Trial document





This trial has been registered retrospectively.
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  DRKS00009239

Trial Description

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Title

Prehabilitation for patients with osteoarthritis of the hip or knee waiting for a total Joint replacement for hip or knee

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Trial Acronym

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URL of the Trial

https://www.asklepios.de/hamburg/sankt-georg/experten/endoprothetik/prehabilitation/

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Brief Summary in Lay Language

The level of pain and the range of movement after a knee or hip replacement depends on the painlevel and the range of movement before the operation (1). Some research has already been done to evaluate the efficacy of preoperative sport- or physiotherapy to increase the level of joint movement and to reduce painlevels. Unfortunately these studies have only low numbers of participants and are not that comparable.
Therefore we developed a study to examine whether a standardized preoperative training programme can improve painscores after primary hip- or kneereplacement in comparison to a control group (null hypothesis). Furthermore the development of the range of movement and the functional abilities strength, mobility and walking endurance are measured.

Participants in this study are people with osteoarthrosis of the knee or hip who are awaiting a total joint replacement. All patients that can walk at least 3 m, who can understand and speak the German language, who don`t suffer from Alzheimer disease or have other neurological or medical illnesses that impair the mobility in a stronger way are asked to join the project.
These patients are allocated in two groups. One that gets a standardised exercise-programme (Prehabilitation) and one that doesn’t.
These groups are all tested immediately after being planned for the operation, after 5 weeks (after the Prehabilitation-period or just after 5 weeks without having had the training), at 6 weeks, 3 months and 6 months after the operation.
All patients are being tested on pain, ability to conduct daily activities, quality of life, strength, endurance and fitness.

All operations are done by one single senior surgeon.

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Brief Summary in Scientific Language

The level of pain and the range of movement after a knee or hip replacement depends on the painlevel and the range of movement before the operation(1). In literature preoperative therapy concepts have shown to be potentially effective to increase and accelerate postoperative recovery after total joint replacements (2, 3).
In contrary different meta-analyses doubted many of these statements. Reasons for this were too small research groups, missing therapeutic validity and the lack of comparability (4, 5, 6). In direction a postal-surgical pain relief and rise of the postal-surgical range of motion could be proved.

Horstmann et al examined training programmes to treat osteoarthritis in hip-/knee patients without operating them (7,8) with good results. Hoogeboom et al (5) developed preoperative trainingprogrammes in particular for elderly and comorbid patients. Especially the recommandations in these papers adressing the validity of therapeutic studies were taken up designing our training programme (6). Huber et al (9) and Ageberg et al (10) developed a training programme based on neuromuscular exercises and conducted a check of validity proclaimed by Hoogeboom et al.
The Prehabilitation-project in our clinic is the first approach of a clinic in Germany to evaluate the effects of a special exercise and training programme preparing for hip and knee arthroplasty. We developed a training schedule based on neuromuscular exercises and the recommandations concerning validity made by Hoogeboom et al. The training level /-intensity is controlled by and adjusted with the Borg scale (strain feeling) and the Visual Analogue Scale (pain).

Aim: In a randomized, prospective, controlled and single-blinded study we aim to decrease VAS-Scores and increase the ROM.

Conversion of the project: all patients planned for a knee and hip arthroplasty meeting the inclusion-criteria are included. After a computer assisted randomization two groups are formed: The treatment group (prehabilitation) and a control group without presurgical treatment. All operations are done by one senior surgeon.
The training group will go through a 4-week standardized training programme based on a neuromusculare weight training (8 sessions medical training therapy, 4 sessions therapy in the pool) and a patient's education (30 min. physician, 30 min. sports-therapist).

Assessments are being conducted at the beginning of the programme (T1), at the end of the programme (T2), 6 weeks after the operation (T3), 3 months (T4) and 6 months (T5) after the operation.
The used assessment tools and questionnaires are: KOOS/HOOS (Knee / Hip injury and Osteoarthritis Outcome score), SF36, VAS (Visual Analogue Scale), TUG (Timed-Up-and-Go), Chair stand test, 6 min walking test, 40-m-walking test.

