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

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: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Other: Supervised exercise; Other: Patient education

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: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Cumulative Survival analysis (Kaplan-Maier survival curve)	Cumulative Survival analysis as time in days without surgery since inclusion	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Hip disability and Osteoarthritis Outcome Score (HOOS 2.0)	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)	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	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

Outcome Measure	Measure Description	Time Frame
Self-reported exercise pain (VAS-scale)	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	'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	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)	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	Isometric muscle strength (iMVC) will be collected for knee extensors, hip extensors, -flexors and hip abductors.	Baseline, 3 and 12 months
Physical performance battery	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	Reasons for poor compliance will be recorded.	3 months
Joint specific adverse events	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

• Sponsor: University of Southern Denmark
• Collaborators: Odense University Hospital; Vejle Hospital; Region of Southern Denmark; The Danish Rheumatism Association; Institute for Clinical Research, Denmark
• 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

Publications and helpful links

General Publications

• Jensen C, Roos EM, Kjaersgaard-Andersen P, Overgaard S. The effect of education and supervised exercise vs. education alone on the time to total hip replacement in patients with severe hip osteoarthritis. A randomized clinical trial protocol. BMC Musculoskelet Disord. 2013 Jan 14;14:21. doi: 10.1186/1471-2474-14-21.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: September 21, 2012
• First Submitted That Met QC Criteria: September 26, 2012
• First Posted (Estimate): October 2, 2012

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Osteoarthritis; Education; Hip replacement; Hip; Exercise Therapy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: S-20120109