Instructions for Use for the digital health application (DiGA) “Vivira”

Therapeutic training at home
for back, knee and hip pain

You can read the sections by clicking on the respective heading.

The Vivira App (“App”) is a therapeutic training program for back, knee and hip pain. The App addresses users with non-specific lower back pain, osteoarthritis of the spine (osteochondrosis), osteoarthritis of the knee (gonarthrosis), non-specific knee pain, osteoarthritis of the hip (coxarthrosis) and non-specific hip pain.

The App can be used with or without prescription by a medical doctor. It offers, e.g., personalized, and therapeutic training content that adapts based on user feedback, the possibility to track training activity and the development of the disease, the possibility to test movement capabilities, and educational content regarding the health of the musculoskeletal system.

These Instructions for Use describe the intended use of the App.

Before use, a medical doctor should have confirmed that Vivira is suitable for you and your special health situation.

Vivira does not offer a medical or therapeutic diagnosis, recommendation, or medical treatment.

Read these Instructions for Use carefully and completely before using Vivira. Please pay particular attention to the following sections:

  • Section 2: Legal requirements for the use, processing of your data
  • Section 3: Technical and medical requirement for use and contraindications
  • Section 4: Safety instructions and side effects

Training with Vivira can be carried out without supervision by a doctor or therapist.

Dose
Unless otherwise instructed by a medical doctor, you should conduct your Vivira training daily, with four exercises per day, but at least 3 days a week.

Duration of use
The duration of use depends on the type of complaint and / or duration of the illness and is therefore only determined by your doctor. Die duration of use is often approximately 3 months.

Image sections from the App used in the Instructions for Use show screens as they would appear on devices from the manufacturer Apple. Screens on devices that use the Android operating system may differ slightly.

Questions can be asked at service@vivira.com at any time.

As a prerequisite for the use, you confirm at the start of the introduction that you

  • are at least 18 years old
  • have read and accept the Vivira Terms and Conditions
  • have read and accepted the Vivira Data Privacy Policy and consent to the processing of your personal health data by Vivira.

The purpose of data processing is to support you in optimally conducting therapeutic training at home, as a complement to other treatment forms, while helping you as best possible in reducing your knee-, hip-, or back-pain. This includes the clinical validation of our product by research organizations using anonymized data.

You can withdraw your consent to the processing of your data at any time in the Vivira App under Profile > Settings > Manage your data.

3.1. Technical requirement for use

Vivira is currently compatible with operating systems from Android 6.0 and from iOS 11.0 onward. To fully use Vivira, users need to continually update their software, incl. browser technology and operating systems on their devices. Certain activations may be required (e.g., Java Script). If older software or software that is not in general use is used, it is possible that the user will only be able to use Vivira’s services to a limited extent or not at all.

An application without a stable broadband internet connection is not possible.

3.2. Medical requirement for use

Vivira should only be used if none of the following contraindications are present, unless you have received a medical clarification from a doctor who considers physical exercises such as those used in the Vivira app to be harmless in your particular case:

Acute inflammation or fever
Do not use the Vivira App if you have an acute inflammation or fever.

Slipped disc or sensorimotor disorders
Do not use the Vivira app if you have or have had a slipped disc or sensomotoric complaints. In addition to the herniated disc, this includes numbness or weakness in your legs, loss of sensation in the genital area as well as bowel or bladder incontinence.

In neurological treatment
Do not use the app if you are being treated for a stroke, paralysis, MS or convulsions.

Previous spine surgery
Do not use the Vivira app if you have already undergone spinal surgery.

Previous hip or knee surgery
Do not use the Vivira app if you have had surgery on your knee or hip in the past, especially if you have received a new joint or your leg axis has been corrected.

Possible injuries of the spine, spinal cord, knee or hip joint
Do not use the Vivira app if your pain is caused by a fall or other physical injury and has not been medically examined to rule out injuries to the spine, the spinal cord or the affected joint.

