-reported Pain in Patients With Hip Dysplasia Who Are Not Candidates for Periacetabular Osteotomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 2024

Detailed Description

This study is an assessor-blinded randomised controlled trial. Alongside, a health economic study and a process evaluation study will be conducted. Participating patients will be allocated to either progressive exercise therapy and patient education or usual care at a 1:1 ratio. The primary outcome is change in self-reported pain measured with Copenhagen Hip and Groin Outcome Score (HAGOS) from baseline to 6-month follow-up. The effectiveness of progressive exercise therapy and patient education compared with usual care will be reported in the primary trial paper, including the primary outcome and the following secondary outcomes: HAGOS symptoms, HAGOS function in daily living (ADL), HAGOS function in sport and recreation (sport/recreation), participation in physical activity (participation), quality of life (QOL), impact of hip disease with the Short Version of the international Hip Outcome Tool (iHOT-12), lower limb reach length (anterior, posteromedial, posterolateral), single-leg hip for distance (SLHD) test and hip muscle strength (flexion, extension and abduction). The primary aim of this trial is to investigate the effectiveness of randomisation to progressive exercise therapy and patient education compared with randomisation to usual care on changes in self-reported pain measured with HAGOS over a 6-month follow-up in patients with hip dysplasia, who are not candidates for PAO. The primary hypothesis: Patients randomised to progressive exercise therapy and patient education will improve at least 10 points more in HAGOS pain compared with those randomised to usual care over a 6-month follow-up. The secondary aims: – To investigate the effectiveness of randomisation to progressive exercise therapy and patient education compared with randomisation to usual care on changes in HAGOS symptoms, HAGOS ADL, HAGOS sport/recreation, HAGOS participation, HAGOS QOL and iHOT-12 over a 6-month follow-up in patients with hip dysplasia, who are not candidates for PAO. – To investigate the effectiveness of randomisation to progressive exercise therapy and patient education compared with randomisation to usual care on changes in functional performance over a 6-month follow-up in patients with hip dysplasia, who are not candidates for PAO. – To investigate the effectiveness of randomisation to progressive exercise therapy and patient education compared with randomisation to usual care on changes in hip flexion, extension and abduction strength over a 6-month follow-up in patients with hip dysplasia, who are not candidates for PAO. A full trial protocol will be published and made publicly available. In continuous outcomes, between-group comparison from baseline to 6-month follow-up will be analysed with either an unpaired t-test or a mixed effect model with patient as a random factor and time and allocation group as fixed factors. In dichotomous outcomes, between-group comparison from baseline to 6-month follow-up will be analysed with the pseudo-observation method using cumulative risk difference as measure of association. Outcomes for the primary trial paper will be measured at baseline, 3- and 6-month follow-up and analysed using intention-to-treat analyses. In this paper, all collected outcomes will be listed, and it will be described that the below listed will be reported in other papers (i.e. health economic study and process evaluation study) and secondary papers. In the health economic study, the investigators aimed to evaluate the cost-utility and cost-effectiveness of randomisation to progressive exercise therapy and patient education compared with randomisation to usual care over a 12-month follow-up in patients with hip dysplasia, who are not candidates for PAO. Outcomes for this paper wil be measured at baseline, 3-, 6-, 9- and 12-month follow-up. The Incremental Cost-effectiveness Ratio (ICER) will be calculated by dividing the difference in costs by the difference in effects (quality-adjusted life years and HAGOS pain). The investigators will use the method of bootstrapping to estimate the 95% confidence intervals around cost differences and the uncertainty surrounding the ICERs. Uncertainty will be shown in cost-effectiveness planes and cost-effectiveness acceptability curves. Sensitivity analyses will be performed to test the robustness of the study results. In the process evaluation study, the investigators aimed to evaluate progressive exercise therapy and patient education in a process evaluation in terms of implementation, mechanics of impact and contextual factors. Delivery of the exercise therapy intervention and patient education will be evaluated in terms of implementation covering fidelity (i.e. quantify if intervention is delivered as intended), dose (quantify numbers of and time in supervised sessions and numbers of home-bases sessions), and reach (quantify pattern in uptake and adherence by baseline patient characteristics). Mechanics of impact will be evaluated in terms of experiences of interactions between the intervention providers, patients in the intervention group and the intervention, evaluated by interviewing 15-20 patients at baseline and at 6-month follow-up. Context will be evaluated in terms of any external influences. The below listed will be reported in secondary papers with a clear reference to the primary trial paper and trial registration, and it will hold "secondary analyses from a randomised controlled trial" in the title. 1: By using instrumental-variable analysis with adherence as exposure and randomisation as an instrument, the investigators aimed to investigate the efficacy of progressive exercise therapy and patient education compared with usual care on changes in HAGOS subscales, changes in functional performance and changes in hip muscle strength over a 6-month follow-up in patients with hip dysplasia, who are not candidates for PAO. 2: The investigators aimed to investigate if muscle-tendon pain and pain sensitisation (temporal summation of pain and pressure pain threshold) modify the relationship between randomisation to exercise therapy and patient education compared with randomisation to usual care on changes in HAGOS subscales, functional performance and hip muscle strength over a 6-month follow-up in patients with hip dysplasia, who are not candidates for PAO. In addition, the investigators plan to evaluate the psychometric properties of HAGOS and iHOT-12 in patients with hip dysplasia, who are not candidates for PAO, and finally, the investigators plan to describe if hip osteoarthritis progresses over 5 and 10 years using the Tönnis osteoarthritis classification in patients with hip dysplasia, who are not candidates for PAO.

