NCT05031390

Brief Summary

The aim of the study is to investigate the feasibility of a training intervention in patients with femoroacetabular impingement syndrome (FAIS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

August 12, 2021

Last Update Submit

July 30, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of completed exercise sessions

    Number of completed exercise sessions. A high adherence is defined as attendance of \> 75% of planned sessions

    0-12 weeks

  • Completion of training program

    The training program is considered completed if patients are not dropping out of the study before the end of the 12 weeks. Completion rate will be calculated as % patients who completed the study

    0-12 weeks

Secondary Outcomes (7)

  • The Copenhagen Hip and Groin Outcome Score (HAGOS)

    Change from 0-12 weeks

  • The International Hip Outcome Tool (iHOT-33)

    Change from 0-12 weeks

  • The Hip Sports Activity Scale (HSAS)

    Change from 0-12 weeks

  • Maximal hip muscle strength

    Change from 0-12 weeks

  • One-legged hop for distance

    0-12 weeks

  • +2 more secondary outcomes

Study Arms (1)

Physiotherapist-led training

EXPERIMENTAL

Physiotherapy-led training of patients with FAIS

Procedure: Physiotherapist-led training

Interventions

Patients will undergo a 12-week physiotherapist-led training program consisting of 8 supervised sessions and home-based training in between

Physiotherapist-led training

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18-50 years old
  • Diagnosed with FAIS according to the Warwick agreement
  • Patients having cam morphology should have an alpha angle of \> 55 degrees on an anterior-posterior radiograph.
  • Patients having pincer should have a lateral centre edge angle of \>39 degrees on an anterior-posterior radiograph.
  • Lateral joint space width should be \>3 mm.
  • Body mass index is below 30.
  • Motivated for participation in a 12 week training program with 8 physical attendances.

You may not qualify if:

  • Received physiotherapist-led treatment in the past 3 months,
  • Previous hip surgery in included hip or other major hip injury,
  • Systemic conditions e.g. rheumatoid arthritis, cancer,
  • Chronical pain syndromes,
  • Unable to perform testing procedures,
  • Unable to attend a 12-week treatment program or baseline and follow-up assessments
  • Contraindications to radiographs (e.g. pregnancy)
  • Unable to read or understand questionnaires and/or instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Signe Kierkegaard

Horsens, Danmark, DK-8700, Denmark

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Signe Kierkegaard, PhD

    Regionshospitalet Horsens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research

Study Record Dates

First Submitted

August 12, 2021

First Posted

September 1, 2021

Study Start

September 1, 2021

Primary Completion

August 1, 2022

Study Completion

December 1, 2022

Last Updated

August 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Pilot study with few participants.

Locations