Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Paracelsus Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
Exercise in general and resistance training (RT) in particular have demonstrated positive effects on physical functioning and frailty. However, frail older people with functional impairments are among the least physically active and may have problems reaching high intensity levels. The use of special vests with integrated electrodes allows the simultaneous innervation of all large muscle groups by external electrical stimulation, inducing a high-intensity RT at low subjective effort level. This whole-body electromyostimulation (WB-EMS) may be a feasible option inducing training stimuli for functionally impaired frail older people.
This study aims at investigating the feasibility and safety of WB-EMS in frail older people with functional limitations. To explore the effects of age and functional status, young and robust old reference groups will serve as comparators.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WB-EMS_frail | Experimental |
| |
| WB-EMS_robust | Active Comparator |
| |
| WB-EMS_young | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole-Body Electromyostimulation | Other | Whole-Body Electromyostimulation (WB-EMS): Simultaneous, individually adjustable stimulation of 12 muscle groups using an interval approach with a duty cycle of 6s impulse/4s rest, bipolar electric current (impulse -frequency 85Hz, -width 350μs, rectangular pattern) will be applied. After a 4-week conditioning period, 1.5x 20 min/week WB-EMS will be conducted for 4 weeks (total training duration 8 weeks). Easy to perform functional exercises focusing on balance, transfer ability, stepping and lower extremity strength/power will be done during WB-EMS. Exercise intensity will be individually prescribed and adjusted by rate of perceived exertion (RPE-Borg CR10 scale 4 (moderate) to 7 (hard)). WB-EMS will be fully supervised one on one. All three arms will receive the same intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | measured by ratio of included/eligible participants | 8 weeks |
| Compliance | measured by proportion of attended training sessions | from baseline to 8 weeks |
| Retention rate | measured by proportion of participants remaining in the study | at 8 weeks |
| Dropout rate | measured by the proportion of participants not completing the study | from baseline to 8 weeks |
| Perceived enjoyment measured by the Physical Activity Enjoyment Scale for Older Adults (PACES-8) | The PACES-8 comprises of 8 items on a 7-point bipolar rating scale. A sum score is calculated with higher PACES scores reflecting greater levels of enjoyment. | Change from baseline to 8 weeks |
| Intervention engagement measured by the Hopkins Rehabilitation Engagement Scale (HRERS) | The HRERS, reported by instructors, comprises of 5 items on a verbal rating scale from 'Never' to 'Always'. Higher scores reflect greater levels of engagement. | at 8 weeks |
| Concentration of Myoglobin (MB) | Concentration of MB measured in µg/l 3 hours after training | measured at baseline to week 1, week 3 and week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Rhabdomyolysis surveillance measured by a self-developed questionnaire | The questionnaire is to be filled out before, immediately after and 24 hours following training and containing information on specific (dark urine, muscle weakness, muscle pain) and unspecific (tachycardia, fever, general malaise, nausea, vomiting) symptoms and other adverse events (e.g. falls) | measured weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life measured by the patient-reported Health Survey Short Form (SF-12) | The SF-12 comprises of 12 items weighted and summed to provide physical and mental health scores (PCS and MCS), ranging from 0 to 100 with higher scores reflecting greater levels of the respective construct. | Change from baseline to 9 weeks |
Frail people
Inclusion Criteria:
Exclusion Criteria:
Robust people
Inclusion Criteria:
Exclusion Criteria:
Younger people
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Medical Physics, University of Erlangen-Nürnberg | Erlangen | 91052 | Germany |
Not provided
| ID | Term |
|---|---|
| D000073496 | Frailty |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
Not provided
Not provided
frail older people (n=10) pre-post; robust older (n=10) and young (n=10) reference groups with identical intervention
Not provided
Not provided
Not provided
Not provided
|
| Concentration of Creatinkinase (CK) |
Concentration of CK measured in U/l before, 48, 72 hours after training |
| measured at baseline to week 1, week 3 and week 8 |
| estimated glomerular filtration rate (eGFR) | eGFR (creatinine clearance) measured in mL/min/1.73m² before, 48, 72 hours after training | measured at baseline to week 1, week 3 and week 8 |
