Effect of Exercise as Non-surgical Treatments on Time to Total Hip Replacement Surgery (HipSPORT)

May 4, 2018 updated by: Carsten Jensen, University of Southern Denmark

The Effect of Education and Supervised Exercise vs. Education Alone on Time to Total Hip Replacement in Patients With Hip Osteoarthritis Considered Eligible for Surgery

The aim of this trial is to test the hypothesis that patients with severe hip osteoarthritis postpone time to hip replacement surgery following participation in a patient education and supervised exercise program when compared to patients receiving patient education alone.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hip replacements are performed at an increasing rate, also in younger and less disabled patients. Recent studies indicate non-surgical interventions being effective in reducing pain and disability also at later stages of disease when hip replacement is considered. Possible, non-surgical treatments can be used to postpone hip replacement. The effect of education and supervised exercise on time to hip replacement is largely unknown

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5200
        • Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark
      • Vejle, Denmark, 7100
        • Sector for Hip and Knee Replacement, Dept. of Orthopaedics, Vejle Hospital, Denmark

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 40 years and older
  • Indication for total hip arthroplasty
  • Residency within local municipal or willing to commute

Exclusion Criteria:

  • Inflammatory joint disease
  • Earlier ipsilateral proximal femur fracture
  • Hip pain < 3 months
  • Neuropathy or neuromuscular disease
  • Malignant disease
  • Diseases where a moderate level of physical exercise is contraindicated
  • Unable to speak or read Danish
  • Unable to participate for other reasons
  • Refuse to participate

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Supervised exercise and patient education
The entire duration of the intervention is 12 weeks, and consists of 24 sessions each lasting 60-70 minutes. Patients will receive two types of exercises, delivered on separate days. One type of exercise is individualized, goal-based neuromuscular training (NEMEX) in groups with progression guided by the patient's neuromuscular function (12 sessions). The other type of exercise is individualized, intensive resistance training (RT) in groups with each exercise progression guided by load (12 sessions).
Other: Supervised exercise
Patients in the exercise groups will receive two types of exercise, delivered on separate days. One type of exercise is individualized, goal-based neuromuscular training (NEMEX-TJR) in groups with progression guided by the patient's neuromuscular function. The other type of exercise is individualized, intensive resistance training (RT) in groups with each exercise progression guided by load. Each of the two types of exercise will be offered weekly during the 12 week intervention period in sessions lasting 60-70 minutes. Thus, the entire exercise intervention consists of 24 sessions
Other Names:
  • NEMEX-TJR and RT
Other: Patient education
The patient education program is designed to educate the patients about hip osteoarthritis during 3 sessions of 90 min. duration
Other Names:
  • BOA
Other: Patient Education
The patient education program is designed to educate the patients about hip OA during 3 sessions of 90 min. duration
Other: Patient education
The patient education program is designed to educate the patients about hip osteoarthritis during 3 sessions of 90 min. duration
Other Names:
  • BOA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cumulative Survival analysis (Kaplan-Maier survival curve)
Time Frame: one year
Cumulative Survival analysis as time in days without surgery since inclusion
one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Hip disability and Osteoarthritis Outcome Score (HOOS 2.0)
Time Frame: Baseline, 3 and 12 months
HOOS is patient-reported outcome measure with 5 subscales for pain, other symptoms, function in daily living, function in sport and recreation and hip related Quality of Life. A 5-point Likert-scale is used and converted into a 100-point scale with zero indicating the worst possible health (http://www.koos.nu).
Baseline, 3 and 12 months
University of California Los Angeles activity score (UCLA)
Time Frame: Baseline, 3 and 12 months
Physical activity levels in populations. UCLA is a 10-point likert scale recommended and used extensively in similar populations
Baseline, 3 and 12 months
Global perceived effect (GPE) score
Time Frame: 3 and 12 months
Patients will be asked to rate possible change in their pain, symptoms, ADL, sports and recreation, quality of life, level of physical activity since the initial administration (baseline) on a 7-point Likert-scale.
3 and 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported exercise pain (VAS-scale)
Time Frame: 3 months
Pain intensity using the VAS-scale. Participants will be followed for the duration of the exercise intervention (3 months) and be asked to rate pain intensity before and after each exercise session (total 24 sessions)
3 months
Exercise adherence
Time Frame: 3 months
'The extent to which a person's behavior corresponds with agreed recommendations from a health care provider' using no. of weeks, and no. of completed sessions
3 months
Cost-effectiveness analysis
Time Frame: 12 months
Cost-effectiveness analysis will be estimated as the ratio between cost of the intervention and the effect it produces. The total cost will be estimated from register-based costing of primary care, secondary care and patient's out-of-pocket costs (transportation expenses and time spent on transportation and receiving health care). Patient-reported values are weighted using Danish tariffs
12 months
General health status EuroQol (EQ-5D-5L)
Time Frame: Baseline, 3 and 12 months
The EQ-5D is a generic instrument for describing and valuing health. It is based on a descriptive system that defines health in terms of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression (http://www.euroqol.org)
Baseline, 3 and 12 months
Mechanical Muscle Function
Time Frame: Baseline, 3 and 12 months
Isometric muscle strength (iMVC) will be collected for knee extensors, hip extensors, -flexors and hip abductors.
Baseline, 3 and 12 months
Physical performance battery
Time Frame: Baseline, 3 and 12 months
Physical performance-based measures will include; 30 s chair stand (number completed), 20 meter fast-paced walk (time in (s)), 30 s single-leg knee bending (number completed), and timed up and go (time in sec.)
Baseline, 3 and 12 months
Poor compliance
Time Frame: 3 months
Reasons for poor compliance will be recorded.
3 months
Joint specific adverse events
Time Frame: 3 months
Joint specific adverse events will be determined as: 1) not attending a training session and/or ceasing training because of increased pain/problems in the index joint related to the training; and 2) self-reported exercise pain > 5 on the VAS-scale after training. The reasons for not attending a session due to pain/problems related to training or to other reasons will be recorded.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Odense University Hospital
Vejle Hospital
Region of Southern Denmark
The Danish Rheumatism Association
Institute for Clinical Research, Denmark

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carsten Jensen, PhD, Orthopedic Research Unit, Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark. Institute of Clinical Research, University of Southern Denmark, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S-20120109

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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