Spinal or joint infection
Do not use the Vivira app if you have been diagnosed in the past with an infection in the area of the spine, hip or knee joint.

Spinal tumor
Do not use the Vivira app if you have a medical history of spinal tumor, cancer, excessive night sweats, unexplained weight loss and/or unexplained fatigue.

Free joint bodies
Do not use the Vivira app if you have a free joint body in the knee or hip joint or if osteochondrosis dissecans or bone necrosis is known.

Advanced heart disease
Do not use the Vivira app if you have or have had a history of heart disease, shortness of breath after climbing stairs for less than 2 floors or other unresolved cardiovascular problems (e.g. palpitations, unexplained swelling of the legs, coughing).

Rheumatic disease
Do not use the Vivira app if you suffer from a known rheumatic disease.

Reduced bone density
Do not use the Vivira app if you have a known low bone density (age-related bone loss or other medical reasons).

Unsteady gait or frequent falls
Do not use the Vivira app if you have an unsteady gait, frequent falls, low blood pressure or dizziness caused by exercise.

Bleeding tendency, history of increased bleeding or anti-coagulant therpay
Do not use the Vivira app if you suffer from increased bleeding, a hereditary bleeding disorder, or are taking anti-coagulant medication.

Pregnancy
Do not use the Vivira app if you are pregnant or think you might be pregnant.

Lung failure
Do not use the Vivira app if you suffer from lung failure.

Thrombosis
Do not use the Vivira app if you are being treated for thrombosis.

Psychosis
Do not use the Vivira app if you are being treated for psychosis.

Skin sensitivity disorder
Do not use the Vivira app if you suffer from a skin sensitivity disorder.

Large skin defects or severe burns
Do not use the Vivira app if you are or recently were hospitalized for large skin defects or severe burns.

3.3. Accessibility

The App is not barrier-free and therefore not suitable for users with visual impairments.

4.1. Safety instructions

Attention! Always follow your doctor’s instructions regarding the exercises and movements you are allowed to do in your particular health situation. Your doctor’s instructions are always above the instructions in the app and must always be followed exactly. Failure to follow your doctor’s instructions when using Vivira can result in pain and injury.

Attention! Before carrying out an exercise, always pay close attention to the exercise instructions in the instruction video and always read the explanatory texts under the instruction videos. They contain important information for the correct execution of the exercises. If you are not sure how to do an exercise, stop and ask your doctor or therapist. Although the exercises have been selected to be suitable for home exercise without a doctor or therapist present, doing the exercises incorrectly can cause pain and injury.

Attention! Always answer the questions that are asked by the App carefully and truthfully, especially regarding your complaint area, medical indications, movement limitations, pain, and the ability to do all repetitions of an exercise. Providing inaccurate or incorrect information in the Vivira App can lead to you getting exercises that are not suitable for you. Performing such exercises can cause pain or injury.

Attention! Individual exercises require positions in a quadruped position (on all fours) and lying down. If you have difficulty getting up after taking these positions, you should not do these exercises.

4.2. Specific information and warnings

Non-specific back pain

  • Information: Especially back pain is often related to stress, movement and lack of sleep. One speaks then of unspecific back pain. Select “Non-specific back pain” from the list of medical indications in the App, only if you…
    • do not feel any radiations in the legs
    • do not have a slipped disc
    • do not have scoliosis
  • Warning: If you have severe back pain, you should pause your training and consult a physician.

Hip arthrosis, knee arthrosis, arthrosis of the back (osteochondrosis)

  • Information: Osteoarthritis is a degenerative change in the cartilage that covers the joint surfaces. Colloquially one speaks also of “joint wear and tear”. Osteoarthritis is characterized by pain and restricted movement in the joint, and is often associated with morning stiffness, which improves with movement.
  • Warning: Movement often helps with osteoarthritis pain, which can sometimes be weaker and sometimes stronger. Start the training slowly so that you do not overstrain yourself. Reduce the intensity of the training or skip painful exercises if your pain persists.

