Study: NCT04907162

Intervention type: DIAGNOSTIC_TEST
Intervention: Beck depression inventory fast screen
Description: Beck depression inventory fast screen questionnaire to detect severe depression for eligibility.

Intervention type: DIAGNOSTIC_TEST
Intervention: Beck depression inventory fast screen
Description: Beck depression inventory fast screen questionnaire to detect severe depression for eligibility.

Intervention type: DIAGNOSTIC_TEST
Intervention: German Pain Inventory
Description: German Pain Inventory questionnaire for evaluation of pain. Module A, abbreviated questions of module S (sociodemographic questions S1, S2, S3, S4, S5 and S8) and module L (quality of life) and V (therapies) will be used.

Intervention type: DIAGNOSTIC_TEST
Intervention: German Pain Inventory
Description: German Pain Inventory questionnaire for evaluation of pain. Module A, abbreviated questions of module S (sociodemographic questions S1, S2, S3, S4, S5 and S8) and module L (quality of life) and V (therapies) will be used.

Intervention type: DIAGNOSTIC_TEST
Intervention: Brief Pain Inventory
Description: Validated questionnaire for pain.

Intervention type: DIAGNOSTIC_TEST
Intervention: Brief Pain Inventory
Description: Validated questionnaire for pain.

Intervention type: DIAGNOSTIC_TEST
Intervention: Fatigue Severity and Disability Scale (FSS)
Description: Validated questionnaire for perceived fatigue

Intervention type: DIAGNOSTIC_TEST
Intervention: Fatigue Severity and Disability Scale (FSS)
Description: Validated questionnaire for perceived fatigue

Intervention type: DIAGNOSTIC_TEST
Intervention: Quick Motor Function Test
Description: An evaluator observes the performance of a patient and scores the items separately on a 5-point ordinal scale (ranging from 0 to 4). A total score is obtained by adding the scores of all items and ranges between 0 and 64 points.

Intervention type: DIAGNOSTIC_TEST
Intervention: Quick Motor Function Test
Description: An evaluator observes the performance of a patient and scores the items separately on a 5-point ordinal scale (ranging from 0 to 4). A total score is obtained by adding the scores of all items and ranges between 0 and 64 points.

Intervention type: DIAGNOSTIC_TEST
Intervention: Handheld Dynamometry (HHD)
Description: To ensure a high level of objective measurement, muscle strength will also be assessed by handheld dynamometry. The following muscle groups will be tested: Arm abduction, elbow flexion, elbow extension, hip flexion, hip extension, knee extension, knee flexion, foot extension, foot flexion.

Intervention type: DIAGNOSTIC_TEST
Intervention: Handheld Dynamometry (HHD)
Description: To ensure a high level of objective measurement, muscle strength will also be assessed by handheld dynamometry. The following muscle groups will be tested: Arm abduction, elbow flexion, elbow extension, hip flexion, hip extension, knee extension, knee flexion, foot extension, foot flexion.

Intervention type: DIAGNOSTIC_TEST
Intervention: Six-minute walk test (6MWT)
Description: It is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

Intervention type: DIAGNOSTIC_TEST
Intervention: Six-minute walk test (6MWT)
Description: It is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

Intervention type: DIAGNOSTIC_TEST
Intervention: Pressure pain threshold
Description: For diagnosis of myofascial pain, pressure algometers are designed and conventionally used to measure deep pressure pain thresholds or tenderness resistance (Park, Kim et al. 2011), and the reliability of pressure pain thresholds according to raters or measurement frequencies has been proven to be relatively high (Chung, Um et al. 1992). The threshold is then determined as the arithmetic mean of the 3 series (in kPa). The measurement will be stopped immediately as the patient feels sensations of burning, stinging, drilling or aching. Pressure algometry measurements will be performed on the trapezius, deltoid and supraspinatus muscles, the rectus femoris muscles, and the tibialis anterior muscles.

Intervention type: DIAGNOSTIC_TEST
Intervention: Pressure pain threshold
Description: For diagnosis of myofascial pain, pressure algometers are designed and conventionally used to measure deep pressure pain thresholds or tenderness resistance (Park, Kim et al. 2011), and the reliability of pressure pain thresholds according to raters or measurement frequencies has been proven to be relatively high (Chung, Um et al. 1992). The threshold is then determined as the arithmetic mean of the 3 series (in kPa). The measurement will be stopped immediately as the patient feels sensations of burning, stinging, drilling or aching. Pressure algometry measurements will be performed on the trapezius, deltoid and supraspinatus muscles, the rectus femoris muscles, and the tibialis anterior muscles.

Intervention type: DIAGNOSTIC_TEST
Intervention: Myotonometer Assessment
Description: Muscle stiffness, muscle tone, relaxation periods and viscoelasticity will be assessed by a myotonometer of selected muscles (non-invasive measurement). The method of measurement consists of recording damped natural oscillation of soft biological tissue in the form of an acceleration signal and the subsequent simultaneous computation of the parameters of State of Tension, Biomechanical and Viscoelastic properties. Measurements will be performed on the trapezius, deltoid and supraspinatus muscles, the rectus femoris muscles, and the tibialis anterior muscles.

Intervention type: DIAGNOSTIC_TEST
Intervention: Myotonometer Assessment
Description: Muscle stiffness, muscle tone, relaxation periods and viscoelasticity will be assessed by a myotonometer of selected muscles (non-invasive measurement). The method of measurement consists of recording damped natural oscillation of soft biological tissue in the form of an acceleration signal and the subsequent simultaneous computation of the parameters of State of Tension, Biomechanical and Viscoelastic properties. Measurements will be performed on the trapezius, deltoid and supraspinatus muscles, the rectus femoris muscles, and the tibialis anterior muscles.

Intervention type: DIAGNOSTIC_TEST
Intervention: Vital signs
Description: Vital signs (blood pressure, heart rate, respiratory rate) will be measured before and after the six-Minute-Walk-Test (6MWT).

Intervention type: DIAGNOSTIC_TEST
Intervention: Vital signs
Description: Vital signs (blood pressure, heart rate, respiratory rate) will be measured before and after the six-Minute-Walk-Test (6MWT).

Intervention type: DIAGNOSTIC_TEST
Intervention: Borg Scale
Description: the Borg scale will be assessed, which is a self-reported questionnaire designed to subjectively assess dyspnea and exertion during activity (Borg 1982). The Borg scale rates dyspnea on a scale of 0 to 10 incorporating nonlinear spacing of verbal descriptors of the level of intensity of dyspnea. A higher Borg score indicates more severe dyspnea. The Borg scale will be administered before starting the 6MWT (≤ 5 minutes) and after completing the 6MWT (≤ 5 minutes).

Intervention type: DIAGNOSTIC_TEST
Intervention: Borg Scale
Description: the Borg scale will be assessed, which is a self-reported questionnaire designed to subjectively assess dyspnea and exertion during activity (Borg 1982). The Borg scale rates dyspnea on a scale of 0 to 10 incorporating nonlinear spacing of verbal descriptors of the level of intensity of dyspnea. A higher Borg score indicates more severe dyspnea. The Borg scale will be administered before starting the 6MWT (≤ 5 minutes) and after completing the 6MWT (≤ 5 minutes).