| Pain assessed by the Brief Pain Inventory (BPI-SF) | The BPI-SF comprises of 15 items asking questions on pain location, severity and interference and scored from 0 to 10 with higher scores indicating worse outcomes. | measured at baseline to week 1, week 3 and week 8 |
| Fatigue assessed by the Brief Fatigue Inventory (BFI) | The BFI comprises of 10 items asking questions on fatigue severity and interference and scored from 0 to 10 with higher scores indicating worse outcomes. | measured at baseline to week 1, week 3 and week 8 |
| System usability measured by the System Usability Scale (SUS) | The SUS, reported by instructors, comprises of 10 items on a 5-point Likert scale from 1 ('strongly disagree') to 5 ('strongly agree'). Higher scores reflect greater levels of usability. | once at 8 weeks |
| Lower extremity functioning measured by the Short Physical Performance Battery (SPPB) | The SPPB comprises of three dimensions, balance (static - standing in 3 positions of increasing difficulty by reducing base of support for max. 10s), gait (usual pace - two walks of 4m lengths), functional strength (chair rise - five times sit-to-stand transfers as fast as possible). A sum score is calculated (0-12 points) with higher scores indicating better functional status and each dimension being equally weighed (0-4 points). | Change from baseline to 9 weeks |
| Mobility measured by the Timed up & go test (TUG) | The TUG requires the participants to stand up from chair, walk at usual pace to line at 3m, turn, walk back and sit down again. The time in seconds is recorded. | Change from baseline to 9 weeks |
| Maximum knee/hip extension strength | Isokinetic leg press in Newton | Change from baseline to 9 weeks |
| Skeletal muscle mass | Bioelectrical impedance analysis (BIA) | Change from baseline to 8 weeks |
| Rate of persons with Albuminuria | Rate of persons with Albuminuria ≥ 2+ measured with a semi quantitative urine dipstick 24 hours after training | measured at baseline to week 1, week 3 and week 8 |
| Rate of persons with Proteinuria | Rate of persons with Proteinuria ≥ 3+ measured with a semi quantitative urine dipstick 24 hours after training | measured at baseline to week 1, week 3 and week 8 |
| Concentration of Urea | Concentration of Urea measured in mg/dl before, 48, 72 hours after training | measured at baseline to week 1, week 3 and week 8 |
| Concentration of Cystatin C | Concentration of Cystatin C measured in mg/l before, 48, 72 hours after training | measured at baseline to week 1, week 3 and week 8 |
| Concentration of Creatinine | Concentration of Creatinine measured in mg/dl before, 48, 72 hours after training | measured at baseline to week 1, week 3 and week 8 |
| Concentration of Sodium | Concentration of Sodium measured in mmol/l before, 48, 72 hours after training | measured at baseline to week 1, week 3 and week 8 |
| Concentration of Potassium | Concentration of Potassium measured in mmol/l before, 48, 72 hours after training | measured at baseline to week 1, week 3 and week 8 |
| Concentration of Calcium | Concentration of Calcium measured in mmol/l before, 48, 72 hours after training | measured at baseline to week 1, week 3 and week 8 |
| Concentration of Phosphate | Concentration of Phosphate measured in mmol/l before, 48, 72 hours after training | measured at baseline to week 1, week 3 and week 8 |
| Concentration of Interleukin 6 (IL-6) |
Concentration of IL-6 measured in ng/l before, 3h, 48, 72 hours after training |
| measured at baseline to week 1, week 3 and week 8 |
| Concentration of High-sensitivity C-reactive protein (hs CRP) | Concentration of hs CRP measured in mg/l before, 48, 72 hours after training | measured at baseline to week 1, week 3 and week 8 |
| Concentration of Cholesterin | Concentration of Cholesterin measured in mg/dl before first and last trainings | measured at baseline and week 8 |
| Concentration of low-density lipoprotein (LDL) | Concentration of LDL measured in mg/dl before first and last trainings | measured at baseline and week 8 |
| Concentration of high-density lipoprotein (HDL) | Concentration of HDL measured in mg/dl before first and last trainings | measured at baseline and week 8 |
| Concentration of Triglycerides | Concentration of Triglycerides measured in mg/dl before first and last trainings | measured at baseline and week 8 |
| Concentration of N-terminal pro b-type natriuretic peptide (NT-proBNP) | Concentration of NT-proBNP measured in pg/ml before, 48, 72 hours after training | measured at baseline to week 1, week 3 and week 8 |
| Concentration of Glucose | Concentration of Glucose measured in mg/dl before first and last trainings | measured at baseline and week 8 |
| Concentration of Creatinkinase Muscle/Brain (CK-MB (CK-2)) | Concentration of CK-MB (CK-2) measured in ng/ml before, 48, 72 hours after training | measured at baseline to week 1, week 3 and week 8 |
| Concentration of high-sensitive cardiac troponin T (hs-cTnT) | Concentration of hs-cTnT measured in ng/ml before, 48, 72 hours after training | measured at baseline to week 1, week 3 and week 8 |