Trial document





This trial has been registered retrospectively.
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  DRKS00000651

Trial Description

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Title

Efficacy of conservative treatment regime for hip osteoarthritis - Evaluation of the therapeutic exercise regime "Hipschool"

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Trial Acronym

Hipschool evaluation

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URL of the Trial

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Brief Summary in Lay Language

Osteoarthritis (OA) is a disease with a major impact on both, national economy and the patient himself (Bork et al. 2005). Patients suffer from pain and functional impairment in activities of daily live (Dawson et al., 2004; Reginster et al., 2002). Bodily pain and deficits in physical functioning are associated with a decrease of life quality. Conservative therapeutic interventions are important to reduce pain, and increase function and health-related quality of life (Sprangers et al., 2000). In this respect, physical therapy, physiotherapy and physical exercise programs are relevant and important therapeutic options, of which treatments that can be realized by the patient himself are preferable in comparison to passive therapies (ACR, 2000; Boehmer, 2001). The “Tuebinger Hipschool” comprising group and home based exercises is one possible option of exercise related therapies in the treatment of OA. It aims at reducing pain, improving physical functioning, increasing self-efficacy and allowing exchange of information and social contacts.
The aim of this study is to examine the efficacy of a 12-week intervention program “Tuebinger Hipschool” in comparison to ultrasound therapy, placebo-ultrasound, and no intervention in patients with hip OA. Patients must be able to walk without any walking-aids. Along the intervention period, patients are randomly assigned to one of the mentioned treatment groups. The “Tuebinger Hipschool” comprises group therapy once a week (60-90’) and home based exercise twice a week (each 30-40’). It implies strength training, training of postural control, cognitive (equip knowledge) and social aspects. Ultrasound and placebo-ultrasound is applied once a week (15’) in moving the transducer on the anterior, lateral and posterior aspect of the affected hip.
To evaluate efficacy of interventions, questionnaires are used to describe disease specific physical restraints and bodily pain, as well as health-related quality of life. Clinical gait analysis and tests to measure strength of hip muscles and postural control are further used in the context of the given study. All questionnaires and tests are conducted prior and after the 12-week intervention period. Four and nine month after the intervention period, patients will be contacted via phone call to answer to the previously described questionnaires.

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Brief Summary in Scientific Language

Osteoarthritis (OA) is a disease with a major impact on both, national economy and the patient himself (Bork et al. 2005). Patients suffer from pain and functional impairment in activities of daily live (Dawson et al., 2004; Reginster et al., 2002). Bodily pain and deficits in physical functioning are associated with a decrease of life quality. Conservative therapeutic interventions are important to reduce pain, and increase function and health-related quality of life (Sprangers et al., 2000). In this respect, physical therapy, physiotherapy and physical exercise programs are relevant and important therapeutic options, of which treatments that can be realized by the patient himself are preferable in comparison to passive therapies (ACR, 2000; Boehmer, 2001).
According to the European League against Rheumatism (EULAR) exercise therapy is effective in the treatment of knee OA. Yet it is not clear how an optimized training regime should be designed and what kind of exercises are the most effective (Jordan et al., 2003; Kettunen, Kujala, 2004). Evidence for the efficacy of an exercise intervention in hip OA has only been demonstrated in single cases (Fransen, 2003). Therefore the aim of this study is to evaluate the efficacy of a specific 12-week exercise regime “Tuebinger Hipschool” in terms of pain, physical functioning, and life quality, isometric strength of hip muscles, gait patterns, and postural control. It should further be evaluated if potential positive effects can be sustained over a longer period of time (3 and 9 month past intervention).
This trial is a monocentric, randomized controlled trial with repeated measures. Measures are taken directly prior (M1) and after (M2) the 12-week intervention period. Two follow-ups are conducted via phone call 3 and 9 month after the intervention period. Within this time period, patients are allowed to choose whatever treatment option they want.
Population includes patients with hip osteoarthritis according to the clinical definition of the American College of Rheumatology. Patients must be able to walk without any walking aids. Inclusion and exclusion criteria are checked in the context of a screening process. Final in-/exclusion is defined in the context of the clinical examination of the investigator.
Intervention groups:
• n=70: The “Tuebinger Hipschool” comprises group (1x/week, 60-90’) and home based exercises (2x/week, 30-40’) with elements of strength training and training of postural control. Group exercises further enhance social contacts and include cognitive elements to equip knowledge being related to hip OA. It aims at reducing pain, improving physical functioning, increasing self-efficacy and allowing exchange of information and social contacts.
• N=70: Control (no intervention)
• N=70: Placebo-ultrasound (1x/week, 15’): attention control
• N=7 (explorative design, reduced sample size): Ultrasound (1x/week, 15’)
Sample size was estimated for comparison of “Tuebinger Hipschool” versus Control. Effect size was defined as being equal to a clinical relevant change (M2 versus M1) of the primary outcome (Subscale pain of the SF36) (Angst et al., 2001).
Secondary outcomes include WOMAC and SF36, isometric strength of hip muscles, outcomes of clinical gait analysis, and postural control.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

