- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07105657
- Original Trial
The Outcome of Three Weeks Rehabilitation in Patients With a Total Hip or Knee Replacement Experiencing Persistent Physical Impairments (Rehab-hip-knee)
August 25, 2025 updated by: Jeppe Lange, Horsens Hospital
Patients with total hip or knee replacement experiencing persistant problems are offered 3 weeks of intensive rehabilitation.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Outcomes before, at the end of treatment and at 6 months follow up will be investigated.
Data will be handled separately for the two groups of patients: 42 with a total hip replacement and 42 with a total knee replacement.
Specific and generic outcomes will be collected.
Study Type
Observational
Enrollment (Estimated)
84
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Signe Kierkegaard-Brøchner, PhD
- Phone Number: 004578427882
- Email: signkier@rm.dk
Study Locations
-
-
-
Brædstrup, Denmark
- Recruiting
- Horsens Regional Hospital
-
Contact:
- Signe Kierkegaard-Brøchner, PhD
- Phone Number: 004578427882
- Email: signkier@rm.dk
-
Principal Investigator:
- Signe Kierkegaard-Brøchner, PhD
-
Sub-Investigator:
- Stian Langgård Jørgensen, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients who have a total hip or knee replacement experiencing persistant problems, hence are admitted to a 3 week intensive rehabilitation period.
Description
Inclusion Criteria:
- Patients with a total hip or knee replacement admitted for intensive rehabilitation
Exclusion Criteria:
- Patients unable to understand Danish
- Unable to participate in physical tests
- Unable to understand questionaires
- Unable to participate i 6 months follow up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Intervention group hip
Patients with a total hip replacement undergoing rehabilitation
|
Three weeks intensive rehabilitation where patients undergo group-based and individualised rehabilitation focusing at improving pain, function and quality of life for the patient
|
|
Intervention group knee
Patients with a total hip replacement undergoing rehabilitation
|
Three weeks intensive rehabilitation where patients undergo group-based and individualised rehabilitation focusing at improving pain, function and quality of life for the patient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HOOS/KOOS pain (0-100 score)
Time Frame: Change from baseline (0) to 3 weeks
|
Hip or knee related pain
|
Change from baseline (0) to 3 weeks
|
|
HOOS/KOOS ADL (0-100 score)
Time Frame: Change from baseline (0) to 3 weeks
|
Hip or knee related activities of daily living
|
Change from baseline (0) to 3 weeks
|
|
HOOS/KOOS quality of life (0-100 score)
Time Frame: Change from baseline (0) to 3 weeks
|
Hip or knee related quality of life
|
Change from baseline (0) to 3 weeks
|
|
HOOS/KOOS pain (0-100 score)
Time Frame: Change from 3 weeks to 7 months
|
Hip or knee related pain
|
Change from 3 weeks to 7 months
|
|
HOOS/KOOS ADL (0-100 score)
Time Frame: Change from 3 weeks to 7 months
|
Hip or knee related activities of daily living
|
Change from 3 weeks to 7 months
|
|
HOOS/KOOS quality of life (0-100 score)
Time Frame: Change from 3 weeks to 7 months
|
Hip or knee related quality of life
|
Change from 3 weeks to 7 months
|
|
Sit-to-stand test
Time Frame: Change from baseline (0) to 3 weeks
|
Number of completed sit to stands in 30 seconds
|
Change from baseline (0) to 3 weeks
|
|
Sit-to-stand test
Time Frame: Change from 3 weeks to 7 months
|
Number of completed sit to stands in 30 seconds
|
Change from 3 weeks to 7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient acceptable symptom state (yes/no)
Time Frame: 3 weeks follow up
|
Patients are asked with a single question if their current symptom state is acceptable
|
3 weeks follow up
|
|
Patient acceptable symptom state (yes/no)
Time Frame: 7 months follow up
|
