NCT06418217

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
May 2024Feb 2027

First Submitted

Initial submission to the registry

May 13, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

May 17, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

2.5 years

First QC Date

May 13, 2024

Last Update Submit

June 23, 2025

Conditions

Keywords

ExercisePatient educationLateral Hip PainRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Changes in patient-reported pain measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)

    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.

    From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

Secondary Outcomes (15)

  • 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 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 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 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.

  • +10 more secondary outcomes

Other Outcomes (1)

  • Adherence to the exercise program.

    From baseline to 3 months follow-up.

Study Arms (1)

Physiotherapist-led exercise

EXPERIMENTAL

Physiotherapy-led exercise of patients with lateral hip pain

Procedure: Exercise and Patient Education

Interventions

Patients will undergo a 12-week physiotherapist-led exercise program consisting of 8 supervised sessions and home-based training in between. Patients will keep training diaries, where each session is tracked in regards of completed repetitions and pain before and after the sessions. Each session will consist of four exercises.

Physiotherapist-led exercise

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years
  • MRI verified HATP
  • Lateral hip pain duration \> 6 months
  • Ability to read and understand Danish.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Horsens Regional Hospital

Horsens, Horsens, 8700, Denmark

RECRUITING

Related Publications (1)

  • Hogsholt M, Kierkegaard-Brochner S, Lange J, Thorborg K, Bohn MB. Physiotherapist-led education and exercise for patients with MRI-verified hip abductor tendon pathology: a protocol for a prospective cohort study. BMJ Open. 2025 Sep 11;15(9):e106517. doi: 10.1136/bmjopen-2025-106517.

MeSH Terms

Conditions

Motor Activity

Interventions

ExercisePatient Education as Topic

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mathias Høgsholt, PT, PhD.st.

    Horsens Regional Hospital; Aarhus University

    PRINCIPAL INVESTIGATOR
  • Jeppe Lange, MD, PhD

    Horsens Regional Hospital; Aarhus University

    STUDY DIRECTOR
  • Signe Kierkegaard-Brøchner, PhD

    Regionshospitalet Horsens

    STUDY CHAIR
  • Kristian Thorborg, PhD

    Copenhagen University Hospital, Hvidovre

    STUDY CHAIR
  • Marie Bagger Bohn, MD, PhD

    Regionshospitalet Horsens

    STUDY CHAIR

Central Study Contacts

Mathias Høgsholt, PT,PhD.-st.

CONTACT

Jeppe Lange, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 13, 2024

First Posted

May 17, 2024

Study Start

May 17, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

What data will be shared: All quantitative individual participant data collected during the trial, after deidentification, and according to current Danish Data Protection Regulation and GDPR. With whom will data be shared: Researchers who provide a methodologically sound proposal. For what types of analyses: To achieve aims in the approved proposal. The abovementioned is based on Data Sharing Statements for Clinical Trial: A Requirement of the ICMJE located at: https://www.icmje.org/news-and-editorials/data\_sharing\_june\_2017.pdf

Shared Documents
STUDY PROTOCOL
Time Frame
Immediately following publication and ending 5 years following primary article publication.
Access Criteria
Proposals should be directed to mathhg@rm.dk. To gain access, data requestors will need to sign a data access agreement.

Locations