Data were already shared and implemented in an international data base for exercise therapy in hip and knee OA (OA Trial Bank).
See: BMJ Open
2017;7:e018971. doi:10.1136/
bmjopen-2017-018971 and Prospero registration number CRD42017054049.

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Organizational Data

  •   DRKS00000651
  •   2011/03/08
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  •   yes
  •   Approved
  •   358/2010BO2, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

  •   M16 -  Coxarthrosis [arthrosis of hip]
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Interventions/Observational Groups

  •   Exercise therapy: Intervention period 12 weeks between M1 and M2.
    Number of subject in treatment arm 1: n=70.
    Contents of intervention: "Hipschool” comprises group therapy once a week (60-90’) and home based exercise twice a week (each 30-40’). It implies strength training, training of postural control, cognitive (equip knowledge) and social aspects.
  •   No intervention: Intervention period 12 weeks between M1 and M2.
    Number of subject in treatment arm 2: n=70.
    Contents of intervention: No intervention.
  •   Placebo (sham ultrasound): Intervention period 12 weeks between M1 and M2.
    Number of subject in treatment arm 3: n=70.
    Contents of intervention: Sham ultrasound is applied once a week (15’) in moving the transducer on the anterior, lateral and posterior aspect of the affected hip.
    Sham ultrasound serves as attention control.
  •   Ultrasound: Intervention period 12 weeks between M1 and M2.
    Number of subjects in treatment arm 4: n=7 (explorative design, reduced sample size). Contents of intervention: Ultrasound is applied once a week (15’) in moving the transducer on the anterior, lateral and posterior aspect of the affected hip.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Placebo, Control group receives no treatment, Other
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

Subscale Pain SF36. M2 versus M1. Comparison of Hipschool versus no intervention.

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Secondary Outcome

M1 +M2 + M3 + M4: The 36-item Short Form (SF36) is a well-established generic health status measure. It comprises different scales, four of them related to physical health (physical functioning, role-physical, bodily pain, general health), and four of them related to mental health (vitality, social functioning, role-emotional, mental health). Another question is related to the actual health status. All scales and sum scores will be analysed as secondary outcomes at each measurement day M1-M4 (apart from bodily pain M2 versus M1 as being the primary outcome criteria).

M1 +M2 + M3 + M4: The Western Ontario McMasters Universities Osteoarthritis Index (WOMAC® NRS German for Germany 3.1 Index) is a disease specific instrument used to evaluate self-reported pain, stiffness and functional impairment. All scales and sum scores will be analysed as secondary outcomes at each measurement day M1-M4.

M2 + M3: A five point Likert Scale will be used on M2 and M3 to quantify satisfaction with the therapy regime, and whether participants would recommend this therapy to others.

Monthly logbooks between M1 and M2, and at M3 and M4 (M3 and M4 in the context of the telephone interview): Participants are asked to fill out a monthly logbook between M1 and M2. They have to specify previous physiotherapy and/or exercise, medication, and pain (retrospective time frame of four weeks, or to the last measurement day (M2 for M3, M3 for M4)).

