„ViViRA“- Instruction for use

1. Purpose and General Information

The DiGA ViViRA is a digital app for the treatment of back pain in non-specific back pain or arthrosis of the spine (osteochondrosis) that has been finally included in the DiGA directory by the BfArM. The app can be used according to a doctor's prescription and without a doctor's prescription. It offers, among other things, personalized and therapeutic training content that adapts based on user feedback, ways to monitor training activity and disease progression, ways to test movement ability, and knowledge articles on musculoskeletal health. These instructions for use describe how to use the ViViRA app as intended.
 
Before using the app, a doctor should confirm that ViViRA is suitable for you and your particular health situation.
 
ViViRA does not provide medical or therapeutic diagnosis or treatment.
 
Read these instructions carefully and completely before using ViViRA. Please pay particular attention to the following sections:
 
Section 2: Legal requirements for the use and processing of your data.
Section 3: Technical and medical conditions for use and contraindications
Section 4: Safety Instructions and Side Effects
 
Training with ViViRA can be done without supervision by a doctor or therapist.
 
Frequency of use
Unless otherwise instructed by a doctor, you should do one ViViRA training session of 4 exercises per day, at least 3 days per week.
 
Duration of use
The duration of use is limited to 90 days per prescription. If further therapy is needed, follow-up prescriptions may follow. There is no general duration of use to be observed. However, in case of complaints, a doctor should be consulted.
 
Note
Image excerpts from the app used in the instructions for use show the display on Apple devices. The display on devices using the Android operating system may differ slightly from this display.
Questions can be sent to service@diga.vivira.com at any time.
 

2. Legal requirements for the application, processing of your data

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

• Are at least 18 years old
• Have read and accepted the ViViRA General Terms and Conditions of Business
• Have read and accepted the ViViRA Privacy Policy and consent to the processing of your personal health data by ViViRA.

You can find our currently valid privacy policy at: www.vivira.com/datenschutzerklaerung/. You can revoke your consent to the processing of your data at any time in the ViViRA app under Profile > Settings > Manage your data.

3. Requirements for use and contraindications

3.1. Technical requirements for the application

ViViRA is currently compatible with operating systems from Android 7.0 and iOS 14.0.
In order to be able to use the ViViRA service to its full extent, you should urgently keep both the ViViRA App and the operating system of your end device up to date ("Updates"). We recommend that you check both the operating system and the ViViRA for updates at least once a month. If older or not commonly used software is used, you may be limited or unable to use the services, or you may become a target of cyberattacks.

It is not possible to use the service without a stable broadband internet connection.
 

3.2. Medical condition for use

A prerequisite for using the programs is a stable general state of health.

If you experience pain, discomfort, or loss of function during or after using the app, you should stop the program and, if necessary – at your own discretion – consult a doctor.

Pause ViViRA if

• severe pain
• swollen or very warm joints
• fever
• general feelings of illness

3.3. Contraindications

ViViRA may only be used if none of the following absolute contraindications are present.

Acute inflammation or fever
Do not use ViViRA if you have an acute infection or fever.
 
Spinal or joint infection
Do not use ViViRA if you have been diagnosed with a spinal, hip or knee infection.

3.3.2. Relative contraindications
In addition to the contraindications mentioned above, there are other restrictions that you should observe so that nothing stands in the way of a successful therapy. If one of the following points applies to you, please discuss the use of ViViRA with your doctor beforehand.

Under neurological treatment
Do not use the app if you are receiving medical treatment for a stroke, paralysis, MS or seizure disorder.

Previous spinal surgery
Do not use the ViViRA app if you have had spinal surgery.

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

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 less than 2 flights of stairs, or other unexplained cardiovascular conditions (e.g. palpitations, unexplained swelling of the legs, cough).

Rheumatic disease
Do not use the ViViRA App if you have a known rheumatic disease.

Decreased bone density
Do not use the ViViRA App if you have known low bone density (age-related bone loss or other medical reasons).

Gait unsteadiness 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 taking anticoagulant medications
Do not use the ViViRA App if you suffer from increased bleeding, if you have a hereditary bleeding disorder or if you are taking medication that inhibits your blood clotting.

Pregnancy
Do not use the ViViRA App if you are pregnant or think you may be pregnant.

Cancer
Do not use ViViRA without first consulting a doctor if you have an active cancer.

Methodological exclusion criteria specific to the study
Severe organ failure Exclusion of study participants with a history of cardiovascular events, chronic renal failure and chronic lung disease.

Acute instability of knee & hip
Exclusion of study participants with existing knee joint and/or hip joint instability.

3.4. ACCESSIBILITY
The app is not accessible and not suitable for users with visual impairments.

4. Safety instructions and side effects

4.1. Safety instructions

4.2. Specific advice and warnings

Non-specific back pain

• Note: Back pain in particular is often associated with stress, exercise and lack of sleep. This is called non-specific back pain. Only select "Non-specific back pain" from the list of medical indications in the app if you ...
  • do not feel any radiation in the legs
  • do not have a slipped disc
  • do not have scoliosis

• Warnung: Wenn du starke Rückenschmerzen hast, solltest du dein Training unterbrechen und einen Arzt aufsuchen.