Interventions

  • Other: Progressive exercise therapy and patient education
    • Over a period of 6-month, patients will be offered eight individual physiotherapist-supervised training sessions. In these sessions, patients will be instructed in a home-based progressive exercise therapy programme and given patient education. The programme includes four exercises covering strength and stability training. The exercises will be performed in sets of three with a minimum of 5 repetitions, and patients will be instructed to perform a minimum of three training sessions each week. Each of the exercises can be progressed through three levels of difficulty levels, allowing for individualised treatment with regard to exercise quality and perceived exertion according to Borg CR10 scale. Exercises will be performed on a perceived exertion level from somewhat hard (level 5) to very hard (level 7). Patient education includes pain management, focus on exercise adherence and progression, and advice on physical activity.
  • Other: Usual Care
    • Patients will follow usual care, including an individual consultation on self-management of hip symptoms and general advice on exercise and physical activity.

Arms, Groups and Cohorts

  • Experimental: Progressive exercise therapy and patient education
    • 6-months
  • Active Comparator: Usual Care
    • 6-months

Clinical Trial Outcome Measures

Primary Measures

  • Change in self-reported pain measured with The Copenhagen Hip and Groin Outcome Score (HAGOS) (continuous data)
    • Time Frame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up (health economic study) and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
    • HAGOS pain sub-item measures degree of hip and/or groin pain through ten individual questions on a score from 0 to 100, higher score indicates lower pain.