1. Lingard et al Predicting the Outcome of Total Knee Arthroplasty: (JBJS [Am] 2004 ; 86-A:2179-2186)
2 Ditmyer MM, Topp R, Pifer M (2002): Prehabilitation in preparation for orthopaedic surgery. Orthop Nurs 21: 43–51.
3 Huber et al. (2013): Effect of preoperative neuromuscular training on functional outcome after total knee replace-ment: a randomized-controlled trial. BMC Musculoskeletal Disorders 14:157: 1471-1474
4 Gill StD, McBurney H (2013): Does Exercise Reduce Pain and Improve Physical Function Before Hip or Knee Re-placement Surgery? A Systematic Review and Meta-Analysis of Randomized Controlled Trials, Archives of Physical Medicine and Rehabilitation 2013, 94:164-76
5 Hoogeboom TJ, van den Ende CH, van der Sluis G, Elings J, Dronkers JJ, et al.(2009) The impact of waiting for to-tal joint replacement on pain and functional status: a systematic review. Osteoarthritis Cartilage 17: 1420–1427.
6 Hoogeboom TJ, Oosting E, Vriezekolk JE, Veenhof C, Siemonsma PC, et al. (2012): Therapeutic Validity and Ef-fectiveness of Preoperative Exercise on Functional Recovery after Joint Replacement: A Systematic Review and Meta-Analysis. PLoS ONE 7 (5): e38031. doi:10.1371/journal.pone.0038031
7 Merk, J., Horstmann, T., Krauss, I., Danzinger, B., Ziegler, C., Belzl, H. (2005): Sporttherapie für Patienten mit Kniearthrose oder Knieendoprothese - Konzept, Inhalte und Evaluation der Tübinger Kniesportgruppen. Z. f. Physio-therapeuten 2005, 57(2), 262-273
8 Horstmann T, Heitkamp HC, Haupt G, Merk J, Mayer F, Dickhuth HH (2001): „Möglichkeiten und Grenzen der Sporttherapie bei Coxarthrose - und Hüftendoprothesen-Patienten“. Z Sportmed Dt 2001; 52: S. 274-278
9 Huber et al. (2013): Effect of pre-operative neuromuscular training on functional outcome after total knee replace-ment: a randomized-controlled trial. BMC Musculoskeletal Disorders 2013, 14:157: 1471-1474
10 Ageberg et al. (2010): Feasibility of neuromuscular training in patients with severe hip or knee OA: The individual-ized goal-based NEMEXTJR training program. BMC Musculoskeletal Disorders 2010, 11:126

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00009239
  •   2015/10/14
  •   [---]*
  •   yes
  •   Approved
  •   PV5047, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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Health Condition or Problem studied

  •   M16 -  Coxarthrosis [arthrosis of hip]
  •   M17 -  Gonarthrosis [arthrosis of knee]
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Interventions/Observational Groups

  •   The intervention group which takes part in a 4-week training programme. This programme consists of 8 sessions medical training therapy (60 minutes), 4 sessions therapy in the pool (30 min) and an education session with an orthopedic surgeon and a sports scientist (30 min. each). Assessments at the beginning and at the end of the training programme, 6 weeks as well as 3 and 6 months after surgery.
  •   control group: Assessments at the beginning of the programme and shorty before surgery, 6 weeks as well as 3 and 6 months after surgery. Neither treatment nor education.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Control group receives no treatment
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The knee and hip patients as well as the patients with and without training programme estimate their pain using the VAS before the intervention (and the beginning of the training programme) (t = 0), after the end of the training programme (t = 1) and after 6 weeks, 3 months and 6 months (t = 2, 3, 4) postal-surgically.
Two primary hypotheses are examined: comparison of the mean change of the pain sensation (t = 0 to t = 2) in the therapy (VAS20t) and the control group (VAS20k) for patients with hip TJR and for patients with knee TJR:
null hypothesis (H0): VAS20t = VAS20k
alternative hypothesis (H1): VAS20t ≠ VAS20k

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Secondary Outcome

Besides of the comparison of the pain reductions in two groups, the following research questions are examined:
1) Development of the values VAS (estimation of pain) over the time
2) Development of the ROM values (mobility of knee (extension und flexion) and hip (extension, flexion and abduction))
3) Investigation of the values of KOOS (questionnaire of knee specific quality of life), HOOS (questionnaire of hip specific quality of life), SF-36 (questionnaire of general quality of life), timed-up-and-go-test (mobility), chair stand test (strength of the legs) and 40 m (speed test) and 6 min walking tests (walking endurance)

Assessments are conducted before (t=0) and after ((t=1) the programme and 6 weeks (t=2), 3 (t=3) and 6 (t=4) months after surgery.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/08/10
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

osteoarthritis of the hip or knee

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Exclusion Criteria

Alzheimer's disease, dementia, disability to speak and understand German, serious neurological disorders, disability to walk at least 3 m

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Addresses

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    • Orthopädische Praxis Großhansdorf
    • Mr.  Dr. med.  Roel  van der Most 
    • Sieker Landstraße 122-124
    • 22927  Großhansdorf
    • Germany
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    • Orthopädische Praxis Großhansdorf
    • Mr.  Dr. med.  Roel  van der Most 
    • Sieker Landstraße 122-124
    • 22927  Großhansdorf
    • Germany
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    • Asklepios Klinik St. Georg Sporttherapie/ Abteilung für Frührehabilitation und physikalische Medizin
    • Ms.  Daniela  Oestreich 
    • Lohmühlenstraße 5
    • 20099  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Asklepios Proresearch
    • Ms.  Dagmar  Pilz 
    • Lohmühlenstraße 5
    • 20099  Hamburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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