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

Osteoarthritis Clinical Trial

— HipSPORT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697241
• Other study ID #: S-20120109
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: August 2017

Study information

• Verified date: May 2018
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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
• Patient education
The patient education program is designed to educate the patients about hip osteoarthritis during 3 sessions of 90 min. duration

Locations

Country	Name	City	State
Denmark	Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark	Odense
Denmark	Sector for Hip and Knee Replacement, Dept. of Orthopaedics, Vejle Hospital, Denmark	Vejle

Sponsors (7)

Lead Sponsor	Collaborator
University of Southern Denmark	Institute for Clinical Research, Denmark, Odense University Hospital, Orthopedic Research Unit, Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Region of Southern Denmark, The Danish Rheumatism Association, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	Mechanical Muscle Function	Isometric muscle strength (iMVC) will be collected for knee extensors, hip extensors, -flexors and hip abductors.	Baseline, 3 and 12 months
Other	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
Other	Poor compliance	Reasons for poor compliance will be recorded.	3 months
Other	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
Primary	Cumulative Survival analysis (Kaplan-Maier survival curve)	Cumulative Survival analysis as time in days without surgery since inclusion	one year
Secondary	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
Secondary	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
Secondary	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