Neuromuscular electro stimulation (NMES) has additional effects on top of tailor made exercise training to counteract the negative effects of sarcopenia .
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Verkorte titel
Aandoening
Sarcopenia should be present. Patients are however admitted to the geriatric ward because of multiple problems mostly acute
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To study the effects of NMES on top of exercise training on physical function and skeletal muscle mass in acutely ill sarcopenic hospitalized geriatric patients. Effects will be measured with the timed Chair Stand Test (t-CST), knee extension force (KEF) assessed with a handheld dynamometer ( MicroFet-2) and skeletal muscle mass of the upper leg (ul-SMM) with multifrequency bio-impedance analysis (mf-BIA). The difference in percentage of patients with changes on these parameters (t-CST, KEF and ul-SMM) in the IG compared to the patients in the CG.
Achtergrond van het onderzoek
Rationale: Aging is associated with loss of skeletal muscle mass and strength, called sarcopenia. Sarcopenia is highly prevalent in hospitalized geriatric patients. It is probably one of the most important causes of functional decline in acutely ill hospitalized geriatric patients. Resistant training is the best therapy to counteract sarcopenia, however geriatric patients are not able to perform this resistance training. Neuromuscular electrostimulation (NMES) could be an alternative way to counteract the negative effects of sarcopenia. In previous studies effectivity and feasibility was demonstrated in different populations. However no studies with NMES are performed in the acutely ill hospitalized geriatric patient with sarcopenia.
Objective: Effects of NMES on physical function and skeletal muscle mass
Study design: Prospective randomised intervention study. Patients will be randomised in two groups: control group (CG) of 30 patients and an intervention group (IG) of 30 patients. The patients in the CG get usual care including physical therapy and patients in the IG get on top neuromuscular electrostimulation (NMES) during 60 minutes a day during 5 days on consecutively working week days. At baseline and at the end of the study physical function will be assessed with timed chair stand test (t-CST), knee extension strength (KES) of the upper legs with a handheld dynamometer (MicroFet-2) and skeletal muscle mass of the upper leg (ul- SMM) with bio-impedance analysis (Maltron Bioscan-II). A questionnaire will be used to assess possible adverse events.
Study population: Acutely ill geriatric patients with sarcopenia admitted to the acute care geriatric ward of Zuyderland Medical Centre.
Intervention (if applicable): The patients in the CG will get usual care with daily physical therapy and the patients in the IG will get NMES (50Hz (10-100 Hz), 400 microsec (100-1000 ms), duty cycle 33% (0-100%)) during 60 minutes a day of the quadriceps muscle on both legs during 5 days. The amplitude will be set individually and have to result in visible muscle contractions and must be tolerated by the patients.
Main study parameters/endpoints: Primary endpoint is the difference in percentage of patients in the IG compared to the patients in the CG with changes on the t-CST. The secondary endpoints are the differences in percentages of patients in the IG compared to the patients in the CG with changes in KES and changes in ul-SMM.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Serious adverse events are not expected. Temporarily muscle strain, fatigue and skin rash are possible side effects of NMES. We expect an improvement of physical functioning with a better chair rise, improvement of strength of the quadriceps muscles and finally counteract loss of skeletal muscle mass.
Doel van het onderzoek
Neuromuscular electro stimulation (NMES) has additional effects on top of tailor made exercise training to counteract the negative effects of sarcopenia .
Onderzoeksopzet
Baseline and after 5 days NMES on top of tailor made exercise training in the IG or in CG after 5 days tailor made exercise training
Onderzoeksproduct en/of interventie
The patients in the control group (CG) will get usual care with daily physical therapy and the patients in the intervention group (IG) will get on top NMES during 5 days on working weekdays during 60 minutes a day. The NMES basic settings are: 50Hz (10-100 Hz), 400 microsec (100-1000 ms) with a duty cycle of 33% (0-100%) based on the earlier studies.5,6,14 NMES of the quadriceps muscle on both legs will be done simultaneously. The amplitude will be tapered by the researcher in agreement with the individual patient and have to result in visible muscle contractions. These muscle contractions have to be tolerated by the patients and the maximum of the amplitude is there for individualized
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Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a patient must meet all of the following criteria: aged 70 years and older, being frail according the Groningen Frailty Indicator (GFI score >3) and they should be sarcopenic according the European Working Group On Sarcopenia-2 criteria (EWGSOP-2) based on handgrip strength (men < 27kg and women < 16kg)), appendicular skeletal muscle mass (men < 7.0 kg/l2 and women < 7.0 kg/l2) and physical function below cut-off values (Short Physical Performance Battery <9). In a study done by Sipers et all in this population 92% of the men and 67% of the women were sarcopenic.3 Inclusion and first measurement should be done within the first three days after hospitalization.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential patient will be excluded from participation in this study if he/she meets any of the following criteria: Inability to walk prior index disease or problem before hospitalization. If a patient has a terminal condition e.g. due to metastatic cancer with a limited survival time (less than 3 month). Inability to walk due to pain or palsy during hospital stay. If a patient is not instruct able. If a patient has an implantable cardioverter defibrillator (ICD) or no informed consent.
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In overige registers
Register | ID |
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NTR-new | NL8454 |
Ander register | METC Zuyderland-Zuyd : METCZ20190134 |