M1 + M2: Postural control will be quantified in bi-pedaled, tandem-, and single leg stance on a measuring system for force distribution (FDM System, zebris Medical GmbH, Isny, Germany). The outcome measure for postural control is the total path of the centre of force over the entire trial.

M1 + M2: Participants will undergo three-dimensional gait analysis in barefoot and shod condition at self-selected normal speed. Kinematic and spatial-temporal data will be collected using a Vicon motion analysis system with six cameras (ViconPeak, MCAM M1, 120 Hz, Oxford, UK). Data will be analysed with the lower body model of the conventional gait model Plug-in-Gait (Vicon Polygon, Oxford Metrics Ltd., Oxford, UK). Outcome measures will include the following spatial-temporal variables: stride length, step length, step width, walking velocity, cadence, single- and double support time. Other variables of interest will include time histories; maximum and minimum joint angles, and ranges of motion of the sagittal plane for hip, knee, and ankle joint, as well as pelvic drop and Hip ab-adduction iin the frontal plane.

M1 + M2: Functional tests
Pelvic obliquity, passive ranges of motion of the hip, knee and ankle joint and muscular flexibility of the M. iliopsoas, M. rectus femoris and the hamstrings will be examined by a physiotherapist.

M1 + M2: Isometric strength measures
The Isomed 2000 (D&R GmbH, Hernau, Germany) isokinetic dynamometer will be used to measure isometric peak torque for hip abduction (HAB), hip adduction (HAD), hip flexion (HF) and hip extension (HE).


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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2010/08/20
  •   220
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
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Additional Inclusion Criteria

• Age 18 – 85 years
• Hip OA in one or both hip joints according to the clinical classification of the American College of Rheumatology
• Informed consent of the subject
• Sufficient time to keep therapeutic appointements
• Health related eligibility in terms of physical and emotional ability.
• Capacity to consent
• Subjects can also be included in case of a contra-lateral hip replacement, as long as one side has a hip osteoarthritis according to the above mentioned criteria

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Exclusion Criteria

• Instable anchoring of a potential artificial hip replacement
• Previous luxation as an adverse event in case of an artificial hip replacement
• Pathologies in the region of the lower extremities or lower back that are not related to OA and need medical treatment (healthy practitioners of medical doctors)
• Abuse of drugs or alcohol
• Participation in another clinical trial in the last 4 weeks
• No Compliance
• Acute illness
• Use of walking-aids
• Previous trauma at the hip or pelvis with subsequent development of a secondary arthrosis
• Known endocrinologic cause of hip OA
• Verified metabolic cause of hip OA
• State after aseptic osteonecrose
• Cardio-vascular disease or other co-morbidities resulting in a profoundly decreased physical capacity in every day live and known as contraindication for physical activities (i. e. cardiac insufficiency NYHA III-IV, terminal renal insufficiency state IV).
• Medical exercise therapy, and physiotherapy using weight machines and comparable resources in the last three month, being carried out at least 6 times.
• Specific group or individual intervention to address OA in the last 3 month (Minimum 1x/week 30‘ or more)
• Physical therapy to address OA (Minimum 1x/week)
• Novel initiated physical exercise within the last 3 month (Minimum 1x/week to be short of breath for at least 30’)
• Corticoid injection into the hip joint within the last 12 month

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Addresses

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    • Medizinische Universitätsklinik Tübingen, Abteilung Sportmedizin
    • Ms.  Prof Dr.  Inga  Krauß 
    • Hoppe-Seyler-Str. 6
    • 72076  Tübingen
    • Germany
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    • Medizinische Universitätsklinik Tübingen, Abteilung Sportmedizin
    • Ms.  Prof. Dr.  Inga  Krauß 
    • Hoppe-Seyler-Str. 6
    • 72076  Tübingen
    • Germany
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    • Medizinische Universitätsklinik, Abteilung Sportmedizin
    • Ms.  Prof. Dr.   Inga  Krauß 
    • Hoppe-Seyler-Str. 6
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Universitätsklinik Tübingen, Abteilung Sportmedizin
    • Silcherstrasse 5
    • 72076  Tübingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/01/22
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Trial Publications, Results and other Documents

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