3 Months Semi-supervised Exercise Intervention for Patients With Hip Abductor Tendon Pathology (HATP): A Prospective Clinical Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes in patient-reported pain measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
Study Overview
Brief Summary
This prospective cohort trial will investigate a progressive exercise protocol and patient education for patients with hip abductor tendon pathology. The primary outcome is patient reported pain measured by the revised Copenhagen Hip And Groin Outcome Score (HAGOS), that will be conducted at baseline and at a 12 week follow-up.
Detailed Description
This study protocol describes an interventional pragmatic prospective single-group cohort study, where the primary endpoint is change in hip pain measured with the revised HAGOS pain subscale following a 12 week intervention. Throughout the 12 weeks, eight physiotherapist-led exercise sessions will take place at Horsens Regional Hospital (HRH). Further, at the sessions at HRH patient education will be performed by the supervising physiotherapist. The first supervised sessions will be performed in continuation of the baseline assessment. The patients will be instructed to do the exercises daily at home in the time period between the physiotherapist-led sessions.
The primary aim is to investigate changes in patient-reported hip pain based on the subscale "pain" from the revised Copenhagen Hip And Groin Outcome Score (HAGOS) from baseline to 12 week follow-up.
It is hypothesized that the revised HAGOS pain score will improve from baseline to 12 week follow-up.
Secondarily explorative subgroup analyses regarding whether patients with different MRI findings, pain profiles, age, sex and body mass index (BMI) respond differently to the intervention, will be performed.
All outcomes conducted will be published. That is, patient-reported outcomes, muscle strength, functional capacity and adherence to the exercise protocol.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-75 years
- •MRI verified HATP
- •Lateral hip pain duration > 6 months
- •Ability to read and understand Danish.
Exclusion Criteria
- •Corticosteroid injection in the affected hip joint within the last six weeks prior to the intervention
- •Previous bone-related surgery to the affected hip,
- •Signs of bilateral HATP
- •X-ray verified hip osteoarthritis
- •Pregnancy
Arms & Interventions
Physiotherapist-led exercise
Physiotherapy-led exercise of patients with lateral hip pain
Intervention: Exercise and Patient Education (Procedure)
Outcomes
Primary Outcomes
Changes in patient-reported pain measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
Time Frame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
The subscale "pain" on HAGOS measures the patients perception of hip and/or groin pain. It consist of ten items. A score from 0 to 100 is calculated, where a higher score is indicating lower pain.
Secondary Outcomes
- Changes in patient-reported symptoms measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)(From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.)
- Changes in patient-reported physical function in sport and recreational activities (sport/recreation) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)(From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.)
- Changes in patient-reported participation in physical activities (PA) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)(From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.)
- Changes in the patient-reported outcome measure Oxford Hip Score (continuous data)(From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.)
- Changes of maximal isometric hip extension muscle strength (continuous data)(From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.)
- Changes of the number of repetitions of a 30 second sit to stand test (continuous data)(From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.)
- Global Rating of Change (GRoC)(The outcome is conducted at 6-week and 3-months follow-up.)
- Changes in the patient-reported outcome measure The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) (continuous data)(From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.)
- Changes of maximal isometric hip abduction muscle strength (continuous data)(From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.)
- Changes of maximal isometric hip adduction muscle strength (continuous data)(From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.)
- Changes of maximal isometric hip flexion muscle strength (continuous data)(From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.)
- Changes in patient-reported physical function in daily living (ADL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)(From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.)
- Changes in the patient-reported outcome measure EQ-5D-5L (continuous data)(From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.)
- Lateral hip pain on a numerical pain rating scale (NRS)(From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.)
- Changes in patient-reported quality of life (QOL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)(From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.)
Investigators
Jeppe Lange
MD, PhD
Horsens Hospital