Non-specific knee pain

  • Information: This category includes knee pain caused by overloading or incorrect loading of the knee.
  • Warning: If you have severe pain, the affected area is swollen or warm, you should pause your training and consult a physician.

Non-specific hip pain

  • Information: This category includes hip pain caused by overloading or incorrect weight bearing of the hip.
  • Warning: If you have severe pain, the affected area is swollen or warm, you should pause your training and consult a physician.
4.3 Side effects

Side effects are undesirable effects that can occur when the App is used as intended.

Which side effects may occur?

  • Temporary, slight pain due to excessive strain on joints, muscles or tendons

Reported side effects, which occurred in at least one of 50,000 Vivira installations, were taken into account for the information at this point. No other side effects were known to us at the time of writing these Instructions for Use.

Other possible side effects, although none have been reported to us by users:

  • Pain in legs, knees, backs of hands
  • Ischia-like pain in the area of the lumbar spine due to irritation of the nerve exit points from the spine
  • Irritant states of the joints with impaired function
  • Swelling
  • Itchiness
4.4 Reporting undesirable effects

If you notice an undesirable effect when using Vivira (e.g. a discomfort or a change), send us a message directly from the App (Profile> Settings> Send us a message) or an email to service@vivira.com. You can also contact a doctor or pharmacist to report an undesirable effect.

Vivira is based on movement therapy.

“Movement therapy is a method of physiotherapy to increase resilience and restore normal body function through systematic and individually adapted physical exercises”. (translated from Pschyrembel Klinisches Wörterbuch)

Movement therapy is part of the guidelines for the treatment of non-specific back pain (non-specific low back pain), knee arthrosis (gonarthrosis) and hip arthrosis (coxarthrosis) and is therefore a recognised professional standard. Furthermore, the positive effect of exercise therapy on pain reduction has been scientifically proven.

As part of the movement therapy, Vivira addresses mobility, stability (strength) and coordination through regular exercising at home. “Mobility is the combination of muscle flexibility and the range of motion of the joint, both together define the mobility of a body part. (…) Stability describes the preservation of posture and the control of fundamental movements. It therefore requires strength in different joint positions, at different speeds of movement and combinations of these. (…) Coordination, or proper neuromuscular control, is the third essential pillar for movement. This refers to the ability of our brain to initiate a movement and to control its progress.” (translated from Klingenberg 2019)

The Vivira exercises were selected according to a functional training approach. They usually affect several joints and muscle groups, i.e. they follow the principle of regional inter-dependencies and related muscle chains. The Vivira training thus pursues a holistic therapy approach to strengthen the body in its entire range of motion.

You can find further literature references on the therapy concept in the Vivira App in the “Knowledge” Section under “Vivira therapy concept”.

In the Onboarding of the App you answer, among other questions, questions about yourself, your area of ​​complaint, your medical indications, and your movement limitations. Your training program is configured from this information.

Shortly before the introduction ends, the app prompts you to enter your email address and a password of your choice to set up your Vivira account. We need your email address so that we can contact you in the event of important product safety issues. Vivira will never share your email address with third parties or use it for advertising purposes. Please use a secure password that is only known to you and that consists of at least 8 characters, including at least one small and one large cap letter, and at least one number.

As soon as you have completed the Onboarding including setting up your Vivira account, you can use the Vivira App for therapeutic training!

7.1. Basics

After setting up your Vivira account, you will receive 4 exercises a day in the App. After each exercise, you give feedback on whether the exercise caused or intensified pain and whether you could do all repetitions. According to your statements, the exercises for the next day change in intensity and complexity.

Interrupt an exercise if it causes or worsens pain or if you notice a loss of function. See a doctor if these symptoms persist.

7.2. Access via the Today page

Access the exercises on the Today page in the App by tapping the exercise card.

