- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03409575
Efficacy of Neuromuscular Electrical Stimulation in Geriatric Population
Efficacy of Two Different Method of Neuromuscular Electrical Stimulation on Quadriceps Strength, Fatigue and Physical Function in Geriatric Population
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Ordu, Kalkun, 52100
- Sevim ACARÖZ CANDAN
-
-
Altinordu
-
Ordu, Altinordu, Kalkun, 52100
- Sevim ACARÖZ CANDAN
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria includes
- age 60 years or older
- be able to climb one floor of stairs independently
- not participate in an exercise program to increase strength or physiotherapy programme.
Exclusion Criteria:
- having a medical condition in which NMES training is contraindicated
- having a cognitive impairment
- having implanted cardiac pacemaker
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: 5 minutes stimulation
The biphasic, symmetrical waveform will be used.
The 100 Hz current will be applied for 5 minutes.
|
Before the NMES application, warming exercises will be performed on the lower extremity muscles for 5 minutes.
NMES will be administered through Compex device (Physio, Chattanooga Corporation, Chattanooga, U.S.A.).
Quadriceps will be stimulated bilaterally for 3 sessions per week for 6 weeks (totally 18 sessions).
Four electrodes will be used on the femoral nerve, and motor points of the rectus femoris, vastus medialis, lateralis.The biphasic, symmetrical waveform will be used.
The 100 Hz current will be applied for 5 minutes by 5 sec on: 15 sec off and than the muscle will be rested for 10 minutes.
5 minutes of NMES will be made in 4 sets.
Fifteen contractions will be received at each set.
The intensity of the current will be increased until the visible contraction is taken.
|
Andet: 10 minutes stimulation
The biphasic, symmetrical waveform will be used.
The 100 Hz current will be applied for 10 minutes.
|
Before the NMES application, warming exercises will be performed on the lower extremity muscles for 5 minutes.
NMES will be administered through Compex device (Physio, Chattanooga Corporation, Chattanooga, U.S.A.).
Quadriceps will be stimulated bilaterally for 3 sessions per week for 6 weeks (totally 18 sessions).
Four electrodes will be used on the femoral nerve, and motor points of the rectus femoris, vastus medialis, lateralis.The biphasic, symmetrical waveform will be used.
The 100 Hz current will be applied for 10 minutes by 5 sec on: 15 sec off and than the muscle will be rested for 10 minutes.
10 minutes of NMES will be made in 2 sets.
Thirty contractions will be received at each set.
The intensity of the current will be increased until the visible contraction is taken.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Timed up and go test
Tidsramme: 2 minutes
|
This test will be used to measure the progress of balance, sit to stand, and walking. The participants stands up upon therapist's command walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. Time will be recorded. |
2 minutes
|
30-Second Chair Stand Test
Tidsramme: 30 second
|
The 30CST is a measurement that assesses functional lower extremity strength in older adults.
The participant is encouraged to complete as many full stands as possible within 30 seconds.
The participant is instructed to fully sit between each stand.The score is the total number of stands within 30 seconds (more than halfway up at the end of 30 seconds counts as a full stand).
Incorrectly executed stands are not counted.
|
30 second
|
6 minute walk test
Tidsramme: 6 minute
|
The 6 Minute Walk Test 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.
The participant walk for 6 minutes on 30 meter long way.
The total distance will be recorded at the end of the test.
|
6 minute
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Grip Strength
Tidsramme: 5 minutes
|
The patient wiil squeeze the dynamometer as the arm is adjacent to the body, the elbow is at 90 ° flexion, the forearm is in the neutral position and the wrist is at 0-30 ° extension.
After the test is repeated three times, the highest score will be recorded.
The test will only be done for the dominant hand.
|
5 minutes
|
Berg Balance Scale
Tidsramme: 10 minutes
|
The balance will be evaluated observational during 14 different balance activities. A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. It's minimum and maximum scores ranged between 0 and 56. Interpretation: 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk |
10 minutes
|
Strength of Quadriceps muscle
Tidsramme: 5 minutes.
|
Lafayette manuel muscle tester will be used to determine the strength of the Quadriceps.
The strength will be evaluated bilaterally three times and then the maximum value will be recorded.
|
5 minutes.
|
Short Physical Performance Battery
Tidsramme: 3 minutes
|
The battery is an objective assessment tool for evaluating lower extremity functioning in older persons.
The battery is scored between 0-12 scores according to the balance, chair stand test performance and gait speed of the participant.
|
3 minutes
|
Fatigue Severity Scale
Tidsramme: 5 minutes
|
The 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders.
Each item is scored between1 and 7. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement.
A total score of 36 or more suggests that you may be suffering from the fatigue.
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5 minutes
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sevim A CANDAN, T.C. ORDU ÜNİVERSİTESİ
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AR-1665
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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