Trial document




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  DRKS00023269

Trial Description

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Title

Randomized controlled study in a wait-list control design to evaluate a 12-week app- and orthesis-supported training intervention in patients with moderate to severe knee osteoarthritis

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Trial Acronym

AppExOA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Osteoarthritis (OA) is considered the most common degenerative joint disease worldwide. More than half of those affected in Germany suffer from knee arthrosis. With increasing severity of the disease patients report pain, restrictions in physical function and a reduced quality of life. National and international guidelines recommend sports and exercise therapy as a conservative core treatment strategy. Up to now, this has mainly been implemented by means of group and physiotherapeutic guided exercise sessions. However, in the course of progressive digitalization, the demand for app-supported products to guide exercises is increasing and the effectiveness and safety of such products needs to be investigated. Beside exercise as a core treatment for OA, the use of knee orthoses has also shown positive results in the treatment of osteoarthritis.
The main objective of this study therefore is to investigate the effectiveness and safety of a 12-week app-supported exercise intervention in comparison to a control group without intervention. The exercise intervention will be evaluated for the use of the stand-alone app as well as in combination with a knee orthosis.
The training intervention includes a program of exercises for mobilization, stretching, strengthening and balance, which are instructed by the app. Movement quality and quantity are controlled by accelerometers. The study will be conducted on 60 subjects with moderate to severe knee osteoarthritis.

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Brief Summary in Scientific Language

The present study is a randomized controlled study in a waiting list design. The study is designed to test an app-based exercise program for patients with moderate to severe medial or lateral knee osteoarthritis. The intervention is a 12-week home exercise program, which is guided by a digital app and includes a progressive video-supported training program with exercises to improve mobility, flexibility, strength and balance. Movement range and speed as well as the number of repetitions are controlled and documented by accelerometer and visualized as biofeedback in the app. One study arm just uses the app and accelerometers, the other study arm combines this with a correcting knee orthosis. The control group does not receive a study intervention. The primary endpoint is the joint comparison of the two App study arms with regard to osteoarthritis-specific symptoms (Knee Osteoarthritis Outcome Score) in contrast to the waiting list control group. Subsequently, a differentiation into app versus app and orthosis is performed. Other study endpoints include self-declaration of health-related quality of life (VR12), fear of movement and sports and physical activity (EHIS-PA). Objective measures include maximum force measurement for knee flexors/extensors, testing of leg strength and strength endurance (30-second chair test), and balance tests (course of the center of pressure during bipedal, one-legged, and tandem stands). During the intervention, the sensation of exertion while exercising, the quality and quantity of exercise performance, training adherence and the recording of safety aspects during the intervention (pain, unexpected events or side effects) are also recorded.

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

No

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Description IPD sharing plan:

The anonymized public provision of the data is currently not planned. Inquiries should be addressed personally to the study centre.

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Organizational Data

  •   DRKS00023269
  •   2020/10/09
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  •   yes
  •   Approved
  •   550/2020BO, 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

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

  •   App-guided exercise intervention (12 weeks)
  •   App-guided exercise intervention by use of an knee orthosis (12 weeks)
  •   Control without study intervention (12 weeks) then randomized allocation (1: 1) inApp-guided exercise intervention (12 weeks) or App-guided exercise intervention by use of an knee orthosiss (12 weeks)
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Characteristics

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

The primary endpoint is the joint comparison of the two App study arms with regard to osteoarthritis-specific symptoms (Knee Osteoarthritis Outcome Score) in contrast to the waiting list control group immediately before and after the 12-week intervention phase.

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Secondary Outcome

Other study endpoints include self-reporting on health-related quality of life (VR12), fear of movement (Brief Tampa Skale of Kinesiophobia) and sports and physical activity (EHIS-PA). Objective measures include maximum force measurement for knee flexors/extensors, testing of leg strength and strength endurance (30-second chair test), and balance tests (course of the centre of pressure (COP) during bipedal, one-legged and tandem stands). During the intervention, the sensation of exertion during training, the quality and quantity of exercise performance, training adherence, and the recording of safety aspects during the intervention (pain, unexpected events or side effects) are also recorded.
The evaluation also takes into account a differentiation into app versus app and orthosis as well as the analysis of follow-up time points 24 weeks after baseline.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/10/12
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Osteoathritis symptoms are primary located at the knee joint; unicondylar knee osteoarthritis; moderate to severe knee osteoarthrititis (KOOS <=60 where 100 indicates no complaints at all); good German language skills (Information sheet, questionnaires); Willingness to wear the orthosis while exercising, Willingness to use the app to exercise, access to a device with iOS operating system.

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Exclusion Criteria

Scheduled elective knee joint replacement; already implanted artificial joint; osteoarthritis primarily in the hip joint or others than the knee; diffuse pain; solely retropatellar knee osteoarthritis; Complaints that affect physical performance in everyday life, measured by use of the PAR-Q, verified by the physician, if applicable; Complaints located at the back or lower extremities that are currently treated by a medical doctor or health professional; previous surgeries, injuries or complaints that may impair measures of strength and balance or the exercise intervention itself.

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Addresses

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    • Universitätsklinikum Tübingen Abt. Sportmedizin
    • Hoppe-Seyler-Str. 6
    • 72076  Tübingen
    • Germany
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    • Kineto Tech Rehab SRL; Re.flex
    • Mr.  Camil  Moldoveanu 
    • Bukarest
    • Romania
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    • Firma Sporlastic GmbH
    • Mr.  Dr.  Timo  Schmeltzpfennig 
    • 72622  Nürtingen
    • Germany
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    • Universitätsklinikum TübingenAbt. Sportmedizin
    • Ms.  Prof. Dr.  Inga  Krauß 
    • Hoppe-Seyler-Str. 6
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum TübingenAbt. Sportmedizin
    • Ms.  Valerie  Dieter 
    • Hoppe-Seyler-Str. 6
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Sporlastic GmbH
    • Mr.  Dr.  Timo  Schmeltzpfennig 
    • 72622  Nürtingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
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  •   2021/04/26
  •   61
  •   61
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.