By swiping up and down you can see the four daily exercises. By tapping the orange triangle you start the respective exercise preview.

7.3. Exercise preview

Carefully follow the explanation of how to perform the exercise in the exercise preview video. Also read the explanation below the video. As soon as you are familiar with the correct exercise execution, tap on “Start exercise”.

7.4. Performing the exercise

Perform the exercise with the number of sets and repetitions or holding for the number of seconds specified here. As soon as you are finished, tap on “Done”.

7.5. Feedback after the exercise

After completing the exercise, answer questions about pain and your ability to fully complete the exercise.

Discontinue an exercise if it causes or worsens pain or if you notice a loss of function. See a doctor if these symptoms persist.

If you answer that there was pain, you have the option to remove the respective exercise from your program.

Your details determine whether the intensity and complexity of the exercise will increase next time.

7.6. Exercise history

You can see the history of your exercises on the Activity page of the App.

8.1. Basics

The App prompts you every week to complete a Wellbeing Journal with seven questions about pain, limitations and your therapeutic treatment.

8.2. Access via the Today page

You can access the Wellbeing Journal via the Today page in the App by tapping the Wellbeing Journal card.

8.3. Answering the questions

The questions will be asked to you in the form of a written dialogue. You provide information by activating a slider and by providing yes / no answers.

9.1. Basics

The App asks you monthly to perform a Movement Test with 15 movements. With your information after each movement, a movement score is calculated.

9.2. Access via the Today page

You can access the Movement Test via the Today page in the App by tapping the Movement Test card.

9.3. Completion of the test

You will receive an illustration with an explanatory text for each movement. Try to perform the movement as directed.

You then answer the questions for each exercise as to whether you were able to perform the movement and whether you were in pain during the movement.

From your information, Vivira calculates a score for overall movement capability, as well as a individual scores for mobility, strength and coordination.

10.1. Basics

The App allows you to record your steps every day.

10.2. Access via the Today page

You can access the input area via the Today page in the App by tapping the field “Log steps”.

10.3. Log steps

You can log steps manually or have the steps automatically integrated into the Vivira app on Apple devices via integration with Apple Health.

11.1. Basics

Your daily training activity, your answers in the Wellbeing Journal, the scores of your Movement Tests as well as the daily steps are visually displayed in the App, so that you can track their progress over time at any time.

11.2. Activity

The Activity page in the App shows you the history of your activities in the form of a timeline with your exercises, Wellbeing Journals, Movement Tests, and steps.

11.3. Outcomes

The Outcomes page in the App shows you progress curves relating to the answers you have given regarding movement capabilities, pain, and limitations.

12.1. Basics

If you want to share important program and progress data with a doctor or therapist, you can generate a PDF file with this data from the App. You can then print out the PDF file and present it to your doctor.

12.2. Access via the Profile page

On the Profile page, tap on “Export your data”.

12.3. Create a Progress Report

Tapping on “Create report” opens a written dialogue in which you are asked questions about pain and your therapeutic treatment. After answering the questions, the App automatically creates a Progress Report PDF file with your most important program and progress data.

12.4. Send Progress Report

You can send your Progress Report by tapping the share icon in the top right of the screen. The various applications in which you can share your report then open in your device.

Vivira explicitly does not recommend that you share your personal health data on, e.g., social media. Share your personal health data only in applications that guarantee the legally required level of data protection and data security, in which you know the recipient group and in which you can determine exactly who the recipient(s) of your data will be.

13.1. Basics

In addition to the training, you can read Insights articles on topics related to musculoskeletal health in the App to support the training effect.

13.2. Access via the Today page

You can access the Insights articles via the Today page in the App by tapping the Insights card.

13.3. Read the Insights articles

By swiping up and down as well as left and right, you get an overview of the available articles. These cover subject areas such as “About Vivira” and “Posture and Movement”.