Osteoarthritis of the back (osteochondrosis)

Note: Osteoarthritis is a degenerative change in the cartilage that covers the joint surfaces. Colloquially, it is also referred to as "joint wear and tear". Osteoarthritis is characterised by pain and restricted movement in the joint and is often accompanied by morning stiffness that improves with movement.

Warning: Exercise often helps with osteoarthritis pain, which can sometimes be weaker and sometimes stronger. Start exercising slowly so you don't overexert yourself. Reduce the intensity of exercise or skip painful exercises if your pain persists.
 
4.3. Side effects
Side effects are undesirable effects that may occur when using the app as intended. What are the possible side effects?

• Temporary, mild pain due to overuse of joints, muscles or tendons.

For the information at this point, reported side effects that occurred in at least one in 50,000 ViViRA installations were considered. We are not aware of any other side effects at the time of writing this leaflet.

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

• Pain in the legs, knees, back of the hands
• Ischialgiform pain in the area of the lumbar spine due to irritation of the nerve exit points from the spine
• Irritation of joints with impaired function
• Swelling
• Itching

4.4. Reporting adverse effects or events
If you notice an adverse effect (e.g. a discomfort or change) while using ViViRA, send us a message directly from the app (Profile > Settings > Send us a message) or email us at service@diga.vivira.com. You can also contact a doctor to report an adverse effect.
 

5. Therapy concept

ViViRA is based on movement therapy.

"Exercise therapy is a physiotherapy procedure to increase resilience and restore normal body functions through systematic and individually adapted physical exercises." (Pschyrembel Clinical Dictionary)

Exercise therapy is part of the guidelines for the treatment of non-specific and degenerative back pain and is thus a recognised professional standard. In addition, the positive effect of exercise therapy on pain reduction has been scientifically proven.

Within the framework of movement therapy, ViViRA specifically addresses mobility (mobility), stability (strength) and coordination through regular self-exercises. "Mobility is the combination of muscle flexibility and range of motion of the joint, both together form the mobility of a body part.(...) Stability describes the maintenance of posture and the control of fundamental movements. It therefore requires strength in different joint positions, at different speeds of movement and in combinations of these. (...) Coordination, or the correct neuromuscular control, is the third essential pillar of a movement. What is meant by this is the ability of our brain to control a movement and to control its course." (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 supra-regional dependencies and related muscle chains. ViViRA training thus follows a holistic therapy approach to support the strengthening of the body in its entire range of motion.

You can find more literature on the therapy concept in the ViViRA app in the "Knowledge" section under "ViViRA therapy concept".
 

6. Introduction and set-up of your Vivira account

In the introduction to the app, you answer questions about yourself, your area of complaint, any medical findings and movement restrictions. Your training program is configured from this information.
 
Shortly before the end of the introduction, the app will ask you to enter your email address and a password of your choice to set up your ViViRA account. To verify your identity, we will send you an email that you must confirm.

We also need your email address so that we can contact you with important product safety notifications. ViViRA will never share your email address with third parties or use it for promotional purposes. Please use a secure password that only you know and that consists of at least 8 characters, including at least one upper and lower case letter and at least one number.

If you have received an activation code for ViViRA from your health insurance company, you can enter it on the code activation screen. For iOS users (iOS version 16.0 and above), you may also scan the code on your insurance letter.

As soon as you have completed the introduction and set up your ViViRA account, you can use the ViViRA app for therapeutic training!

7. Daily exercises

7.1. Basic information

In the app, after setting up your ViViRA account, you will receive 4 exercises per day. After each exercise, you give feedback on whether the exercise triggered or intensified pain and whether you were able to perform all repetitions. The exercises in your training plan change in intensity and complexity according to your input.

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

8. Weekly progress report

8.1. Basic information

The app asks you to answer a weekly progress log with seven questions about pain, limitations and your therapeutic treatment.

9. Monthly movement test

9.1. Basic information

Every month, the app asks you to perform a movement test with 15 movements. A movement score is calculated using the information you provide after each movement.

10. Steps

10.1. Basic information

The app allows you to record the steps you take every day.

10.2. Entry via the Today page

You access the entry area via the Today page in the app by tapping the "Enter steps" field under the exercise card.

11. Visualisation of activity and progress

11.1. Basic information

Your daily training activity, your progress log, your exercise test scores and your daily steps are visually displayed in the app so that you can follow their progress over time at any time.

12. Sharing programme and history data

12.1. Basic information

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.

13. Knowledge article

13.1. Basic information

In addition to the training, you can read knowledge articles on musculoskeletal health topics in the app to support the training effect.

14. Settings

14.1. Basic information

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

15. Tips for training with Vivira

To start your training with ViViRA, read in particular the knowledge articles “About ViViRA” in the top row of knowledge articles. These will give you a basic understanding of the ViViRA training philosophy and a suitable weekly routine. They also give tips on what can be done if exercises are either too difficult for you or not challenging enough. 

16. Further information