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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Southern Denmark
Sponsor:
Collaborators:
Orthopedic Research Unit, Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital
Institute for Clinical Research, Denmark
Vejle Hospital
Region Southern Denmark
Odense University Hospital
The Danish Rheumatism Association
Information provided by (Responsible Party):
Carsten Jensen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01697241
First received: September 21, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Osteoarthritis
Other: Supervised exercise
Other: Patient education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Cumulative Survival analysis (Kaplan-Maier survival curve) [ Time Frame: one year ] [ Designated as safety issue: No ]
    Cumulative Survival analysis as time in days without surgery since inclusion


Secondary Outcome Measures:
  • The Hip disability and Osteoarthritis Outcome Score (HOOS 2.0) [ Time Frame: Baseline, 3 and 12 months ] [ Designated as safety issue: No ]
    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).

  • University of California Los Angeles activity score (UCLA) [ Time Frame: Baseline, 3 and 12 months ] [ Designated as safety issue: No ]
    Physical activity levels in populations. UCLA is a 10-point likert scale recommended and used extensively in similar populations

  • Global perceived effect (GPE) score [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Self-reported exercise pain (VAS-scale) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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)

  • Exercise adherence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    '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

  • Cost-effectiveness analysis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

  • General health status EuroQol (EQ-5D-5L) [ Time Frame: Baseline, 3 and 12 months ] [ Designated as safety issue: No ]
    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)

  • Mechanical Muscle Function [ Time Frame: Baseline, 3 and 12 months ] [ Designated as safety issue: No ]
    Isometric muscle strength (iMVC) will be collected for knee extensors, hip extensors, -flexors and hip abductors.

  • Physical performance battery [ Time Frame: Baseline, 3 and 12 months ] [ Designated as safety issue: No ]
    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.)

  • Poor compliance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Reasons for poor compliance will be recorded.

  • Joint specific adverse events [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: March 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: BOA
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 Name: BOA

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697241

Contacts
Contact: Carsten Jensen, PhD cjensen@health.sdu.dk
Contact: Søren Overgaard, Prof. Soeren.Overgaard@ouh.regionsyddanmark.dk

Locations
Denmark
Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark Not yet recruiting
Odense, Denmark, 5200
Contact: Carsten Jensen, PhD       cjensen@health.sdu.dk   
Contact: Annie G Pedersen, Project Nurse       Annie.Gam-Pedersen@ouh.regionsyddanmark.dk   
Principal Investigator: Carsten Jensen, PhD         
Sector for Hip and Knee Replacement, Dept. of Orthopaedics, Vejle Hospital, Denmark Recruiting
Vejle, Denmark, 7100
Contact: Per K. Andersen, Clinical Ass. Prof.       pka@dadlnet.dk   
Contact: Jane S. Leonhardt, Project nurse       jane.schwartz.leonhardt@slb.regionsyddanmark.dk   
Sub-Investigator: Per K. Andersen, Clinical Ass. Prof.         
Sponsors and Collaborators
University of Southern Denmark
Orthopedic Research Unit, Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital
Institute for Clinical Research, Denmark
Vejle Hospital
Region Southern Denmark
Odense University Hospital
The Danish Rheumatism Association
Investigators
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
  More Information

No publications provided by University of Southern Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carsten Jensen, Assistant Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01697241     History of Changes
Other Study ID Numbers: S-20120109
Study First Received: September 21, 2012
Last Updated: June 18, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by University of Southern Denmark:
Exercise Therapy
Education
Osteoarthritis
Hip
Hip replacement

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014