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Completed

NCT Number: NCT01697241

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

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark, Odense, Denmark

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supervised Exercise

Other

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

Patient Education

Other

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

Other names: BOA

Primary outcomes

  1. Cumulative Survival analysis (Kaplan-Maier survival curve)

    Time frame: one year

    Cumulative Survival analysis as time in days without surgery since inclusion

Secondary outcomes

  1. 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).

  2. 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

  3. 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.

Other outcomes

  1. 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)

  2. 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. 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

  4. 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)

  5. 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.

  6. 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.)

  7. Poor compliance

    Time frame: 3 months

    Reasons for poor compliance will be recorded.

  8. 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.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

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

Registry information

Official study 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

Acronym: HipSPORT

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 2, 2012
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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