Secondary Measures

  • Change in self-reported symptoms measured with HAGOS (continuous data)
    • Time Frame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up (health economic study) and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
    • HAGOS symptoms sub-item measures hip and/or groin symptoms and difficulties through seven individual questions on a score from 0 to 100, higher score indicates lower symptoms.
  • Change in self-reported physical function, daily living (ADL) measured with HAGOS (continuous data)
    • Time Frame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up (health economic study) and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
    • HAGOS ADL sub-item measures degree of difficulty due to hip and/or groin problems through five individual questions on a score from 0 to 100, higher score indicates higher function.
  • Change in self-reported physical function in sports and recreational activities (sport/recreation) measured with HAGOS (continuous data)
    • Time Frame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up (health economic study) and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
    • HAGOS sport/recreation sub-item measures degree of difficulty due to hip and/or groin problems through eight individual questions on a score from 0 to 100, higher score indicates higher function.
  • Change in self-reported participation in physical activities (participation) measured with HAGOS (continuous data)
    • Time Frame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up (health economic study) and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
    • HAGOS participation sub-item measures how degree of ability to participate in physical activities is affected by hip and/or groin problems through two individual questions on a score from 0 to 100, higher score indicates higher ability to participate in physical activities.
  • Change in self-reported quality of life (QOL) measured with HAGOS (continuous data)
    • Time Frame: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up (health economic study) and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
    • HAGOS QOL sub-item measures hip-related quality of life through five individual questions on a score from 0 to 100, higher score indicates higher quality of life.
  • Change in impact of hip disease using the Short Version of the International Hip Outcome Tool (iHOT- 12) (continuous data)
    • Time Frame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up. In addition at 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)
    • iHOT-12 measures impact of hip disease in young, active patients through 12 questions on a score from 0-100.
  • Change in anterior lower limb reach distance measured with the Y-balance test (continuous data)
    • Time Frame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
    • Anterior lower limb reach distance measures functional performance when maintaining balance on one leg, reported in cm normalised to limb length.
  • Change in posteromedial lower limb reach distance measured with the Y-balance test (continuous data)
    • Time Frame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
    • Posteromedial lower limb reach distance measures functional performance when maintaining balance on one leg, reported in cm normalised to limb length.
  • Change in posterolateral lower limb reach distance measured with the Y-balance test (continuous data)
    • Time Frame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
    • Posterolateral lower limb reach distance measures functional performance when maintaining balance on one leg, reported in cm normalised to limb length.
  • Change in single-leg jump distance measured with single-leg hop for distance test (continuous data)
    • Time Frame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
    • Single-leg jump test measures functional performance when jumping on one leg, reported in cm normalised to height.
  • Change in isometric hip flexion strength using a dynamometer with external belt-fixation (continuous data)
    • Time Frame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
    • Isometric hip flexion test measures isometric maximum voluntary contraction (MVC) in sitting position. Strength values will be normalised to moment arms and weight and reported in Nm/kg bodyweight.
  • Change in isometric hip extension strength using a dynamometer with external belt-fixation (continuous data)
    • Time Frame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
    • Isometric hip extension test measures isometric maximum voluntary contraction (MVC) in prone position. Strength values will be normalised to moment arms and weight and reported in Nm/kg bodyweight.
  • Change in isometric hip abduction strength using a dynamometer with external belt-fixation (continuous data)
    • Time Frame: From baseline to 6-month follow-up. Outcome measured at baseline and 6-month follow-up
    • Isometric hip abduction test measures isometric maximum voluntary contraction (MVC) in supine position. Strength values will be normalised to moment arms and weight and reported in Nm/kg bodyweight.

Participating in This Clinical Trial

Inclusion Criteria

  • Radiographically verified hip dysplasia by a Wiberg's center edge (CE) angle 10-25 degrees and an acetabular Index (AI) angle >10 degrees – Hip and/or groin pain as primary pain for at least three months – Candidate for periacetabular osteotomy, but does not wish to undergo surgery or not candidate for PAO due to negative impingement test, BMI >25, hip osteoarthritis, age >45 years or reduced hip range of motion – Willing to commute to eight supervised training sessions Exclusion Criteria:

  • Self-reported pain score >80 points measured with Copenhagen Hip and Groin outcome score – Any major planned surgery (i.e. arthroplastic surgery or discectomy surgery) – BMI >35 – Acetabular retroversion defined by crossover sign and posterior wall sign – Calvé Legg Perthes or epiphysiolysis – Previous pelvic/hip surgery in index limb – Previous pelvic/hip surgery within the last 2 years in contralateral limb – Previous surgery due to herniated disc or spondylodesis – Previous arthroplastic surgery in the hip, knee or ankle – Physical (pregnancy/trauma), neurological, medical or rheumatic conditions severely affecting the hip function – Inadequacy in written and spoken Danish, mental illness or other conditions affecting the ability to follow mandatory procedures for participation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aarhus University Hospital
  • Collaborator
    • Research Unit for General Practice, Aarhus University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Julie S Jacobsen, PhD, Principal Investigator, VIA University College
    • Inger Mechlenburg, DMSc, Study Director, Aarhus University Hospital
    • Kristian Thorborg, PhD, Study Chair, Copenhagen University Hospital, Hvidovre
    • Rasmus Ø Nielsen, PhD, Study Chair, University of Aarhus
    • Stig S Jakobsen, PhD, Study Chair, Aarhus University Hospital
    • Lisa G Oestergaard, PhD, Study Chair, Defactum, Central Denmark Region
    • Kjeld Søballe, PhD, Study Chair, Aarhus University Hospital
  • Overall Contact(s)
    • Julie S Jacobsen, PhD, +4551866165, jsaj@via.dk

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