14.1. Basics

You can change your program settings at any time on the Profile page and under Settings.

14.2. Access via the Profile page

You can find the Settings by tapping “Settings” on the top right of the Profile page.

14.3. Change of Settings

In the Settings you can make a variety of changes to optimize your Vivira experience, to send us a service request or to recommend Vivira. Here you can set your notifications, switch your Apple Health Integration on and off, and change your password. You can also manage your data here or log out of the app so that it will be accessible only once you log in again.

At the start of your training with Vivira, read in particular the knowledge articles “About Vivira” in the top row of knowledge articles. These give you a basic understanding of the Vivira training philosophy and a suitable weekly schedule. They also give tips on what can be done if exercises are either too difficult for you or are challenging you.

BeschwerdebereichIndikationsgruppeICD 3 StellerBezeichnungICD 4 StellerBezeichnung
RückenNicht-spezifischer KreuzschmerzM53.-Sonstige Krankheiten der Wirbelsäule und des Rückens, anderenorts nicht klassifiziertM53.2Instabilität der Wirbelsäule
M53.8Sonstige näher bezeichnete Krankheiten der Wirbelsäule und des Rückens
M53.9Krankheit der Wirbelsäule und des Rückens, nicht näher bezeichnet
M54.-RückenschmerzenM54.5Kreuzschmerz – Inkl.: Lendenschmerz; Lumbago o.n.A.; Überlastung in der Kreuzbeingegend – Exkl.: Flankenschmerz-Hämaturie-Syndrom (N39.81); Lumbago durch Bandscheibenverlagerung (M51.2); Lumboischialgie (M54.4)
M54.6Schmerzen im Bereich der Brustwirbelsäule – Exkl.: Schmerzen durch Bandscheibenschaden (M51.-)
M54.8Sonstige Rückenschmerzen
M54.9Rückenschmerzen, nicht näher bezeichnet – Inkl.: Rückenschmerzen o.n.A.
M99.0Segmentale und somatische FunktionsstörungenM99.02Segmentale und somatische Funktionsstörungen : Thorakalbereich [thorakolumbal]
M99.03Segmentale und somatische Funktionsstörungen : Lumbalbereich [lumbosakral]
M99.04Segmentale und somatische Funktionsstörungen : Sakralbereich [sakrokokzygeal, sakroiliakal]
M99.8Sonstige biomechanische FunktionsstörungenM99.82Sonstige biomechanische Funktionsstörungen : Thorakalbereich [thorakolumbal]
M99.83Sonstige biomechanische Funktionsstörungen : Lumbalbereich [lumbosakral]
M99.84Sonstige biomechanische Funktionsstörungen : Sakralbereich [sakrokokzygeal, sakroiliakal]
M99.9Biomechanische Funktionsstörung, nicht näher bezeichnetM99.92Biomechanische Funktionsstörung, nicht näher bezeichnet : Thorakalbereich [thorakolumbal
M99.93Biomechanische Funktionsstörung, nicht näher bezeichnet : Lumbalbereich [lumbosakral]
M99.94Biomechanische Funktionsstörung, nicht näher bezeichnet : Sakralbereich [sakrokokzygeal, sakroiliakal]
Osteochondrose (Arthrose der Wirbelsäule)M42.-Osteochondrose der WirbelsäuleM42.0-Juvenile Osteochondrose der Wirbelsäule – Inkl.:Scheuermann-Krankheit; Vertebra plana [Calvé-Krankheit] – Exkl.: Kyphose als Haltungsstörung