Patients are asked with a single question if their current symptom state is acceptable
|
7 months follow up
|
|
HOOS/KOOS symptoms (0-100 score)
Time Frame: Change from baseline (0) to 3 weeks
|
Hip or knee related symptoms
|
Change from baseline (0) to 3 weeks
|
|
HOOS/KOOS symptoms (0-100 score)
Time Frame: Change from 3 weeks to 7 months
|
Hip or knee symptoms
|
Change from 3 weeks to 7 months
|
|
HOOS/KOOS sport/rec (0-100 score)
Time Frame: Change from baseline (0) to 3 weeks
|
Hip or knee related sport/rec
|
Change from baseline (0) to 3 weeks
|
|
HOOS/KOOS sport/rec (0-100 score)
Time Frame: Change from 3 weeks to 7 months
|
Hip or knee related sport/rec
|
Change from 3 weeks to 7 months
|
|
6 minute walk test
Time Frame: Change from baseline (0) to 3 weeks
|
The distance a patient can walk in 6 minutes
|
Change from baseline (0) to 3 weeks
|
|
6 minute walk test
Time Frame: Change from 3 weeks to 7 months
|
The distance a patient can walk in 6 minutes
|
Change from 3 weeks to 7 months
|
|
40 meter fast paced walk test
Time Frame: Change from baseline (0) to 3 weeks
|
The time a patient uses walking 40 meters fast
|
Change from baseline (0) to 3 weeks
|
|
40 meter fast paced walk test
Time Frame: Change from 3 weeks to 7 months
|
The time a patient uses walking 40 meters fast
|
Change from 3 weeks to 7 months
|
|
Stair test
Time Frame: Change from baseline (0) to 3 weeks
|
The time a patient uses to ascend and decend a staircase
|
Change from baseline (0) to 3 weeks
|
|
Stair test
Time Frame: Change from 3 weeks to 7 months
|
The time a patient uses to ascend and decend a staircase
|
Change from 3 weeks to 7 months
|
|
Pain catastrophising scale (0-52 score)
Time Frame: Baseline
|
Current level of pain catastrophising with 0 being the best
|
Baseline
|
|
Pain catastrophising scale (0-52 score)
Time Frame: 3 weeks
|
Current level of pain catastrophising with 0 being the best
|
3 weeks
|
|
Pain catastrophising scale (0-52 score)
Time Frame: 7 months
|
Current level of pain catastrophising with 0 being the best
|
7 months
|
|
Global rating of change (0-11 score)
Time Frame: Change from baseline to 3 weeks
|
Likert scale where patients indicate their overall rating of change since the beginning of the intervention
|
Change from baseline to 3 weeks
|
|
Global rating of change (0-11 score)
Time Frame: Change from baseline to 7 months
|
Likert scale where patients indicate their overall rating of change since the beginning of the intervention
|
Change from baseline to 7 months
|
|
The 5-level EQ-5D version (EQ-5D-5L) (0-5 scale)
Time Frame: Change from baseline (0) to 3 weeks
|
EQ5D5L scores
|
Change from baseline (0) to 3 weeks
|
|
The 5-level EQ-5D version (EQ-5D-5L) (0-5 scale)
Time Frame: Change from 3 weeks to 7 mothns
|
EQ5D5L scores
|
Change from 3 weeks to 7 mothns
|
|
EQ5D VAS (0-100 scale)
Time Frame: Change from baseline (0) to 3 weeks
|
EQ5D Vas overall health
|
Change from baseline (0) to 3 weeks
|
|
EQ5D VAS (0-100 scale)
Time Frame: Change from 3 weeks to 7 months
|
EQ5D Vas overall health
|
Change from 3 weeks to 7 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient acceptable symptom state (yes/no)
Time Frame: Baseline
|
Patients are asked with a single question if their current symptom state is acceptable
|
Baseline
|
|
Employment status (yes/no/part time)
Time Frame: Baseline
|
Baseline
|
|
|
Employment status (yes/no/part time)
Time Frame: 7 months
|
7 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 25, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
July 30, 2025
First Submitted That Met QC Criteria
July 30, 2025
First Posted (Actual)
August 6, 2025
Study Record Updates
Last Update Posted (Estimated)
August 26, 2025
Last Update Submitted That Met QC Criteria
August 25, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-16-02-329-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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