M42.1-Osteochondrose der Wirbelsäule beim Erwachsenen
M42.9-Osteochondrose der Wirbelsäule, nicht näher bezeichnet
HüfteHüftarthroseM16,-KoxarthroseM16.0Primäre Koxarthrose, beidseitig
M16.1Sonstige primäre Koxarthrose – Inkl.: Primäre Koxarthrose: einseitig; Primäre Koxarthrose: o.n.A.
M16.2Koxarthrose als Folge einer Dysplasie, beidseitig
M16.3Sonstige dysplastische Koxarthrose – Inkl.: Dysplastische Koxarthrose: einseitig; Dysplastische Koxarthrose: o.n.A.
M16.4Posttraumatische Koxarthrose, beidseitig
M16.5Sonstige posttraumatische Koxarthrose – Inkl.: Posttraumatische Koxarthrose: einseitig; Posttraumatische Koxarthrose: o.n.A.
M16.6Sonstige sekundäre Koxarthrose, beidseitig
M16.7Sonstige sekundäre Koxarthrose – Inkl.: Sekundäre Koxarthrose: einseitig; Sekundäre Koxarthrose: o.n.A.
M16.9Koxarthrose, nicht näher bezeichnet
Unspezifische HüftschmerzenM99.8Sonstige biomechanische FunktionsstörungenM99.85Sonstige biomechanische Funktionsstörungen : Beckenbereich [Hüft- oder Schambeinregion]
M99.86Sonstige biomechanische Funktionsstörungen: Untere Extremität
M99.9Biomechanische Funktionsstörung, nicht näher bezeichnetM99.95Biomechanische Funktionsstörung, nicht näher bezeichnet : Beckenbereich [Hüft- oder Schambeinregion]
M99.96Biomechanische Funktionsstörung, nicht näher bezeichnet : Untere Extremität
M25.-Sonstige Gelenkkrankheiten, anderenorts nicht klassifiziertM25.55Gelenkschmerz : Beckenregion und Oberschenkel [Becken, Femur, Gesäß, Hüfte, Hüftgelenk, Iliosakralgelenk]
M25.85Sonstige näher bezeichnete Gelenkkrankheiten : Beckenregion und Oberschenkel [Becken, Femur, Gesäß, Hüfte, Hüftgelenk, Iliosakralgelenk]
M25.95Gelenkkrankheit, nicht näher bezeichnet : Beckenregion und Oberschenkel [Becken, Femur, Gesäß, Hüfte, Hüftgelenk, Iliosakralgelenk]
KnieKniearthroseM17.-GonarthroseM17.0Primäre Gonarthrose, beidseitig
M17.1Sonstige primäre Gonarthrose – Inkl.: Primäre Gonarthrose: einseitig; Primäre Gonarthrose: o.n.A.
M17.2Posttraumatische Gonarthrose, beidseitig
M17.3Sonstige posttraumatische Gonarthrose – Inkl.: Posttraumatische Gonarthrose: einseitig; Posttraumatische Gonarthrose: o.n.A.
M17.4Sonstige sekundäre Gonarthrose, beidseitig
M17.5Sonstige sekundäre Gonarthrose – Inkl.: Sekundäre Gonarthrose: einseitig; Sekundäre Gonarthrose: o.n.A.
M17.9Gonarthrose, nicht näher bezeichnet
Unspezifische KnieschmerzenM99.8Sonstige biomechanische FunktionsstörungenM99.86Sonstige biomechanische Funktionsstörungen: Untere Extremität
M99.9Biomechanische Funktionsstörung, nicht näher bezeichnetM99.96Biomechanische Funktionsstörung, nicht näher bezeichnet : Untere Extremität
M25.-Sonstige Gelenkkrankheiten, anderenorts nicht klassifiziertM25.56Gelenkschmerz : Unterschenkel [Fibula, Tibia, Kniegelenk]
M25.86Sonstige näher bezeichnete Gelenkkrankheiten : Unterschenkel [Fibula, Tibia, Kniegelenk]
M25.96Gelenkkrankheit, nicht näher bezeichnet : Unterschenkel [Fibula, Tibia, Kniegelenk]

Vivira Health Lab GmbH
Kurfürstendamm 54/55, 10707 Berlin
Contact: service@vivira.com